Status:
COMPLETED
Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops ...
Detailed Description
OBJECTIVES: Primary * Determine the safety of non-myeloablative allogeneic peripheral blood stem cell transplantation, in terms of regimen-related organ toxicity and toxicity from acute graft-vs-hos...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a high-risk indolent hematologic malignancy meeting the following criteria:
- Chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
- In second or subsequent remission
- Failed to achieve a complete remission (CR) after chemotherapy
- Non-Hodgkin's lymphoma (NHL) meeting 1 of the following criteria:
- Low-grade NHL meeting 1 of the following criteria:
- Standard-risk disease in second or subsequent remission
- Standard-risk disease and failed to achieve a CR after chemotherapy
- In first or subsequent remission with adverse International Prognostic Index (IPI) prognostic features, as defined by the presence of ≥ 3 of the following:
- Age \> 60 years
- Tumor stage III or IV
- Extranodal disease at \> 1 site
- ECOG performance status ≥ 2
- Serum lactic dehydrogenase (LDH) \> upper limit of normal (ULN)
- Intermediate- or high-grade NHL meeting 1 of the following criteria:
- In second or subsequent remission
- Failed to achieve a CR after initial chemotherapy
- Waldenstrom's macroglobulinemia meeting 1 of the following criteria:
- In second or subsequent remission
- Failed to achieve a CR after initial chemotherapy
- Multiple myeloma meeting 1 of the following criteria:
- In first or subsequent remission
- Failed to achieve a CR after initial chemotherapy
- Myeloproliferative disorders, including any of the following:
- Chronic myelogenous leukemia in first or subsequent chronic phase
- Myelofibrosis
- Essential thrombocytopenia that is poorly responsive to standard therapy
- Polycythemia vera that is poorly responsive to standard therapy or is in spent phase
- Prolymphocytic leukemia meeting 1 of the following criteria:
- In first or subsequent remission
- Failed to achieve a CR after initial chemotherapy
- Mantle cell lymphoma meeting 1 of the following criteria:
- In first or subsequent remission
- Failed to achieve a CR after initial chemotherapy
- Hodgkin's lymphoma meeting the following criteria:
- In second or subsequent remission
- Prior remission duration \> 6 months
- No radiation therapy as the only prior primary therapy
- Myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Any MDS with transfusion dependence
- Any MDS with ≥ 2 significant infections
- Acute myeloid leukemia in morphologic remission
- In CR or partial remission or stabilization of disease after standard chemotherapy
- No progressive or refractory disease
- Not eligible for standard allogeneic bone marrow transplantation
- Meets 1 of the following criteria:
- Age 60 to 75 years old AND no co-morbid illness
- Younger patients with any of the following comorbidities:
- Decreased cardiac ejection fraction
- Pulmonary dysfunction
- Elevated liver function tests
- Hepatitis C infection
- Poor performance status
- Sibling or related donor available
- Matched ≥ 5/6 HLA loci (A, B, and DR) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- PATIENT CHARACTERISTICS:
- See Disease Characteristics
- ECOG performance status 0-2
- Creatinine \< 2.0 mg/dL
- Creatinine clearance \> 40 mL/min
- Ejection fraction \> 30% by echocardiogram or MUGA
- Bilirubin \< 3.0 mg/dL (if total bilirubin is elevated and Gilbert's disease is suspected, direct bilirubin must be normal)
- Alkaline phosphatase \< 4 times ULN
- AST \< 4 times ULN
- HIV negative
- Hepatitis B and/or C virus allowed if a liver biopsy (performed within the past 3 months) shows ≤ grade 2 inflammation
- No active infection
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00296023
Start Date
January 1 1999
End Date
June 1 2008
Last Update
October 4 2012
Active Locations (2)
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1
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
2
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0324