ISRCTN34016918
Active, not recruiting
Phase 2
OPTIMISE-FLT3 - optimising therapy in FLT3-mutated acute myeloid leukaemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute myeloid leukemia
- Sponsor
- Cardiff University
- Enrollment
- 390
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of AML
- •2\. Age \=16 years (no specified upper age limit)
- •3\. Considered fit for intensive AML therapy by the treating physician
- •4\. Confirmed FLT3 ITD or TKD mutation (or FLT3 status unknown but requires urgent therapy \- see below\*)
- •5\. Serum creatinine less than or equal to 1\.5 x ULN (upper limit of normal)
- •6\. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2\.5 x ULN and bilirubin less than or equal to 2 x ULN
- •7\. A negative pregnancy test within 2 weeks prior to trial entry in WOCBP (to be repeated throughout the trial prior to each course of protocol treatment)
- •8\. Sexually mature males and females must agree to use an adequate and medically accepted method of contraception throughout the study and for 6 months following treatment if they or their sexual partners are women of childbearing potential (WOCBP)
- •9\. WHO performance status 0\-2
- •10\. Written informed consent
Exclusion Criteria
- •1\. Receipt of any previous therapy for AML or any antecedent haematological condition (the use of oral hydroxycarbamide to control white blood cell count is permitted)
- •2\. Other active malignancy requiring treatment
- •3\. Patients who are pregnant or lactating
- •4\. Uncontrolled infection with Human Immunodeficiency Virus (HIV) or Hepatitis B or C. Patients with known chronic infections who are receiving or have completed therapy and have recent documented negative viral PCR tests are not excluded
- •5\. Blast transformation of chronic myeloid leukaemia (CML)
Outcomes
Primary Outcomes
Not specified
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