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
Abbreviated Title
Phase IIb Imatinib or Dasatinib for Untreated Chronic CML
Activated
08/15/2004
Closed
02/28/2009
Participants
NCORP, Members, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG

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

M Othus;A Bansal;H Erba;S Ramsey Value in Health Aug;23(8):1034-1039

PMid: PMID32828215 | PMC number: PMC7446760

2018

Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood Jun 21;131(25):2782-2788; Apr 4 [Epub ahead of print]

PMid: PMID29618479 | PMC number: PMC6014358

2016

Comparable outcomes of patients eligible versus ineligible for SWOG leukemia studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood 128:4002; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

2014

Imatinib 800 mg daily induces deeper molecular responses than imatinib 400 mg daily: results of SWOG S0325, an intergroup randomized phase II trial in newly diagnosed chronic phase chronic myeloid leukemia

M Deininger;K Kopecky;J Radich;S Kamel-Reid;W Stock;E Paietta;P Emanuel;M Wadleigh;R Larson;J Lipton;M Slovak;F Appelbaum;B Druker British Journal of Haematology 164(2):223-32;

PMid: PMID24383843 | PMC number: PMC4127316

2013

Alteration of cytogenetic risk stratification in new diagnosis of leukemia by FISH testing - the SWOG experience

M Fang;S McDonough;M Othus;L Zhuo;D Roulston;H Erba;F Appelbaum Blood 122:1383; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), poster;

2012

A randomized trial of dasatinib 100 mg vs imatinib 400 mg in newly diagnosed chronic phase chronic myeloid leukemia

J Radich;K Kopecky;F Appelbaum;S Kamel-Reid;W Stock;G Mainassy;E Paietta;M Wadleigh;R Larson;P Emmanuel;M Tallman;J Lipton;R Turner;B Druker Blood 120(19):3898-3905;

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

J Radich;K Kopecky;S Kamel-Reid;W Reid;E Paietta;R Larson;M Tallman;F Appelbaum;B Druker Blood 116:Abstract 6 (LBA-6); ASH late-breaking oral presentation