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Trial record 53 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00040846
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : March 16, 2017
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brenda Sandmaier, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Peripheral T-cell Lymphoma
Previously Treated Myelodysplastic Syndromes
Progressive Hairy Cell Leukemia, Initial Treatment
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Anaplastic Large Cell Lymphoma
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Refractory Multiple Myeloma
Relapsing Chronic Myelogenous Leukemia
Splenic Marginal Zone Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Childhood Anaplastic Large Cell Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Stage I Marginal Zone Lymphoma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage I Small Lymphocytic Lymphoma
Stage II Childhood Anaplastic Large Cell Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Childhood Anaplastic Large Cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Childhood Anaplastic Large Cell Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Stage IV Small Lymphocytic Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Waldenström Macroglobulinemia
Interventions Biological: alemtuzumab
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: mycophenolate mofetil
Drug: cyclosporine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Period Title: Overall Study
Started 60 0 0 0 0 0
Completed 60 0 0 0 0 0
Not Completed 0 0 0 0 0 0
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath) Total
Hide Arm/Group Description

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 60 0 0 0 0 0 60
Hide Baseline Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 0 participants 0 participants 0 participants 0 participants 0 participants 60 participants
<=18 years
1
   1.7%
1
   1.7%
Between 18 and 65 years
52
  86.7%
52
  86.7%
>=65 years
7
  11.7%
7
  11.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 0 participants 0 participants 0 participants 0 participants 0 participants 60 participants
56.7
(13 to 72)
56.7
(13 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 0 participants 0 participants 0 participants 0 participants 0 participants 60 participants
Female
15
  25.0%
15
  25.0%
Male
45
  75.0%
45
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 0 participants 0 participants 0 participants 0 participants 0 participants 60 participants
60 60
1.Primary Outcome
Title Evaluate the Risk of Transplant Related Mortality.
Hide Description Percentage patients with Day 100 transplant related mortality.
Time Frame 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Overall Number of Participants Analyzed 60 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
20
2.Primary Outcome
Title Evaluate the Risk of Occurrence of Acute and Chronic GVHD
Hide Description

Percentage patients who developed acute/chronic GVHD.

aGVHD Stages

Skin:

  1. a maculopapular eruption involving < 25% BSA
  2. a maculopapular eruption involving 25 - 50% BSA
  3. generalized erythroderma
  4. generalized erythroderma with bullous formation and often with desquamation

Liver:

  1. bilirubin 2.0 - 3.0 mg/100 mL
  2. bilirubin 3 - 5.9 mg/100 mL
  3. bilirubin 6 - 14.9 mg/100 mL
  4. bilirubin > 15 mg/100 mL

Gut:

Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.

aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time Frame 1 year after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Overall Number of Participants Analyzed 60 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
Grade III-IV aGVHD 23.3
cGVHD 41.7
3.Primary Outcome
Title Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
Hide Description Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.
Time Frame 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Overall Number of Participants Analyzed 60 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
CD3 - Graft rejection 3.3
CD3 - Mixed chimerism 18.3
CD3 - Full donor chimerism 70
CD3 - Unknown 8.33
CD33 - Graft Rejection 1.7
CD33 - Mixed chimerism 3.3
CD33 - Full donor chimerism 80
CD33 - Unknown 15
4.Secondary Outcome
Title Evaluate the Risk/Incidence of Infections
Hide Description Percentage patients who experienced infections within 100 days post-transplant.
Time Frame 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Overall Number of Participants Analyzed 60 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
91.7
5.Secondary Outcome
Title Evaluate the Risk for Disease Progression and Relapse
Hide Description Percentage patients who relapsed/progressed within 1 year post-transplant.
Time Frame 1 year after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description:

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

Overall Number of Participants Analyzed 60 0 0 0 0 0
Measure Type: Number
Unit of Measure: percentage of participants
21.7
Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Adverse Event Reporting Description No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
 
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Hide Arm/Group Description

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

fludarabine phosphate: Given IV

total-body irradiation: Undergo TBI

allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT

peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation

mycophenolate mofetil: Given PO

cyclosporine: Given IV or PO

alemtuzumab: Given IV

All-Cause Mortality
Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/60 (40.00%)      0/0      0/0      0/0      0/0      0/0    
Cardiac disorders             
Cardiac troponin I increased   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Heart failure   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Gastrointestinal disorders             
Gastric perforation   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
General disorders             
Multi-organ failure   4/60 (6.67%)  4 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Immune system disorders             
GVHD   8/60 (13.33%)  8 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Infections and infestations             
Sepsis   5/60 (8.33%)  5 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Secondary Malignancy   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Nervous system disorders             
Leukoencephalopathy   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders             
Hypoxia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Pleural hemorrhage   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Respiratory failure   3/60 (5.00%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Vascular disorders             
Thromboembolic event   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/60 (55.00%)      0/0      0/0      0/0      0/0      0/0    
Blood and lymphatic system disorders             
Blood and lymphatic system disorders - Other (Coagulopathy)   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Febrile neutropenia   2/60 (3.33%)  2 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hemolysis   2/60 (3.33%)  2 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Anemia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Blood and lymphatic System Disorder - Other (Hemoptysis)   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Cardiac disorders             
Atrial fibrillation   2/60 (3.33%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Myocardial infaction   3/60 (5.00%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Ventricular arrhythmia   3/60 (5.00%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Heart Failure   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Gastrointestinal disorders             
Abdominal pain   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Diarrhea   2/60 (3.33%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Gastric hemorrhage   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Immune system disorders             
Anaphylaxis   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Infections and infestations             
Infections and infestations - Other (Blood)  [1]  1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Lung infection   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Sepsis   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Injury, poisoning and procedural complications             
Spinal injury   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Investigations             
Aspartate aminotransferase increased   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Blood bilirubin increased   13/60 (21.67%)  13 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Creatinine increased   5/60 (8.33%)  5 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Neutrophil count decreased   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Metabolism and nutrition disorders             
Anorexia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Dehydration   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hyperglycemia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hyperkalemia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hypokalemia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hyponatremia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Tumor lysis syndrome   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Nervous system disorders             
Ataxia   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Leukoencephalopathy   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Renal and urinary disorders             
Acute kidney injury   2/60 (3.33%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Renal and urinary disorders - Other (BUN increased)   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders             
Adult respiratory distress syndrome   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hypoxia   10/60 (16.67%)  12 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Pleural effusion   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Respiratory failure   2/60 (3.33%)  2 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Bronchopulmonary hemorrhage   1/60 (1.67%)  1 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Vascular disorders             
Capillary leak syndrome   2/60 (3.33%)  2 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hypertension   3/60 (5.00%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Hypotension   4/60 (6.67%)  4 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Thromboembolic event   3/60 (5.00%)  3 0/0  0 0/0  0 0/0  0 0/0  0 0/0  0
Indicates events were collected by systematic assessment
[1]
Gram negative bacteremia, resulting in death
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brenda M. Sandmaier
Organization: Fred Hutchinson Cancer Research Center
Phone: (206) 667-4961
EMail: bsandmai@fhcrc.org
Layout table for additonal information
Responsible Party: Brenda Sandmaier, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00040846     History of Changes
Other Study ID Numbers: 1591.00
NCI-2011-00471 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1591.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
P01CA018029 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2002
First Posted: January 27, 2003
Results First Submitted: January 26, 2017
Results First Posted: March 16, 2017
Last Update Posted: June 6, 2019