Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
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Purpose
RATIONALE: Giving chemotherapy and total-body irradiation 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. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Malignant Plasma Cell Neoplasms Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms |
Drug: cyclophosphamide Radiation: TBI |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors |
- event free survival (EFS) [ Time Frame: five year post transplant ] [ Designated as safety issue: No ]EFS determined by the Kaplan-Meier product limit method
- Incidence of graft versus host disease [ Time Frame: five years post transplant ] [ Designated as safety issue: No ]incidence and severity of acute and chronic GVHD
| Enrollment: | 72 |
| Study Start Date: | May 1996 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cy/TBI
cyclophosphamide and total body irradiation (TBI)
|
Drug: cyclophosphamide
Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)
Radiation: TBI
FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
|
Detailed Description:
OBJECTIVES:
- Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
- Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Eligibility| Ages Eligible for Study: | 15 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Acute lymphocytic leukemia (ALL):
- Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
Acute myelogenous leukemia (AML):
- CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
Chronic myelogenous leukemia (CML):
- Chronic phase (CP) 1
- Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant
Chronic lymphocytic leukemia (CLL):
- Relapse - any stage; must have received no more than 3 prior regimens
Multiple myeloma:
- At diagnosis - primary refractory
- Relapse (no more than 2) - sensitive disease
- Plasma cell leukemia
- Inability to achieve a complete remission after autologous transplant (no older than 40)
- Myelodysplasia - all subtypes
- Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities
Severe aplastic anemia (SAA):
- Very SAA - at diagnosis
- SAA - induction therapy
- Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
- 15 to 50
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 3 times normal
- PT/PTT normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction at least 45%
- No myocardial infarction within past 6 months
- No uncontrolled arrhythmias
Pulmonary:
- FEV1 at least 50%
- DLCO at least 50% predicted
Other:
- No active serious infection
- HIV negative
- Not pregnant or nursing
- No uncontrolled diabetes mellitus or thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, Florida | |
| Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612-9497 | |
| Study Chair: | Teresa Field, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00005622 History of Changes |
| Other Study ID Numbers: | MCC-11282, IRB-4189, NCI-G00-1755 |
| Study First Received: | May 2, 2000 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
recurrent childhood acute lymphoblastic leukemia refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia |
blastic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission polycythemia vera primary myelofibrosis essential thrombocythemia refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Precancerous Conditions Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 19, 2013