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Leukemia

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

Unique Dataset IDLeukemi_Allianc_2000_220
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients720Comparator (Control) Arm Enrolled Patients151Experimental (Active) Arm Enrolled Patients151RandomizationYesClinicalTrial.gov IDNCT00006363ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/record/NCT00006363?term=CALGB+19808&rank=2
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeSurgery, Biologics, DrugDataset TypeADS

Clinical Trial 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

Trial Summary and Conditions

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.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics, etc. See the data dictionary provided for more details.

Study Objectives

Primary: To determine whether the addition of PSC-833 to induction chemotherapy improves disease-free survival and overall survival for patients with AML < 60 years. To determine whether post-consolidation immunotherapy with low-dose continuous/intermittent high-dose bolus subcutaneous rIL-2 improves disease-free survival and overall survival in patients with AML < 60 years in first CR. Secondary: To continue to evaluate the effectiveness of three courses of HiDAC as curative consolidation chemotherapy in patients with CBF leukemias. To continue to establish the use of intensive post-remission chemotherapy with PSCT or a novel intensification sequence consisting of HiDAC/high dose etoposide/G-CSF followed by two cycles of HiDAC in patients in CR with unfavorable cytogenetics. To correlate the rate of relapse and toxicity with busulfan pharmacokinetics when busulfan and etoposide are used prior to autologous stem cell transplantation for AML patients in first CR.

Outcome Measures

Primary Outcome Measures: Disease-free survival [ Time Frame: Up to 10 years ] 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. Overall survival [ Time Frame: Up to 10 years ] 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. Secondary Outcome Measures: Estimates of disease-free survival curves [ Time Frame: Up to 10 years ] Estimates of overall survival curves [ Time Frame: Up to 10 years ] Toxicities and adverse events assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 10 years ]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 19808-11.pdf

CRF: 19808_CRFs.pdf

DATA DICTIONARY: 19808_datasphere.docx

DATA (ACTIVE ARM): analysis.sas7bdat

DATA (ACTIVE ARM): ae.sas7bdat