| Last Verified: | September/30/2013 |
| First Submitted: | January/6/2009 |
| Estimated Enrollment Submitted: | January/6/2009 |
| First Posted: | January/7/2009 |
| Last Update Submitted: | October/27/2013 |
| Last Update Posted: | December/17/2013 |
| : | March/21/2013 |
| : | October/27/2013 |
| : | December/17/2013 |
| Actual Study Start Date: | April/30/2005 |
| Estimated Primary Completion Date: | February/28/2011 |
| Estimated Study Completion Date: | February/29/2012 |
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
| Study Type: | Interventional |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Arm | Intervention/treatment |
|---|---|
| Other: Hematopoietic Stem Cell Transplantation All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type | Biological: Hematopoietic Stem Cell Transplantation 43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9) |
| Ages Eligible for Study: | 40 Years to 40 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | - 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) |