SWOG clinical trial number
S0333
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia with Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy
Closed
Phase
Accrual
100%
Research committees
Leukemia
Treatment
Cytosine Arabinoside
Cyclophosphamide
Prednisone
Dexamethasone
Vincristine
6-Mercaptopurine
6-Thioguanine
Allopurinol
Daunomycin
Doxorubicin
Filgrastim
Leucovorin Calcium
Methotrexate
Trimethoprim sulfa
PEG-L-Asparaginase
Mitoxantrone hydrochloride
Eligibility Criteria Expand/Collapse
Pts must have a morphologically confirmed diagnosis of ALL per protocol guidelines. Pts must not have Ph+ or BCR/ABL+ ALL. Pts must have reached their 18th birthday and not passed their 65th birthday. Zubrod PS 0-3. Pts must have received no prior remission induction chemotherapy for ALL. Pts may have received hydroxyurea to control the white blood cell count. Pts must have a serum creatinine less than or equal to 1.5 x IULN, or creatinine clearance greater than 60 cc/min, or both within 14 days prior to registration. Pts must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Must have either an ECG or MUGA scan with an ejection fraction >/= 50% within 28 days prior to reg. Pts must not have chronic liver disease or prior history of hepatitis B or C. Pts with abnormal LFTs > 5 x IULN must have negative hepatitis serology prior to reg. 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. Pts must be registered on SWOG-9007 and S9910. Pts must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
Publication Information Expand/Collapse
2018
Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies
PMid: PMID29618479 | PMC number: PMC6014358
2017
Next-generation sequencing in adult B cell acute lymphoblastic leukemia patients
PMid: PMID28062215 | PMC number: PMC5465962
2016
Genomic analyses identify recurrent MEF2D fusions in acute lymphoblastic leukaemia
PMid: PMID27824051 | PMC number: PMC5105166
2011
Outcome and incidence of hyperdiploidy and hypoploidy in adults with newly diagnosed acute lymphocytic leukemia
2010
Analysis of CRLF2/JAK expression and mutation status in adult ALL patients
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A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
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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