Maintenance treatment with low-dose lenalidomide after allogeneic stem cell transplantation for patients with acute myeloid leukaemia or myelodysplastic syndrome

Phase 1

Recruiting

• Conditions: Acute myeloid leukaemia; Myelodysplastic syndrome; Blood - Haematological diseases; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12619000556145
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-10
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Each patient must have one of the following:
a. High risk AML, defined as any of:
• Not in complete remission (CR) at time of alloHSCT
• Adverse risk cytogenetics at any stage of disease
• FLT3-ITD mutation
• Prior induction failure
• Evidence of pre-transplant minimal residual disease either by cytogenetics or by flow cytometry. If flow cytometry is the selected method used, MRD must be greater than 0.1%.
• In second complete remission if duration of first complete remission was less than or equal to 6months.
• Transformation from myeloid neoplasm at any stage

OR

b. High risk MDS, defined as any of:
• Adverse risk cytogenetics at any stage of disease
• Over 10% blasts in blood or marrow aspirate pre-transplant

AND must meet ALL of the following general inclusion criteria:
a.Age 18 years or older.
b.No prior exposure to lenalidomide.
c. Alkaline phosphatase and transaminases less than or equal to 2 x ULN
d. Creatinine clearance greater than or equal to 30 ml/min (calculated by Cockcroft-Gault formula
e. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation
f. Male patients must use contraception during lenalidomide treatment and for 1 week after completion of treatment
g. ECOG performance status 0-2
h. Life expectancy greater than 6 months
i. Patient’s written informed consent
j. Subjects must agree not to share their medication and return unused supplies

Exclusion Criteria

a. Grade 2-4 aGVHD
b. Relapsed or progressive disease on screening bone marrow biopsy
c. Active second malignancy currently requiring treatment
d. Known hypersensitivity with anaphylactic reaction to lenalidomide
e. Class III or IV cardiac disease defined by the NYHA.
f. Severe or debilitating pulmonary disease.
g. Severe or debilitating central nervous system disease or cerebral dysfunction.
h. Active bacterial, viral or fungal infection
i. Human Immuno-deficiency Virus (HIV) infection.
j.Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
k. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified