A trial of combined azacitidine and lenalidomide salvage therapy in patients with acute myeloid leukaemia and myelodysplasia who relapse after allogeneic stem cell transplantatio

Phase 1

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid); Cancer; Acute monoblastic/monocytic leukaemia

• Registration Number: ISRCTN98163167
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2016 Funder report results see attached file ISRCTN98163167 Clinical Trial Summary Report.pdf [1.0a] (added 09/08/2021) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30653424/ (added 09/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Study Completion: 2018-12-31
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Current inclusion criteria as of 10/05/2018:
1. Patients with relapsed AML or MDS following an alemtuzumab- or anti-thymocyte globulin (ATG)-based reduced intensity conditioned allogeneic stem cell transplant using a sibling or unrelated donor
2. Patients able to receive treatment as an outpatient
3. Patients must be willing to comply with the lenalidomide risk management programme
4. Patients must have given written informed consent
5. Patients willing and able to comply with scheduled study visits and laboratory tests

Previous inclusion criteria:
1. Patients with relapsed AML following an alemtuzumab or anti-thymocyte globulin (ATG)-based reduced intensity conditioned allogeneic stem cell transplant using a sibling or unrelated donor
2. Patients able to receive treatment as an outpatient
3. Patients must be willing to comply with the lenalidomide risk management programme
4. Patients must have given written informed consent
5. Patients willing and able to comply with scheduled study visits and laboratory tests

Exclusion Criteria

1. Patients with active acute or chronic extensive graft-versus-host-disease
(GvHD), or a history of grade 3 or 4 GvHD
2. Patients with hepatic or renal impairment defined as follows:
Total bilirubin = 2.5 x upper limit of normal (ULN)*
Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) = 3.0 x ULN
Estimated Glomerular Filtration Rate (eGFR) = 40mls/min
*Patients with elevated bilirubin due to Gilbert's syndrome are eligible
3. Patients who have received anti-tumour
therapies, including prior experimental agents or approved anti-tumour
small molecules and biologics, within 28 days before the start of protocol treatment
4. Patients with active symptomatic fungal, bacterial, and/or viral infection
5. Patients with contraindications to receiving azacitidine or lenalidomide
6. Patients with any other condition that in the Investigators opinion would affect the patient's participation in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD); Timepoint(s): Maximum tolerated dose (MTD) of lenalidomide in combination with azacitidine in patients with relaps

Secondary Outcome Measures

Name	Time	Method
<br> 1. Best response rate after combined lenalidomide and azacitidine salvage therapy; Timepoint(s): After combined lenalidomide and azacitidine salvage therapy<br> 2. Overall survival; Timepoint(s): Registration - 1yr post trial treatment<br> 3. Tolerability and safety of lenalidomide in combination with azacitidine; Timepoint(s): Each cycle<br>