SWOG clinical trial number
S0301
A Phase II Study of Induction With Daunorubicin, Cytarabine, and Cyclosporine All By Continuous IV Infusion for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older.
Closed
Phase
Accrual
100%
Published
Research committees
Leukemia
Treatment
Cytosine Arabinoside
Cyclosporine
Daunomycin
Filgrastim
GM-CSF
Eligibility Criteria Expand/Collapse
Initial Registration: Pts must have a morphologically confirmed diagnosis of AML with FAB classification other than M3, based on bone marrow and biopsy performed within 14 days prior to registration. Pts with M3 AML or blastic transformation of CML are not eligible. Pts must have reached their 56th birthday. Pts must have a Zubrod PS of 0-3 if less than age 61, Zubrod PS of 0-2 if age 61-70, and Zubrod PS of 0-1 if age 71 or older. Pts must have a bilirubin less than or equal to 2 x IULN, within 7 days prior to this registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, and not to liver dysfunction. Pts must also have SGOT (AST) less than or equal to 4 x IULN, or SGPT (ALT) less than or equal to 4 x IULN, within 7 days prior to this registration. Serum creatinine less than or equal to 1.5 x IULN or a creatinine clearance greater than 40 cc/min, or both. Pts must have a normal left ventricular function with an ejection fraction greater than or equal to 50% as measured by MUGA scan or 2-D ECHO. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not have received prior systemic chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted. A history of prior treatment of MDS with low dose cytosine arabinoside or with azacitidine is permitted; however, 30 days must have elapsed from prior treatment and all toxicities resolved. If indicated, a single dose of intrathecal chemotherapy may also be given before or concurrent with induction chemotherapy. Pts must be registered on SWOG-9007 and on S9910. Pts must agree to submit blood and plasma for PK studies per the protocol. Pts must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 years.
Publication Information Expand/Collapse
2018
Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies
PMid: PMID29618479 | PMC number: PMC6014358
2015
PMid: PMID25884949 | PMC number: PMCID4401549
Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia
PMid: PMID25527568 | PMC number: PMC4349271
2013
2010
Sequential phase II Southwest Oncology Group studies (S0112 and S0301) of daunorubicin and cytarabine by continuous infusion, without and with cyclosporine, in older patients with previously untreated acute myeloid leukemia (AML) [PMID 19821823; PMC2967366]
Other Clinical Trials
SWOG Clinical Trial Number
CTSU/A042001
A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
Research Committee(s)
Leukemia
Activated
02/27/2023
Open
Phase
SWOG Clinical Trial Number
S1925
A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Research Committee(s)
Leukemia
Lymphoma
Symptom Control and Quality of Life
Activated
12/14/2020
Accrual
49%
Open
Phase
SWOG Clinical Trial Number
CTSU/AALL1821
A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination with Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old with First Relapse
Research Committee(s)
Leukemia
Activated
12/04/2020
Open