The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed phase II trial is a multicenter, randomized, open-label study that will evaluate the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype including del(5q). The primary objective will be to evaluate the efficacy in terms of response according to International Working Group (IWG) criteria for MDS and AML after 6 cycles of azacitidine or azacitidine + lenalidomide treatment, or at end of study if this occurs at an earlier time point.

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

Details

• Lead Sponsor: Nordic MDS Group
• Treatments: Azacitidine; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• 18 years of age at the time of signing the informed consent form.

• MDS with IPSS Int-2 or High with a karyotype including del(5q).

• Acute myeloid leukaemia (AML) with multilineage dysplasia and 20-30 % blasts (former RAEB-t) with a karyotype including del(5q).

• Subject has signed the informed consent form.

• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide.

• Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide.

Note: Refractory and relapsed patients can be included as long as they fulfil the inclusion criteria.

Exclusion Criteria:

• Eligible for upfront allogeneic SCT without prior induction chemotherapy or azacitidine

• Pregnant or lactating females.

• Prior therapy with azacitidine

• Prior therapy with lenalidomide

• Expected survival less than two months.

• Acute promyelocytic leukemia (APL)

• 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 transferase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)

3. Serum total bilirubin >1.5 mg/dL

• Prior allergic reaction to thalidomide

• Uncontrolled systemic infection