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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00040846
First received: July 8, 2002
Last updated: March 24, 2017
Last verified: March 2017
Results First Received: January 26, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dose Level 1 (No Campath)

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

Dose Level 2 (0.025 mg/kg/Day Campath)

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

Dose Level 3 (0.050 mg/kg/Day Campath)

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

Dose Level 4 (0.10 mg/kg/Day Campath)

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

Dose Level 5 (0.20 mg/kg/Day Campath)

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

Dose Level 6 (0.40 mg/kg/Day Campath)

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


Participant Flow:   Overall Study
    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)
STARTED   60   0   0   0   0   0 
COMPLETED   60   0   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dose Level 1 (No Campath)

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

Dose Level 2 (0.025 mg/kg/Day Campath)

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

Dose Level 3 (0.050 mg/kg/Day Campath)

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

Dose Level 4 (0.10 mg/kg/Day Campath)

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

Dose Level 5 (0.20 mg/kg/Day Campath)

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

Dose Level 6 (0.40 mg/kg/Day Campath)

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 60   0   0   0   0   0   60 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Full Range)
 56.7 
 (13 to 72) 
                56.7 
 (13 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      15  25.0%                     15  25.0% 
Male      45  75.0%                     45  75.0% 
Region of Enrollment 
[Units: Participants]
             
United States   60                  60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evaluate the Risk of Transplant Related Mortality.   [ Time Frame: 100 days after transplant ]

2.  Primary:   Evaluate the Risk of Occurrence of Acute and Chronic GVHD   [ Time Frame: 1 year after transplant ]

3.  Primary:   Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.   [ Time Frame: 100 days after transplant ]

4.  Secondary:   Evaluate the Risk/Incidence of Infections   [ Time Frame: 100 days after transplant ]

5.  Secondary:   Evaluate the Risk for Disease Progression and Relapse   [ Time Frame: 1 year after transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Brenda M. Sandmaier
Organization: Fred Hutchinson Cancer Research Center
phone: (206) 667-4961
e-mail: bsandmai@fhcrc.org


Publications of Results:

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 )
Study First Received: July 8, 2002
Results First Received: January 26, 2017
Last Updated: March 24, 2017