A study to evaluate efficacy and safety of azazitidin alone or in combination with lenalidomide in patients with advanced cancer in the bone marrow or in the blood with a defective chromosome 5

Phase 1

• Conditions: Myelodysplastic syndrome and acute myeloid leukemia with a deletion of 5q; MedDRA version: 15.0 Level: LLT Classification code 10067096 Term: 5q minus myelodysplastic syndrome System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-001639-21-DK
• Lead Sponsor: MDSG Nordics Myeloplastics Syndrom Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study (del(5q) confirmed by FISH in all cases):
•18 years of age or older 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 vasecomized 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.
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

•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

Study & Design

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