ALL09 - SUbstitute BLinatumomab to Improve Minimal Residual Disease Eradication in Adolescents and Young Adults with Acute Lymphoblastic Leukaemia – The SUBLIME Study

Phase 2

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukaemia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12618001734257
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the rate of minimal residual disease (MRD) negativity, where MRD negativity is defined as no presence of leukaemic blasts in blood or bone marrow sample as determined by EuroMRD accredited q-pcr analysis [ day 79 of therapy]