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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896842
Other study ID # 09/38_ Optim Imatinib
Secondary ID
Status Completed
Phase Phase 2
First received September 7, 2016
Last updated November 21, 2017
Start date September 2010
Est. completion date December 2016

Study information

Verified date November 2017
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date December 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patient = 18 years

2. Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (= 4 months) in first chronic phase.

3. Not previously treated with tyrosine kinase inhibitors other than imatinib

4. Prior treatment with imatinib during less than 13 weeks

5. Signed written inform consent

6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception

Exclusion Criteria:

1. Patients with BCR-ABL positive, Philadelphia negative CML

2. Patient previously treated with TKI other than imatinib

3. Pregnancy

4. Active malignancy

5. Concurrent severe diseases which exclude the administration of therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Posology dose modification

Other:
active comparator


Locations

Country Name City State
France CHU angers Angers
France CH d'Annecy Annecy
France CH argenteuil Argenteuil
France CHU Bordeaux Bordeaux
France Institut Bergonié Bordeaux
France CH Boulogne Boulogne
France CHU CAEN Caen
France CH de Dieppe Dieppe
France CH Dunkerque Dunkerque
France CH Versailles Le Chesnay
France CHU Lille Lille
France CHU Lyon Lyon
France CH Meaux Meaux
France Hopital Bon secours Metz
France CHU Nice Nice
France Hopital La Source Orléans La Source
France Hopital Necker Paris
France CHU Rennes Rennes
France Hopital Purpan Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The major molecular response rate at 12 months in cohort 1. 12 months
Secondary Complete cytogenetic response at 6 and 12 months 12 months
Secondary Major molecular response rate at 12 months in cohort 2 and cohort 3. 12 months
Secondary Major molecular response at 3, 6, and 9 months 9 months
Secondary Complete molecular response 6 and 12 months 12 months
Secondary Relationship between plasmatic dosage and efficacy 12 months
Secondary Relationship between plasmatic dosage and tolerance 12 months
Secondary Progression free survival 5 years
Secondary Event free survival 5 years
Secondary Overall survival 5 years
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