Idarubicin |
Idamycin |
Clinical Trial: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| relapsing chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia | Procedure: chemotherapy Procedure: biological response modifier therapy Procedure: interferon therapy Procedure: colony-stimulating factor therapy Procedure: peripheral blood stem cell transplantation Procedure: cytokine therapy Drug: graft versus tumor induction Drug: bone marrow ablation with stem cell support Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: filgrastim Drug: idarubicin Drug: interferon gamma | Phase I Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Intensive Idarubicin and Cytarabine Followed By High-Dose Conditioning Using Busulfan and Cyclophosphamide, Autologous Peripheral Blood Stem Cell Transplantation, and Graft Versus Leukemia Induction Using Cyclosporine and Interferon gamma in Patients With Chronic Myelogenous Leukemia in First Chronic Phase
Study start: February 1996
OBJECTIVES: I. Determine whether intensive idarubicin and cytarabine leads to adequate harvest of Philadelphia chromosome-negative peripheral blood stem cells (PBSC) in patients with chronic myelogenous leukemia in chronic phase. II. Determine the toxicity of this intensive regimen in these patients. III. Determine the graft-versus-leukemia effect induced in these patients by cyclosporine and interferon gamma post-PBSC transplantation. IV. Determine the transformation-free and overall survival in patients treated with a high-dose conditioning regimen comprising busulfan and cyclophosphamide followed by PBSC transplantation plus immunotherapy.
PROTOCOL OUTLINE: Patients receive idarubicin IV and cytarabine IV over 2 hours on days 1-3. When blood counts recover, Philadelphia chromosome negative peripheral blood stem cells (PBSC) are harvested. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning 24 hours after completion of cytarabine infusion and continuing until blood counts have recovered for 3 consecutive days after harvest of PBSC. Patients with more than 5% blasts in marrow or any peripheral blasts, interferon resistance, interferon intolerance with poor prognosis, and clonal evolution proceed to conditioning followed by PBSC transplantation. Patients receive conditioning comprising oral busulfan every 6 hrs on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. Patients receive graft versus leukemia induction comprising cyclosporine IV over 4 hours every 12 hours on days 0-28 and interferon gamma SC beginning on day 7 and continuing every other day through day 28. Patients are followed every 3 months for 1 year and then annually for 5 years.
PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 4-8 years.
Eligibility
Ages Eligible for Study: 18 Years - 60 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of chronic myelogenous leukemia in first chronic phase
- Philadelphia chromosome-positive
- Myelofibrosis less than 3+ on bone marrow biopsy
- Ineligible for allogeneic transplantation No suitable allogeneic sibling donor OR Under 55 years old but refuses unrelated donor transplantation or no unrelated donor available
--Prior/Concurrent Therapy--
- Biologic therapy: At least 4 weeks since prior interferon alfa
- Chemotherapy: No concurrent conventional chemotherapy
- Endocrine therapy: No concurrent steroids during chemotherapy
- Radiotherapy: Not specified
- Surgery: Not specified
- Other: No concurrent barbiturates or acetaminophen during chemotherapy
--Patient Characteristics--
- Age: 18 to physiologic 60
- Performance status: ECOG 0-1
- Hematopoietic: See Disease Characteristics; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
- Hepatic: Bilirubin less than 2 times normal (unless elevation due to Gilbert's disease); SGOT less than 1.5 times normal
- Renal: Creatinine less than 1.5 times normal
- Cardiovascular: Left ventricular ejection fraction at least 50%
- Pulmonary: DLCO at least 60% predicted
- Other: HIV negative
Location Information
Gwen Lucille Nichols, Study Chair, Herbert Irving Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002761
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Idamycin (Drug Digest)
- Idarubicin (Drug Digest)

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