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Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)


N/A
18 Years
N/A
Open (Enrolling)
Both
Myeloid Leukemia, Chronic

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Trial Information

Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)


Principal Objective : To evaluate the complete molecular remission persistence after
stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts
in patients with Chronic Myeloid Leukemia .

Secondary Objective :

- To determine clinicals factors associated with complete molecular remission before and
after stopping imatinib in patients with Chronic Myeloid Leukemia.

- To determine the biologics factors (immunologic and molecular) associated with complete
molecular remission before and after stopping imatinib in patients with Chronic Myeloid
Leukaemia.

- To determine the molecular relapse level after more than six month of persistent
complete molecular remission without imatinib.

- To determine the complete molecular remission length.

- To evaluate medical and economical impact of stopping imatinib treatment.

Study design : multicentric trial


Inclusion Criteria:



- Patients must have reached their 18th birthday

- Women of childbearing potential must agree to use effective methods of contraception

- Patients must be affiliated to a social security regime

- Patients must have received imatinib therapy for at least 36 months.

- Patients must be in complete molecular remission during at least two consecutive
years with at least five RT-PCR negative measures for bcr-abl transcripts.

- Patients must be HIV, HCV and HBV negatives

- Patients who have molecular follow-up realized in accordance with international
recommendations

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent.

Exclusion Criteria:

- Patients who are protected by the law. Patients who are unable to give their consent
to participate to the study.

- Patients who have pathologies or treatments that are able to enhance the potential
relapse risk after stopping imatinib. Patients who have pathologies or treatments
which able to interfere with immunologic study (excepted IFN α):

Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by
chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts

Outcome Time Frame:

Every month during the first year and every two months during the second year

Safety Issue:

No

Principal Investigator

François-Xavier MAHON, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Bordeaux, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2006/06

NCT ID:

NCT00478985

Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Myeloid Leukemia, Chronic
  • Leukemia
  • Adult Chronic
  • Myeloid
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Chronic Disease

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