Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)

Stopped early · Phase 3

Conditions studied: Leukemia, Myeloid, Chronic Phase

In brief

This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Key facts

Study ID: NCT00124748
Run by: Novartis Pharmaceuticals
People needed: 476
Starts: 2005-06-01
Expected to finish: 2010-11-01
Last updated by the study team: 2012-02-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis)
Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)
Documented chronic phase CML
Adequate end organ function as defined by:
total bilirubin < 1.5 x Upper Limit of Normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN
creatinine < 1.5 x ULN

You may not qualify if…

Patients in late chronic phase, accelerated phase, or blastic phase are excluded
Patients who have received other investigational agents
Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTI571A2107 (NCT00428909)] study immediately prior to the participation in this study
Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)
Patient previously received radiotherapy to ≥ 25% of the bone marrow
Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3
Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
Other protocol-defined inclusion/exclusion criteria applied.

Where it is running

Alta Bates Comprehsenive Cancer Center — Berkeley, California, United States
University of Miami — Berkeley, California, United States
South Bay Oncology Hematology Partners — Campbell, California, United States
UCLA Medical Center — Los Angeles, California, United States
Rocky Mountain Cancer Center — Denver, Colorado, United States
Osler Medical Inc. — Melbourne, Florida, United States
Advanced Medical Specialists — Miami, Florida, United States
Integrated Community Oncology Network — Orange Park, Florida, United States
Hematology-Oncology Associates, P.A. — Pensacola, Florida, United States
Palm Beach Cancer Institute — West Palm Beach, Florida, United States
Palm Beach Cancer Institute — West Palm Beach, Florida, United States
Cancer Research Center of Hawaii — Honolulu, Hawaii, United States
Rush University Medical Center — Chicago, Illinois, United States
Indiana Blood and Marrow Institutw — Beech Grove, Indiana, United States
Indiana Blood and Marrow Transplant — Beech Grove, Indiana, United States
University of Iowa Hospitals & Clinic — Iowa City, Iowa, United States
University of Kentucky - C201 Clinic — Lexington, Kentucky, United States
University of Kentucky — Lexington, Kentucky, United States
Lousville Oncology, Clinical Research Program M-25 — Louisville, Kentucky, United States
Jayne S. Gurtler, MD, Laura A. Brinz, MD & Angelo Russo, MD — Metairie, Louisiana, United States
Hematology and Oncology Specialists — New Orleans, Louisiana, United States
LSU Health Science Center — Shreveport, Louisiana, United States
LSU Health Scine Center — Shreveport, Louisiana, United States
St. Agnes Hospital — Baltimore, Maryland, United States
University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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