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Trial record 39 of 66 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00118352
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
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 Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Juvenile Myelomonocytic Leukemia
Mast Cell Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Lymphoblastic Leukemia
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 Grade III Lymphomatoid Granulomatosis
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
Secondary Myelodysplastic Syndromes
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: alemtuzumab
Radiation: total-body irradiation
Drug: fludarabine phosphate
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Biological: graft versus host disease prophylaxis/therapy
Other: laboratory biomarker analysis
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

NOTE: No subjects were enrolled at this dose level as the escalation rule was not met.

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

NOTE: No subjects were enrolled at this dose level as the escalation rule was not met.

Period Title: Overall Study
Started 12 0 0
Completed 12 0 0
Not Completed 0 0 0
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath) Total
Hide Arm/Group Description

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Total of all reporting groups
Overall Number of Baseline Participants 12 0 0 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 0 participants 12 participants
<=18 years
0
   0.0%
0 0
0
   0.0%
Between 18 and 65 years
10
  83.3%
0 0
10
  83.3%
>=65 years
2
  16.7%
0 0
2
  16.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 0 participants 0 participants 12 participants
58.6
(44 to 71)
58.6
(44 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 0 participants 12 participants
Female
6
  50.0%
6
  50.0%
Male
6
  50.0%
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 0 participants 0 participants 12 participants
12 12
1.Primary Outcome
Title Incidence of Grade III-IV Acute GVHD
Hide Description

Severity of Individual Organ Involvement

Liver:

Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml

Gut:

Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 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

Severity of GVHD

Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 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 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
25
2.Secondary Outcome
Title Incidence of Graft Rejection
Hide Description Percentage patients that experienced graft rejection.
Time Frame 84 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Incidence of High-dose Corticosteroid Utilization.
Hide Description Percentage patients requiring steroids greater than 1 mg/kg.
Time Frame 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
83.3
4.Secondary Outcome
Title Incidence of Non-relapse Mortality
Hide Description Percentage patient deaths due to non-relapse mortality
Time Frame 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
8.3
5.Secondary Outcome
Title Incidence of Infection
Hide Description Percentage patients that experienced infection(s).
Time Frame Up to 5 years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
100
6.Secondary Outcome
Title Immune Reconstitution
Hide Description The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.
Time Frame Up to 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Disease Progression/Relapse
Hide Description

CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.

AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.

CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter’s transformation.

NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.

MM

≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description:

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Overall Number of Participants Analyzed 12 0 0
Measure Type: Number
Unit of Measure: percentage of participants
25
Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Hide Arm/Group Description

Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.

Alemtuzumab: Given IV

Total-body irradiation: Undergo low-dose total-body irradiation

Fludarabine phosphate: Given IV

Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation

Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation

All-Cause Mortality
Dose Level 1 (No Campath) Dose Level 2 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
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 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      0/0      0/0    
Gastrointestinal disorders       
Abdominal pain   1/12 (8.33%)  1 0/0  0 0/0  0
Immune system disorders       
Death due to GVHD   1/12 (8.33%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  [1]  1/12 (8.33%)  1 0/0  0 0/0  0
Indicates events were collected by systematic assessment
[1]
Concurrent elevated bilirubin. Patient expired
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 (40mg Total Dose Campath) Dose Level 3 (60mg Total Dose Campath)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      0/0      0/0    
Blood and lymphatic system disorders       
Hemolysis   1/12 (8.33%)  1 0/0  0 0/0  0
Cardiac disorders       
Acute coronary syndrome   1/12 (8.33%)  2 0/0  0 0/0  0
Ventricular arrhythmia   1/12 (8.33%)  1 0/0  0 0/0  0
Investigations       
Blood bilirubin increased   4/12 (33.33%)  4 0/0  0 0/0  0
Creatinine increased   1/12 (8.33%)  1 0/0  0 0/0  0
Nervous system disorders       
Peripheral motor neuropathy   1/12 (8.33%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Hypoxia   1/12 (8.33%)  2 0/0  0 0/0  0
Vascular disorders       
Hypotension   1/12 (8.33%)  2 0/0  0 0/0  0
Indicates events were collected by systematic assessment
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: NCT00118352     History of Changes
Other Study ID Numbers: 1959.00
NCI-2009-01496 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1959.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P01CA018029 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: January 12, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017