ALL09 - Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia

Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 55 人开始时间: 2018年10月22日最近更新: 2024年4月22日

试验速览

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•1.A morphological diagnosis of B-lineage ALL by WHO criteria. All clinico-pathological sub-types will be eligible, except for mature B or Burkitt ALL;
•2.Bone marrow blast count greater than or equal to 20%;
•3.Adequate renal and hepatic function at Screening as defined by:
•a.Total bilirubin less than 2.5 x ULN unless medically correctable
•b.Serum creatinine less than or equal to 200 micromol/L unless medically correctable
•4.Normal left ventricular ejection fraction, according to institutional criteria;
•5.An ECOG performance status score of 0-3 at Screening.

•1. A diagnosis of T-lineage ALL by WHO criteria.
•2. Patients known to have Philadelphia chromosome positive disease as defined by WHO criteria using standard karyotype and/or fluorescence in situ hybridization (FISH) analysis and/or BCR-ABL1 fusion transcript detection
•3. Subjects aged less than 15 or more than 40 years at Screening;
•4. Presence of serious cardiac, pulmonary, hepatic or renal disease;
•5. Previous treatment for ALL or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period).
•6. Positive for HIV, or evidence of uncontrolled Hepatitis B or C infection
•7. Severe active infection
•8. Women who are pregnant at the time of diagnosis will not be excluded from the trial per se. A management plan will be devised between patient, obstetrician and haematologist.

发起方

Australasian Leukaemia and Lymphoma Group