A RANDOMIZED PHASE II STUDY COMPARING IMATINIB AND THE COMBINATION OF IMATINIB AND PEGYLATED INTERFERON ALPHA-2B IN NEWLY DIAGNOSED NON-HIGH RISK CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE HEMATOLOGICAL REMISSION AFTER IMATINIB INDUCTION THERAPY - Nordic IR-LR Study
- Conditions
- ewly diagnosed chronic myeloid leukemia (CML) belonging to intermedia (IR) or low risk (LR) by the Sokal prognostic score
- Registration Number
- EUCTR2004-002504-15-FI
- Lead Sponsor
- The Nordic CML Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
1. At least CHR after three months treatment with Imatinib 400 mg/day.
2. Age =18 years
3. CP1 of less than 6 months duration
4. Sokal IR/LR
5. Performance status (ECOG) =2
6. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Less than CHR after 3 months Imatinib treatment.
2. Age <18
3. Sokal HR
4. More than 6 months from diagnosis.
5. CP2 or ABP
6. Scheduled alloSCT within 1 year from diagnosis.
7. Performance status (ECOG) >2
8. Inability to provide written informed consent
9. Pregnancy
10. Formal refusal of any recommendation of a safe contraception
11. Alcohol or drug addiction
12. Altered hepatic or renal function as defined by ASAT/ALAT or bilirubin > 3 times upper normal limits (UNL) and by creatinine >20mg/L (177 µmol/L)
13. Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
14. Participating in another treatment trial.
15. Pretreatment with chemotherapy other than HU and agrylin.
16. Secondary malignancy if it requires therapy and estimated life expectancy is shorter than median survival of CML.
17. Other serious diseases, pregnancy including lactation period or other conditions which could prevent the required protocol compliance.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare in Sokal IR/LR CML patients, pretreated with Imatinib for 3 months to CHR, the rate of at least a 3 log reduction in tumor burden (measured with qPCR), after 12 months treatment with imatinib 400 mg daily or imatinib 400 mg daily combined to Peg-IFN 50 µg weekly;Secondary Objective: 1)The rate of 4 log reduction<br>2)The mean level of minimal residual disease, expressed as K562 equivalents<br>3)The duration of hematological, cytogenetic and molecular response<br>4)The rate of molecular progression<br>5)The timing of molecular response<br>6)The rate of CCgR<br>7)The time to ABP <br>8)The overall survival<br>9)The safety and tolerability of the treatment.<br>;Primary end point(s): The rate of at least a 3 log reduction in tumor burden (measured with qPCR), after 12 months treatment with imatinib 400 mg daily or imatinib 400 mg daily combined to Peg-IFN 50 µg weekly
- Secondary Outcome Measures
Name Time Method