Status:
COMPLETED
Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers
Lead Sponsor:
University of California, Davis
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from reject...
Detailed Description
OUTLINE: * Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. * Allogeneic peripheral blood stem cell tra...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosed with any of the following:
- Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
- In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia
- Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
- CR1 with Philadelphia chromosome or poor-risk cytogenetics
- Chronic myelogenous leukemia (CML), meeting the following criteria:
- First or second chronic phase
- Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance
- Chronic lymphocytic leukemia (CLL), meeting the following criteria:
- Recurrent disease after fludarabine-based therapy
- Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy
- Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease\*), or transformed NHL, meeting 1 of the following criteria:
- Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
- Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu
- Recurrent multiple myeloma, meeting the following criteria:
- Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration
- Myelodysplastic syndrome
- Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
- Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria
- No RAEB II or del(5q)
- No uncontrolled CNS metastases
- 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available
- PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 50%
- Serum creatinine ≤ 2 mg/dL
- Not pregnant
- Fertile patients must use effective contraception
- 50 years of age or older
- Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
- Have a preexisting medical condition
- Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation
- Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
- No uncontrolled active infection
- No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
- Cardiac ejection fraction ≥ 30%
- Corrected pulmonary-diffusing capacity ≥ 35%
- No serologic evidence of infection with HIV
- No decompensated liver disease with serum bilirubin \> 2.0 mg/dL
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00619645
Start Date
June 1 2007
End Date
November 1 2013
Last Update
January 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis Cancer Center
Sacramento, California, United States, 95817