Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Drug: methylprednisolone Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: syngeneic bone marrow transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation |
- Hematopoietic recovery [ Designated as safety issue: No ]
- Incidence of graft-versus-host disease [ Designated as safety issue: No ]
- Chemotherapeutic toxicity [ Designated as safety issue: Yes ]
- Relapse and survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | April 1998 |
OBJECTIVES:
- Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation.
- Determine the chemotherapeutic toxicity of this regimen in these patients.
- Determine the relapse and survival of patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in patients treated with this regimen.
OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation.
Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.
Eligibility| Ages Eligible for Study: | 1 Year to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically and/or histologically confirmed hematologic malignancy or genetic disorder
Chronic myelogenous leukemia
- Typical blood and marrow morphology
- Presence of Philadelphia chromosome OR
- Molecular evidence of bcr/abl rearrangement if Philadelphia chromosome-negative
Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma
- High risk of relapse or progressive disease
- Typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
Multiple myeloma
- Typical marrow morphology, radiographic findings, and paraprotein
Aplastic anemia
- Typical marrow and blood findings
- Genetic disorder including storage disease (e.g., adrenoleukodystrophy), hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency
- Unwilling to undergo conventional high-dose chemoradiotherapeutic conditioning prior to allogeneic stem cell transplantation OR
- Presence of other medical disorder which precludes high-dose chemoradiotherapeutic conditioning (e.g., cardiac disease or infection)
- Syngeneic twin, HLA-identical, or 1 or 2 HLA antigen-mismatched family member or unrelated donor
PATIENT CHARACTERISTICS:
Age:
- 1 to 80
Performance status:
- Karnofsky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other serious medical or psychiatric illness that would preclude study compliance
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Study Chair: | David G. Savage, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008307 History of Changes |
| Other Study ID Numbers: | CDR0000068396, CPMC-IRB-8462, CPMC-IRB-CAMP-25, NCI-G00-1897 |
| Study First Received: | January 6, 2001 |
| Last Updated: | June 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Antilymphocyte Serum Cyclosporins Cyclosporine Melphalan Mycophenolate mofetil Fludarabine monophosphate |
ClinicalTrials.gov processed this record on May 16, 2013