Status:
TERMINATED
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
Lead Sponsor:
Northside Hospital, Inc.
Collaborating Sponsors:
Blood and Marrow Transplant Group of Georgia
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
40-72 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cell...
Detailed Description
OBJECTIVES: * To evaluate the safety and toxicity of a reduced-intensity conditioning regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation from an HLA-matched unre...
Eligibility Criteria
Inclusion
- Diagnosis of one of the following hematological malignancies:
- CML, with 1 of the following:
- In first CP AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission at 3 months or a major cytogenetic response (i.e., Ph+ cells \< 35%) at 6 months or demonstrated clonal evolution or disease progression during therapy
- In accelerated phase with \< 15% blasts
- In blast crisis that has entered into a second CP following induction chemotherapy
- AML, with 1 of the following:
- In second or subsequent complete remission (CR) (i.e., \< 5% blasts by morphology, no residual leukemia by flow cytometry, and absence of cytogenetic abnormalities)
- Failed primary induction chemotherapy, but subsequently entered into a CR with ≤ 2 subsequent re-induction chemotherapy treatment(s)
- In first CR with intermediate-risk or poor-risk cytogenetics
- ALL with 1 of the following:
- In second or subsequent CR
- In first CR AND presence of t(9;22)
- MDS, with the following:
- High-risk disease, defined by IPSS score of ≥ 1.5 at diagnosis AND meets 1 of the following criteria:
- ≤ 10% blasts at diagnosis
- In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy
- CMML, with 1 of the following:
- ≤ 10% blasts at diagnosis
- In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy
- CLL/PLL with the following:
- Rai stage I-IV disease
- Failed ≥ 1 prior chemotherapy regimen (including fludarabine phosphate) or ASCT
- Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter
- No bulky tumor masses, elevated lactate dehydrogenase (LDH), B symptoms, or progressive disease prior to transplant
- Low-grade non-Hodgkin lymphoma (NHL) (i.e., small lymphocytic lymphoma, follicular center lymphoma \[grade 1 or 2\], marginal zone lymphoma, or B-cell lymphoma), with the following criteria:
- Failed ≥ 1 prior chemotherapy regimen or ASCT
- Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter
- Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered a prior regimen)
- No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
- Mantle cell lymphoma, with the following:
- Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
- Responsive or stable disease to most recent prior therapy
- No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
- Intermediate-grade NHL (i.e., follicular center lymphoma \[grade 3\] or diffuse large cell lymphoma), meeting the following criteria:
- Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
- Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
- No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
- Hodgkin lymphoma, with the following:
- Relapsed after prior ASCT OR after ≥ 2 combination chemotherapy regimens and ineligible for ASCT
- Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
- No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
- Peripheral T-cell NHL, with the following:
- Failed to achieve remission or recurred after either conventional chemotherapy or ASCT
- Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites)
- No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant
- Myeloproliferative syndrome with poor risk features, meeting 1 of the following criteria:
- \< 55 years old AND Lille score of 1
- Lille score of 2
- HgB \< 10 g/dL AND abnormal karyotype
- High-risk disease, with 1 of the following:
- Age 40-72 years
- Any age AND deemed to be at significantly increased risk of morbidity and death following a standard, myeloablative unrelated donor stem cell transplant (e.g., received extensive prior therapy, including ASCT)
- HLA-matched unrelated donor available, with 1 of the following:
- 8/8 match at HLA-A, B, C, or DR loci by high-resolution genotyping
- Single allelic mismatch at either the HLA-B or HLA-C loci donor by high-resolution molecular typing
- No single allelic mismatch at HLA-A or HLA-DR loci
- KPS 80-100%
- Adapted weighted Charlson Comorbidity Index \< 3
- Serum creatinine ≤ 2.0 mg/dL
- AST or ALT \< 3 times upper limit of normal (ULN)
- Total bilirubin \< 1.5 times ULN
- LVEF ≥ 45%
- DLCO \> 50%
- No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy)
- No other severe pulmonary function abnormalities
- No HIV infection
- No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate to high risk for developing severe hepatic disease
- No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00818961
Start Date
May 1 2005
End Date
March 1 2012
Last Update
December 18 2013
Active Locations (1)
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1
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342