A phase II study of the efficacity and the safety of lenalidomide in subjects with intermediate or the high risk myelodysplastic syndromes (MSD) associated with a deletion (Del) 5q[31]

• Conditions: Myelodysplastic syndrome (MDS) is a clonal disease of the bone marrow stem cells. The disease is frequent/asociated with cytopenia and/or blastosis. an evolution to an acute leukemia is not frequent (30%). Treatments are very disapointing especially for high risk MDS. The pronossis mainly depens on blastosis, cytopenia and cytogenetic abnormalities but the disease is typically uncurable ( expect BMT).

• Registration Number: EUCTR2007-000246-13-BE
• Lead Sponsor: Groupe Français des myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age = 18 years at the time of signing the informed consent form
2. Must understand and voluntarily sign an informed consent form

3. Must be able to adhere to the study visit schedule and other protocol requirements
4. Concurrent corticosteroids used for medical conditions other than MDS allowed provided subject is on a stable or decreasing dose for = 1 week prior to study entry
5. Prior thalidomide allowed
6. 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
7 Women of childbearing potential (WCBP?) must have a negative serum or urine pregnancy test 10 – 14 days and again within 24 hours prior to starting study drug. In addition, sexually active WCBP must agree to continued abstinence from heterosexual intercourse or use 2 adequate contraceptive methods, started at least one month prior to onset of treatment, and continued during the whole study until the first menstruations that follow treatment discontinuation (See appendix for acceptable methods). WCBP must agree to have pregnancy tests weekly for the first 4 weeks, then every 4 weeks if menstruation is regular or every 2 weeks if menstruation is irregular,while on study drug. Negativity of the test should be checked before restarting treatment
8Platelet count > 25,000u/L
9.Absolute Neutrophil count > 500u/L

? (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating females.
2.Prior therapy with lenalidomide
3.Proliferative (WBC = 13,000/mL) chronic myelomonocytic leukemia (CMML)
4.Prior = grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide
5.Prior desquamating (blistering) rash while taking thalidomide
6.Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years
7.Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
8.Less than 6 months since prior allogeneic bone marrow transplantation
9.Less than 3 months since prior autologous bone marrow or stem cell transplantation
10.Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
11.Use of androgens other than for treating hypogonadism
12.Known HIV-1 positivity
13. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
14. Any of the following laboratory abnormalities:
?Serum creatinine > 2.0 mg/dL (177 mmol/L)
?Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
?Serum total bilirubin > 1.5 mg/dL,:
15.Subjects with = grade-2 neuropathy
16.Clinically significant anemia due to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified