SWOG clinical trial number
S1203
A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
Closed
Phase
Accrual
96%
Abbreviated Title
PIII 7+3 vs IA vs IA+vorinostat for AML
Status Notes
S1203 will permanently close to accrual on 11/4/15 at 11:59pm Pacific Time.
Activated
12/15/2012
Closed
11/04/2015
Participants
Research committees
Leukemia
Treatment
Cytosine Arabinoside
Daunomycin
Idarubicin HCL
Suberoylanilide Hydroxamic Acid (SAHA; Vorinostat)
Eligibility Criteria Expand/Collapse
-Morphologically confirmed newly diagnosed AML (by WHO criteria)
-APL, FAB, M3 or blastic transformation of CML NOT ELIGIBLE
-Pts with known CBF or FLT3 related leukemias are eligible, but should preferentially be placed on NCI-sponsored protocols specific for these subtypes, if available.
-Diagnostic/pre-treatment specimens obtained </= 28 days prior to reg submitted to local CLIA-approved laboratory for cytogenetic (and FISH if possible) analysis for risk status; karyograms and cytogenetics/FISH analysis reports must be submitted for discipline review
Must be chemo-naïve (no prior Induction chemo for AML or MDS; temp prior measures such as apheresis or hydroxyurea allowed)
-Prior anthracycline therapy is allowed (</=200 mg/m2 daunorubicin or equivalent)
-Pts with prior MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat.
-Pts must have blood/ marrow aspirate obtained </=28 days prior to reg submitted for TM (with patient consent, residuals will be banked)
->/= 18 and </=60 years of age
-Zubrod PS </=3
-ECHO or MUGA with ejection fraction >/= 45% </=28 days prior to reg
-No prolonged QTc interval (> 500 msec) by EKG </= 28 days prior to reg
-No cardiac disease (NYHA > Class II); no unstable angina (symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
-No coexisting medical condition that is likely to interfere with study procedures or results; must be reasonable candidates for intensive chemotherapy
-HIV+ pts must have following </=28 days prior to reg: CD4 cells ≥ 500/mm3; Viral load of < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if not on cART; No zidovudine or stavudine as part of cART
- Hepatitis B/C+ pts must have viral load < 800,000 IU/L </=28 days prior to reg
-Must be able to take oral meds
-Must not be pregnant or nursing; must agree to effective contraception
-Prior malignancy is allowed if it does not require concurrent therapy (Exception: Active hormonal therapy is allowed)
-Must not be receiving valproic acid.
-APL, FAB, M3 or blastic transformation of CML NOT ELIGIBLE
-Pts with known CBF or FLT3 related leukemias are eligible, but should preferentially be placed on NCI-sponsored protocols specific for these subtypes, if available.
-Diagnostic/pre-treatment specimens obtained </= 28 days prior to reg submitted to local CLIA-approved laboratory for cytogenetic (and FISH if possible) analysis for risk status; karyograms and cytogenetics/FISH analysis reports must be submitted for discipline review
Must be chemo-naïve (no prior Induction chemo for AML or MDS; temp prior measures such as apheresis or hydroxyurea allowed)
-Prior anthracycline therapy is allowed (</=200 mg/m2 daunorubicin or equivalent)
-Pts with prior MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat.
-Pts must have blood/ marrow aspirate obtained </=28 days prior to reg submitted for TM (with patient consent, residuals will be banked)
->/= 18 and </=60 years of age
-Zubrod PS </=3
-ECHO or MUGA with ejection fraction >/= 45% </=28 days prior to reg
-No prolonged QTc interval (> 500 msec) by EKG </= 28 days prior to reg
-No cardiac disease (NYHA > Class II); no unstable angina (symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
-No coexisting medical condition that is likely to interfere with study procedures or results; must be reasonable candidates for intensive chemotherapy
-HIV+ pts must have following </=28 days prior to reg: CD4 cells ≥ 500/mm3; Viral load of < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if not on cART; No zidovudine or stavudine as part of cART
- Hepatitis B/C+ pts must have viral load < 800,000 IU/L </=28 days prior to reg
-Must be able to take oral meds
-Must not be pregnant or nursing; must agree to effective contraception
-Prior malignancy is allowed if it does not require concurrent therapy (Exception: Active hormonal therapy is allowed)
-Must not be receiving valproic acid.
Publication Information Expand/Collapse
2024
PMid: PMID37935977
2023
PMid: PMID35833298 | PMC number: PMC9827148
2021
PMid: PMID3719833
PMid: PMID33560164 | PMC number: PMC8282671
2020
Rapid Donor Identification Improves Survival in High Risk First Remission AML Patients
PMid: PMID32048933 | PMC number: PMC7291544
Bias in mean survival from fitting cure models with limited follow-up
PMid: PMID32828215 | PMC number: PMC7446760
2019
PMid: PMID30315233 | PMC number: PMC6367002
PMid: PMID30315234 | PMC number: PMC6367029
Karyotype gender mismatch: a novel method of identifying transgender patients in large cohorts of patients with leukemia
2018
2016
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