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Gottlieb Memorial Hospital

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NCT00004905

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Acute Leukemia

Official Title:

Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia

Summary

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

PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or acute leukemia.

Eligibility

DISEASE CHARACTERISTICS: One of the following hematologic conditions: Chronic phase or advanced chronic myelogenous leukemia Acute lymphoblastic leukemia: -relapsed -in second remission or later -in first remission with unfavorable prognostic features Acute myelogenous leukemia: -in second remission or later -in first remission with high-risk features Detectable clonal cytogenetic or molecular abnormality at time of diagnosis Not eligible for allogenic bone marrow transplant

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction greater than 45% Pulmonary: DLCO greater than 60% FEV1 greater than 60% Other: No serious underlying medical condition that would preclude study Not pregnant or nursing No cerebellar dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description:
    • Arm Group Labels:
    • Type: BIOLOGICAL
    • Name: recombinant interferon alfa
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: cyclophosphamide
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: cytarabine
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: etoposide
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: idarubicin
    • Description:
    • Arm Group Labels:
    • Type: PROCEDURE
    • Name: peripheral blood stem cell transplantation
    • Description:
    • Arm Group Labels:
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels:
Sponsor
  • Loyola University