Topic: National Cancer Research Network
Conditions
Interventions
Adverse event discussion, Adverse event discussion 10 minutes. 10 minutes with the doctor (with research nurse if available) within the haematology department
Azacitidine administration, Azacitidine (IMP 1) administration - Azacitidine will be administered by a research nurse/chemotherapy nurse in the haematology department - 20 mins
Bone ma
Discussion of GVHD, Discussion of graft versus host disease symptoms 10 minutes with the doctor (with research nurse if available) within the haematology dept
Electrocardiogram (ECG),
Lenalidomide Education, Lenalidomide Education and Guidance Counselling - 15 mins with the doctor (with research nurse if available) within the haematology department
Medical history, Medical history and demographic data discussion. 30 minutes with the doctor (with research nurse if available) within the haematology department
Patient Diary, Completion of patient diary - Patients will be asked to keep a medication diary from day 10-day 42 of each cycle of therapy (to be completed at the patients convenience).
Physical examination, Physical examination and
vital signs. A d
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD); Timepoint(s): Maximum tolerated dose (MTD) of lenalidomide in combination with azacitidine in patients with relaps | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Best response rate after combined lenalidomide and azacitidine salvage therapy; Timepoint(s): After combined lenalidomide and azacitidine salvage therapy 2. Overall survival; Timepoint(s): Registration - 1yr post trial treatment 3. Tolerability and safety of lenalidomide in combination with azacitidine; Timepoint(s): Each cycle | — |
Countries
United Kingdom
Outcome results
None listed