Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC # 648265, IND # 41121) Followed by Cytogenetic Risk-Adapted Intensification Therapy Followed by Immunotherapy With rIL-2 (NSC # 373364, IND # 1969) vs. Observation in Previously Untreated Patients With AML < 60 Years
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.
Status | Completed |
Enrollment | 720 |
Est. completion date | |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 59 Years |
Eligibility |
Inclusion Criteria: - Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French-American-British Cooperative group [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there was no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related MDS or therapy-related AML or a chronic myeloproliferative disorder are not eligible - No prior treatment for leukemia or myelodysplasia with four permissible exceptions: - Emergency leukapheresis - Emergency treatment for hyperleukocytosis with hydroxyurea - Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) - Growth factor/cytokine support |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer and Leukemia Group B | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival | An unstratified logrank test for the induction treatment comparison and a stratified logrank test for the post-remission treatment comparison will be the primary statistical methods used for treatment comparisons. | Up to 10 years | No |
Primary | Overall survival | An unstratified logrank test for the induction treatment comparison and a stratified logrank test for the post-remission treatment comparison will be the primary statistical methods used for treatment comparisons. | Up to 10 years | No |
Secondary | Estimates of disease-free survival curves | Up to 10 years | No | |
Secondary | Estimates of overall survival curves | Up to 10 years | No | |
Secondary | Toxicities and adverse events assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) | Will be tabulated. | Up to 10 years | Yes |
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