Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

• Status: Unknown status
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Age > 18 years at the time of signing the informed consent form

• MDS with IPSS scores Int-2 or high with deletion 5q(31)

• Prior thalidomide allowed

• Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities

Exclusion Criteria:

• Pregnant or lactating females

• Prior therapy with lenalidomide

• MDS with IPSS scores low or Int-1

• Clinical neuropathy of greater than grade 2

• Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)

• Recombinant human erythropoietin (rHuEPO) therapy received within 28 days

• Use of androgens other than for treating hypogonadism