Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]
18 Years
N/A
Both
Myelodysplastic Syndromes
Trial Information
Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]
Subjects meeting all inclusion and exclusion criteria will receive lenalidomide
lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1–21,
every 4 weeks.
Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and
when clinically indicated/for assessment of disease progression) evaluations
Subjects may participate in the study for up to 52 weeks ( in patients still responding
after 52 weeks, the drug wil continue to be supplied).
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement
Principal Investigator
Pierre FENAUX, Profesor
Investigator Role:
Study Director
Investigator Affiliation:
Groupe Francophone des Myelodysplasies
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GFM-REV-2006-02
NCT ID:
NCT00424229
Start Date:
October 2006
Completion Date:
October 2008
Related Keywords:
- Myelodysplastic Syndromes
- MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide
- Myelodysplastic Syndromes
- Preleukemia
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