Status:

UNKNOWN

Tolerance and Efficacy of Subcutanous Low Doses Rituximab for CLL Consolidation Treatment

Lead Sponsor:

Institut Paoli-Calmettes

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances have established correlation between the quality of the response (in particular achievement of negativity of m...

Detailed Description

Objective(s) of the clinical study Main objective: \- To improve the minimal residual disease (MRD) negative complete response (CR) rate after consolidation using subcutaneous low dose of rituximab ...

Eligibility Criteria

Inclusion

  • CLL (Matutes 4 or 5) in CR after induction treatment with negative MRD or PR
  • age\>18
  • performance status\<=2
  • signed informed consent

Exclusion

  • cytopenia
  • other malignant affection
  • HIV or HBV positive
  • steroids treatment
  • richter syndrome
  • pregnant or breastfeeding women

Key Trial Info

Start Date :

December 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2015

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT01521689

Start Date

December 1 2011

End Date

June 1 2015

Last Update

March 20 2015

Active Locations (1)

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1

Institut Paoli Calmettes

Marseille, France, 13009