Pilot safety/tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia/high-risk myelodysplastic syndrome with structural abnormalities of chromosome 5 - AML Len5

Phase 1

• Conditions: Acute myeloid leukaemia / high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5; MedDRA version: 9.1 Level: LLT Classification code 10001941 Term: AML; MedDRA version: 9.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome

• Registration Number: EUCTR2008-004891-28-GB
• Lead Sponsor: eeds Teaching Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-21
• Study Completion: 2013-07-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1) Patients diagnosed with primary/relapsed/refractory AML (as defined by WHO) or high risk MDS (defined as IPSS INT-2/High) with chromosome 5 cytogenetic abnormalities.
2) Aged at least 18 years old
3) Considered suitable for intensive chemotherapy
4) The subject is capable of understanding and complying with protocol requirements.
5) The subject signs a written, informed consent form prior to the initiation of any study procedures
6) Females of child bearing potential must have a negative pregnancy test within 14 days prior to start of lenalidomide and agree to participate and follow the Celgene approved process for Lenalidomide risk management and pregnancy prevention.
7) Males must participate and follow the Celgene approved process for Lenalidomide risk management and pregnancy prevention.

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) Use of prior investigational agents within 4 weeks prior to consent
2) The subject has received lenalidomide in a previous clinical study or as a therapeutic agent.
3) The subject has a history or clinical manifestations of HIV, Hepatitis B or Hepatitis C.
4) The subject has a history of hypersensitivity or allergies to lactose.
5) If female, the subject is pregnant or lactating.
6) The subject has another active malignancy
7) The subject has other severe concurrent disease or mental illness
8) Eastern Cooperateive Oncology Group (ECOG) performance status greater than 2 (Appendix 2).
9) Myocardial dysfunction (as defined by left ventricular ejection fraction <50%)
10) Creatinine clearance (Cockroft) <60 mls/min
11) ALT/AST >3 xULN

Study & Design

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