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Completed

NCT Number: NCT00002502

Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute or chronic leukemia or myelodysplastic syndrome.

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Key information

Conditions

Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Blast Crisis Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

OBJECTIVES: I. Determine the effect of marrow ablation with high dose busulfan/cyclophosphamide on engraftment, incidence of posttransplant relapse, incidence and severity of graft versus host disease (GVHD), and incidence and severity of nonGVHD posttransplant complications in patients with acute or chronic leukemia or myelodysplastic syndrome who are eligible for allogeneic bone marrow transplants from HLA identical/compatible donors but who cannot or should not receive total body irradiation as part of their cytoreductive regimen.

OUTLINE: 2-Drug Combination Cytoreductive Chemotherapy followed by Bone Marrow Transplant with, as indicated, CNS Prophylaxis. Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed by Allogeneic Bone Marrow, AlBM; with, as indicated, Intrathecal Cytarabine, IT ARA-C, NSC-63878.

PROJECTED ACCRUAL: At least 15 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Primary or secondary acute nonlymphocytic leukemia and acute lymphocytic leukemia in one of the following states: First or greater remission Early relapse Chronic myelogenous leukemia (CML) in one of the following states: First or greater chronic phase Treatment on this protocol is preferred to total body irradiation containing protocols for patients under 40 with CML in stable first chronic phase who are otherwise eligible for allogeneic bone marrow transplantation Accelerated phase Myeloid or lymphoid blast crisis Myelodysplastic syndromes of the following types: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Chronic myelomonocytic leukemia Multiple myeloma Non-Hodgkin's lymphoma HLA identical bone marrow donor available Unable to undergo total body irradiation because of one of the following reasons: Under age 2 (CNS still growing and at high risk of permanent radiation injury) Prior high dose radiotherapy to the brain, lungs, heart, liver, or abdomen In relapse following allogeneic or autologous transplant using total body irradiation for ablation, but eligible for a second transplant No current CNS involvement

PATIENT CHARACTERISTICS: Age: 50 and under (patients aged 51-55 accrued on a case-by-case basis after discussion and approval by the BMT service) Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL AST no greater than 3 times normal Neither value increasing for at least 2-4 weeks prior to transplant Renal: Creatinine less than 2 times normal and not rising for at least 2-4 weeks prior to transplant OR Creatinine clearance greater than 80 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% Cardiac function good Pulmonary: No severe restrictive lung disease No chronic obstructive pulmonary disease Other: No active viral or bacterial infection at transplant No coexisting medical problem that would significantly increase the risk of the transplant procedure Not pregnant

PRIOR CONCURRENT THERAPY: Prior therapy allowed, including prior bone marrow transplant

Treatment and study plan

busulfan

Drug

Cyclophosphamide

Drug

Cytarabine

Drug

allogeneic bone marrow transplantation

Procedure

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

BUSULFAN AND CYCLOPHOSPHAMIDE FOR CYTOREDUCTION OF PATIENTS WITH ACUTE AND CHRONIC LEUKEMIAS AND MYELODYSPLASTIC SYNDROMES UNDERGOING ALLOGENEIC BONE MARROW TRANSPLANTATION WHO CANNOT BE TREATED WITH TOTAL BODY IRRADIATION

Important dates

Study start
1992
Primary completion
2000
Study completion
2000
First posted
Jul 19, 2004
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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