A multicentre phase II study of the efficacy and safety of lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotype including del(5q) or monosomy 5. - Lenalidomide in high-risk myeloid disease with 5q

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

• Must be > or =18 years of age at the time of signing the informed consent form
• MDS at IPSS Int-2 or High with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
• Acute myeloid leukemia with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
• Patients could be included if
1. At diagnosis and not considered eligible for induction chemotherapy
2. Refractory to induction therapy
3. Relapse after induction chemotherapy leading to CR and considered not eligible for reinduction
4. Relapse after allogeneic stem cell transplantation and not considered suitable for reinduction chemotherapy or other conventional relapse therapy.
• Subject has signed the informed consent document.
• Women of childbearing potential, WCBP, (A woman of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months ?i.e., has had menses at any time in the preceding 24 consecutive months?) must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of the study medication, while on study medication and 4 weeks after the last dose of study medication. The two methods of contraception must include one highly effective method (i.e. intrauterine device, hormonal ?birth control pills, injections, patches or implants?, tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). However, the doctor may recommend that the subject use two barrier methods for medical reasons. The subject must talk to the doctor before changing any birth control methods she has already agreed to use.
WCBP must have two negative serum or urine pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours of starting study medication. The subject may not receive study drug until the investigator has verified that the results of these pregnancy test are negative. WCBP must agree to have pregnancy tests weekly for the first 4 weeks and then every 4 weeks while on study medication (in woman with regular cycles and every 2 weeks in women with irregular cycles, or earlier in the event the patient discontinues early) and 4 weeks after the last dose of study medication (In women with irregular cycles 2 and 4 weeks after the last dose of study medication).
WCBP will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure before starting study drug and every 4 weeks during study treatment.
• Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication. Male subjects will also be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure before starting study drug and every 4 weeks during study treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)

Exclusion Criteria

• Pregnant or lactating females.
• Prior therapy with lenalidomide
• Patients who are eligible for curative treatment
• Expected survival less than two months.
• Acute promyelocytic leukemia (APL)
• Absolute peripheral blast count >30,000/mm3 (see section 7.1 about the use of hydroxyurea)
• Central nervous system leukemia
• Serum biochemical values as follows
1. Serum creatinine >2.0 mg/dL (177 mmol/L)
2. Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)
3. Serum total bilirubin >1.5 mg/dL (26 micromol/L)
• Prior allergic reaction to thalidomide
• Uncontrolled systemic infection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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