NCT01088373

Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007). Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q. In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q). Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose). For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response. In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Azacitidine combined to Lenalidomide	Azacitidine: 75mg/m2/d for 5 days per cycle of 28 days. Lenalidomide: 5mg/day during 14 days for cohort 1. Lenalidomide: 5mg/day during 21 days for cohort 2. Lenalidomide: 10mg/day during 21 days for cohort 3.

Timeline

• Start date: 2010-03-25
• Primary completion: 2016-07-25
• Completion: 2016-07-25
• First posted: 2010-03-17
• Last updated: 2017-12-15

Locations

34 sites across 1 country: France