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

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]

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00424229

Enrollment

Registered

2007-01-18

Start date

2006-10-31

Completion date

2008-10-31

Last updated

2007-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide

Brief 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\[31\]

Detailed description

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).

Interventions

DRUGLENALIDOMIDE

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement	—

Countries

France

Contacts

Primary Contact.Pierre FENAUX, Professor

pierre.fenaux@avc.aphp.fr0033148955070

Backup ContactFatrima-Zohra HAMZA, CRA

fatima.hamza@aphp.fr0033148955890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026