Status:
COMPLETED
Fludarabine and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Lymphocytic Leukemia or Waldenstrom's Macroglobulinemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, ...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility and safety of induction therapy comprising fludarabine and cyclophosphamide followed by allogeneic stem cell transplantation in patients with high-ris...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia or lymphoplasmocytic lymphoma (Waldenstrom's macroglobulinemia)
- Must have poor prognostic features and low probability of successful autografting, defined by one of the following criteria:
- Progressive disease with unfavorable cytogenetics (deletion or mutation of critical regions on chromosomes 11q and/or 17p \[p53\]; and/or unmutated status of the immunoglobulin V\_H gene region; and/or usage of the V\_H 3-21 gene), defined as 1 of the following:
- Doubling of lymphocyte count or nodal involvement within 3 months or less
- Progressive decline of platelet count and/or hemoglobin values defining Binet stage C disease (or to 50% or less of baseline values within 3 months) not due to immune mechanisms
- Symptomatic splenomegaly
- Discomfort or imminent complications due to large tumor masses
- B symptoms
- Refractory disease or early relapse (within 12 months) after treatment with a fludarabine-containing regimen
- Relapsed after autologous stem cell transplant (SCT)
- Insufficient stem cell harvest for intended autologous SCT
- Presence of a clonal CDR III rearrangement detected by polymerase chain reaction
- No Richter's syndrome
- HLA-identical sibling or unrelated donor available
- PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 1
- Creatinine clearance \> 60 mL/min
- SGOT, SGPT, and bilirubin \< 2 times normal
- Normal cardiac function determined by ECG and echocardiographic examination
- Inspiratory vital capacity, FEV\_1, and DLCO \> 50% of predicted
- No serious localized or systemic infections
- No other concurrent malignant disease
- No impaired organ function
- No uncontrolled diabetes
- No uncontrolled hypertension
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No HIV infection
- No hepatitis B or C infection
- No concurrent alcohol or drug abuse
- No dementia or altered mental status that would preclude giving informed consent
- PRIOR CONCURRENT THERAPY:
- Not specified
Exclusion
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00281983
Start Date
June 1 2000
End Date
July 1 2010
Last Update
July 24 2017
Active Locations (13)
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1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
2
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12200
3
Universitaetsklinikum Essen
Essen, Germany, 45122
4
Universitaetsklinikum Goettingen
Göttingen, Germany, 37075