A study investigating the use of blinatumomab to treat acute myeloid leukaemia with low level residual disease
- Conditions
- Acute myeloid leukaemia (AML)CancerAcute myeloid leukaemia
- Registration Number
- ISRCTN52962455
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 17
1. Patients with AML with a t(8:21) translocation in complete haematological remission (defined as less than 5% blasts in bone marrow) with a confirmed first or subsequent molecular relapse or molecular persistence of disease (defined according to European Leukaemia Net criteria) following remission induction therapy comprising 2 courses of an anthracycline based regimen or one course of an anthracycline based regimen plus a second course of high dose cytarabine (HDAC).
2. Bone marrow or peripheral blood specimen from primary AML sample taken at diagnosis documented as showing expression of CD19.
3. Bone marrow function as defined below:
3.1. Neutrophils >1x10^9/L - Platelets >20 x 10^12/L (transfusion permitted)
3.2. Haemoglobin level >9g/dl (transfusion permitted)
4. Renal and hepatic function as defined below:
4.1. AST, ALT, and ALP <2 x upper limit of normal (ULN) - Total bilirubin <1.5 x ULN
4.2. Creatinine clearance >50 mL/min (calculated according Cockroft & Gault)
5. Negative HIV test,negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test with the exception of well controlled chronic infections with at least two documented negative PCR tests for viral load.
6. Negative pregnancy test in women of childbearing potential, (as defined in CTFG guidelines)
7. ECOG Performance Status 0 – 2
8. Age 18 years or older
9. Ability to understand and willingness to provide written informed consent.
10. Signed and dated written informed consent is available
1. 5% or more blasts in the bone marrow or the presence of circulating blasts or current extramedullary involvement by AML.
2. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure,paresis,aphasia,cerebrovascular ischemia/haemorrhage,severe brain injuries,dementia,Parkinson’s disease,cerebellar disease,organic brain syndrome,psychosis,coordination or movement disorder).
3. Current infiltration of cerebrospinal fluid by AML.
4. History of or active relevant autoimmune disease.
5. Prior allogeneic HSCT within the last 3 months prior to study treatment.
6. Systemic cancer chemotherapy within 2 weeks prior to study treatment.
7. Radiotherapy within 4 weeks prior to study treatment.
8. Treatment with any investigational product within four weeks prior to study treatment.
9. Previous treatment with blinatumomab.
10. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
11. History of malignancy other than AML within five years prior to treatment start with blinatumomab,with the exception of basal cell or squamous cell carcinoma of the skin,or carcinoma in situ of the cervix.
12. Active infection,any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
13. Nursing women or those with a positive pregnancy test
14. Women of childbearing potential (as defined in CTFG guidelines,see appendix) not willing to use a highly effective form of contraception (as defined in CTFG guidelines) during participation in the study and for at least 3 months thereafter,or male patients not willing to ensure use of highly effective contraception during participation in the study and for at least three months thereafter.
15. Patients with insufficient understanding of the trial to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection RUNX1-RUNX1T1 fusion transcripts on a bone marrow biopsy after one cycle of treatment with blinatumomab
- Secondary Outcome Measures
Name Time Method Measured using patient records:<br>1. Incidence of patients experiencing a grade 3 or greater non-haematological toxicity during the first cycle of treatment. <br>2. Incidence of molecular complete remission on bone marrow biopsy at any time from trial entry (evaluated at end of trial)<br>3. Molecular relapse-free survival time (evaluated at end of trial)<br>4. Overall survival time (evaluated at end of trial)<br>5. Number of days of hospital admission at 1, 3 and 6 months from entry<br>6. Number of days on intravenous antibiotics or antifungals at 1, 3 and 6 months<br>7. Number of blood components infused at 1, 3 and 6 months