SWOG clinical trial number
S0325
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Closed
Phase
Accrual
100%
Published
Research committees
Leukemia
Treatment
STI-571/Imatinib
Dasatinib
Eligibility Criteria Expand/Collapse
Pts must have a diagnosis of CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration. Pts must be registered within 180 days after first being diagnosed with CML, based on cytogenetic or molecular analysis demonstrating the presence of Philadelphia chromosomes or variants of the (9;22) translocation or testing positive for Bcr-Abl by RT-PCR. Pts may have had secondary chromosomal abnormalities in addition to the Philadelphia chromosome. Pts must have reached their 18th birthdays. Zubrod PS of 0-2. Pts must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Pts must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization. Pts must have a serum bilirubin, and SGOT/AST or SGPT/ALT< all less than or equal to 2.0 x the IULN within 14 days prior to registration. Pts (SWOG institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients." Pts (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary." Pts must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery. Pts must have an ECG within 42 days before registration and must not have the cardiac symptoms listed in Section 5.13. Pts must not have a history of significant bleeding disorder unrelated to cancer. 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, cervical carcinoma in situ, 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 five years.
Publication Information Expand/Collapse
2020
Bias in mean survival from fitting cure models with limited follow-up
PMid: PMID32828215 | PMC number: PMC7446760
2018
Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies
PMid: PMID29618479 | PMC number: PMC6014358
2014
2012
PMid: PMID22915637 | PMC number: PMC3496952
2010
A randomized phase II trial of dasatinib 100 mg vs. imatinib 400 mg in newly diagnosed chronic phase (CML-CP): the S0325 intergroup trial
Other Clinical Trials
SWOG Clinical Trial Number
S2507
A Phase II Randomized Study of Blinatumomab with or without Revumenib for Patients with KMT2A Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) with Persistent Measurable Residual Disease (MRD)
Research Committee(s)
Leukemia
Other
Activated
09/22/2026
Accrual
0%
Open
Phase
SWOG Clinical Trial Number
S2504
A Randomized Phase III Study of PIRtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously UntreateD RIchter TrAnsforMation (RT) (pirAMID)
Research Committee(s)
Leukemia
Lymphoma
Activated
06/01/2026
Accrual
2%
Open
Phase
SWOG Clinical Trial Number
CTSU/A042302
Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Research Committee(s)
Leukemia
Activated
03/06/2026
Open
Phase