Overview

Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML

Status:
Active, not recruiting

Trial end date:
2021-10-01

Target enrollment:

Participant gender:

Summary

This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with individual therapeutic benefit aim: Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML) The primary objective of the study is to compare between the two arms Event-free Survival (EFS). Secondary objectives are to compare between both arms: Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3 and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity (hematological and non hematological) Prognostic factors

Phase:

Phase 3

Details

Lead Sponsor:

Groupe Francophone des Myelodysplasies

Collaborator:

Janssen-Cilag Ltd.

Treatments:

Allopurinol
Azacitidine
Benzocaine
Decitabine
Hydroxyurea