Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Biological: recombinant interferon alfa Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: hydroxyurea Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase |
- Survival [ Designated as safety issue: No ]
- Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells [ Designated as safety issue: No ]
- Correlation of quality of hematological and cytogenetic remission with survival time [ Designated as safety issue: No ]
- Course of the terminal phase [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time [ Designated as safety issue: No ]
- Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 1997 |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia in chronic phase
- Previously untreated
Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:
- Impaired health status with reduced exercise tolerance
- Spleen-related symptoms in cases of splenomegaly
- Weight loss greater than 10% in 6 months
- Fever greater than 38.5 degrees C on 5 consecutive days
- Clinically relevant bone pain
- Leukocytosis greater than 5,000/mm^3
- Thrombocytosis greater than 100,000/mm^3
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy
- No severe concurrent disease or other cause that would preclude study
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior interferon
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Contacts and Locations
Show 188 Study Locations| Study Chair: | Ruediger Hehlmann, MD | III. Medizinische Klinik Mannheim |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00025402 History of Changes |
| Other Study ID Numbers: | CDR0000068957, III-MK-CML-3A, EU-20118 |
| Study First Received: | October 11, 2001 |
| Last Updated: | June 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
chronic phase chronic myelogenous leukemia chronic myelogenous leukemia, BCR-ABL1 positive Philadelphia chromosome negative chronic myelogenous leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia, BCR-ABL1 negative |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Interferon-alpha Interferon Alfa-2a Cytarabine Interferons Busulfan Cyclophosphamide Lenograstim |
Etoposide Hydroxyurea Idarubicin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 18, 2013