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Search / Trial NCT00002567

High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · May 21, 2004

Trial Information

Current as of March 19, 2025

Completed

Keywords

Adult Acute Myeloid Leukemia In Remission Adult Acute Lymphoblastic Leukemia In Remission Adult Acute Erythroid Leukemia (M6) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Promyelocytic Leukemia (M3) Adult Acute Myelomonocytic Leukemia (M4) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Monocytic Leukemia (M5b) Bone Marrow Ablation Adult Acute Minimally Differentiated Myeloid Leukemia (M0)

ClinConnect Summary

OBJECTIVES: I. Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell (PBSC) transplantation in prolonging the disease-free survival of patients with acute leukemia. II. Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy.

OUTLINE: Patients are treated on Regimen A, then Regimen B. Regimen A: Stem Cell Mobilization. Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Radiotherapy and Myeloablative Chemotherapy with Hematopo...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Previously diagnosed acute leukemia in one of the following categories: Acute myelogenous leukemia (any subtype) in first or subsequent remission Ph+ acute lymphoblastic leukemia (ALL) in first or greater remission Ph- ALL in second or subsequent remission Cellular marrow with no morphologic evidence of residual leukemia within approximately 2 weeks of cryopreservation Negative CSF cytology required of ALL patients Allogeneic marrow transplant considered for patients under age 55 with a healthy HLA-identical family member available
  • PATIENT CHARACTERISTICS: Age: Over 16 to 65 Performance status: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dl Renal: Creatinine no greater than 1.5 mg/dl OR Creatinine clearance at least 60 ml/min Cardiovascular: LVEF at least 50% by MUGA or normal on echocardiogram Pulmonary: DLCO at least 50% of predicted Other: HIV seronegative No uncontrolled infection Negative pregnancy test required of fertile women
  • PRIOR CONCURRENT THERAPY: See Disease Characteristics

Trial Officials

Peter Maslak, MD

Study Chair

Memorial Sloan Kettering Cancer Center

About Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.

Locations

New York, New York, United States

People applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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