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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002502
First received: November 1, 1999
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Procedure: allogeneic bone marrow transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: July 1992
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002502

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Esperanza B. Papadopoulos, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002502     History of Changes
Other Study ID Numbers: 92-103, CDR0000077927, NCI-H92-0143
Study First Received: November 1, 1999
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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
childhood Burkitt lymphoma
refractory multiple myeloma
Waldenström macroglobulinemia
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
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Plasmacytoma
Preleukemia
Syndrome
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Disease
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Pathologic Processes
Precancerous Conditions
Vascular Diseases
Busulfan
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on October 20, 2014