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PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS


Phase 2
16 Years
65 Years
Not Enrolling
Both
Bone Marrow Ablation, Leukemia

Thank you

Trial Information

PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS


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 Hematopoietic Rescue. Total-Body
Irradiation, TBI (high-energy electrons used for lung boost); and Etoposide, VP-16,
NSC-141540; with Peripheral Blood Stem Cells, PBSC; G-CSF.

PROJECTED ACCRUAL: Up to 45 patients will be studied over approximately 3 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter Maslak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

93-161

NCT ID:

NCT00002567

Start Date:

March 1994

Completion Date:

November 2000

Related Keywords:

  • Bone Marrow Ablation
  • Leukemia
  • 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)
  • Leukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021