NCT01088373: GFM-AZA-REV-09

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

Completed Phase 2 Last updated 15 December 2017

What this trial tests

Phase 2 trial testing Azacitidine combined to Lenalidomide in Myelodysplastic Syndromes in 50 participants. Completed in 25 July 2016.

Timeline

25 March 2010

Primary endpoint
25 July 2016

25 July 2016

Quick facts

Lead sponsor	Groupe Francophone des Myelodysplasies
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	25 March 2010
Primary completion	25 July 2016
Estimated completion	25 July 2016
Sites	34 locations across France

Drugs / interventions tested

• Azacitidine combined to Lenalidomide — full drug profile →

Conditions studied

• Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Groupe Francophone des Myelodysplasies — full company profile →

Who can join

Adults 18 to 75, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
   Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
2. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x