Imatinib in combination with Cytarabine as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized phase III study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21778

Enrollment

330

Registered

2006-05-04

Start date

2006-05-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First chronic phase Chronic Myeloid Leukemia

Interventions

Patients meeting all eligibility criteria will be randomized between: Arm A: imatinib given orally at a total dose of 800 mg daily until progression

OR Arm B: imatinib given orally at a total dose of 800 mg daily, combined with 2 successive cycles of i.v. cytarabine 200 mg/m^2, at day 1-7, in cycles I and II, followed by imatinib monotherapy (800

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients with CML in first chronic phase <= 2 months; 2. Presence of Philadelphia chromosome or bcr-abl rearrangement; 3. Age 18-65 years inclusive; 4. WHO performance status <= 2; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. CML in accelerated phase or blastic crisis as defined by the WHO criteria; 2. Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N, and/or ASAT >= 4 x N); 3. Renal dysfunction (creatinine >= 200 micromol/l or 2.3 mg/dl); 4. Severe cardiac dysfunction (NYHA classification II-IV); 5. Severe pulmonary or neurologic disease; 6. Pregnant or lactating females; 7. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma; 8. Patients known to be HIV-positive; 9. Patients with active, uncontrolled infections; 10. Previous treatment other than hydroxyurea <= 2 months or imatinib <= 1 month; 11. Male and female patients of reproductive potential who are not practicing effective means of contraception.

Design outcomes

Primary

Measure	Time frame
Rate of major molecular response at 12 months from randomization.	—

Secondary

Measure	Time frame
1. Rate and duration of major and complete molecular response; 2. Rate and duration of major and complete cytogenetic response; 3. Rate and duration of complete hematological response; 4. Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first); 5. Overall survival measured from the time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive; 6. Toxicity; 7. Actual dose-intensity of imatinib delivered; 8. Incidence of mutations of abl-kinase domain.	—

Measure

Time frame

1. Rate and duration of major and complete molecular response; 2. Rate and duration of major and complete cytogenetic response; 3. Rate and duration of complete hematological response; 4. Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first); 5. Overall survival measured from the time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive; 6. Toxicity; 7. Actual dose-intensity of imatinib delivered; 8. Incidence of mutations of abl-kinase domain.

—

Contacts

Public ContactJ.J. Cornelissen

Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201

j.cornelissen@erasmusmc.nl+31 (0)10 4391598 or +31 (0)10 4391367

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)