Status:
COMPLETED
Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 wi...
Detailed Description
ARM A: DECITABINE (DAC) Decitabine (DAC) will be administered at 20 mg/m2 intravenously daily for 5 days every 28 days. Treatment will be delayed at the discretion of the investigator (up to D56) fo...
Eligibility Criteria
Inclusion
- Age ≥ 18
- CMML diagnosis according to WHO criteria Stable excess in blood monocytes, \> 1 G/L Lack of bcr-abl rearrangement (or Philadelphia chromosome) Bone marrow blast cells \< 20% Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation Blood and marrow smears will be reviewed at each country's level, but morphologist meetings at the 3 country level are planned for better harmonization and review of difficult cases
- WBC ≥ 13 G/L Measured on two successive CBC at least two weeks apart, outside of a context of infection.
- Either D1 or D2
- D1: At least two of the following criteria, reviewed at each country's level: (modified from Wattel et al. Blood 1996) Marrow blasts \>= 5 % Clonal cytogenetic abnormality (other than t(5;12) (q33; p13) and isolated loss of Y chromosome ) Anemia (Hb \< 10 g/dL) ANC \> 16 G/l (in absence of infection) Thrombocytopenia (platelet count \< 100 G/L) Splenomegaly \> 5 cm below costal margin (spleen size should also be measured by an imaging technique)
- Or:
- D2: Extramedullary involvement: Including documented cutaneous, pleural or pericardial effusion.
- No prior treatment (except supportive care, or ESA, or short term (\< 6 weeks) HY in patients presenting with high WBC counts)
- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Adequate organ function including the following Hepatic : total bilirubin \< 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) \< 3xULN Renal : serum creatinine \< 2 x ULN
- Signed Informed consent
- Negative pregnancy and adequate contraception (including in male patients wishing to father) if relevant.
Exclusion
- Myeloproliferative / myelodysplastic syndrome other than CMML
- CMML with t(5 ;12) or PDGFBR rearrangement that may receive imatinib
- Patients eligible for allogeneic bone marrow transplantation with an identified donor
- Pregnant or breastfeeding
- Performance status \> 2 on the ECOG Scale.
- Serious concomitant systemic disorder, including active bacterial, fungal or viral infection that in the opinion of the investigator would compromise the safety of the patient and/or his/her ability to complete the study
- Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2021
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT02214407
Start Date
October 14 2014
End Date
August 16 2021
Last Update
November 19 2021
Active Locations (45)
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1
CHU La Réunion - Site nord
Saint-Denis, La Réunion, France, 97400
2
CHU La Réunion-Site Sud
Saint-Pierre, La Réunion, France, 97410
3
Chu Amiens
Amiens, France, 80054
4
CHU d'Angers
Angers, France, 49 000