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RecruitingLast updated: 2 February 2024

ALL09: This phase II trial is trying to determine if a new immunotherapy (Blinatumomab) can help treat patients with Acute Lymphoblastic LeukaemiaPhase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia

Clinical summary

Summary

Eligible patients will receive continuous intravenous Blinatumomab over two 28-day cycles, using an infusion device that will be programmed and monitored by the nursing staff.

Conditions

This trial is treating patients with acute lymphoblastic leukaemia

Cancer

Blood Cancers Haematological

Age

People15 - 40

Phase

II

Trial Acronym

ALL09

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

CanTeen Australia

Scientific Title

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

Eligibility

Inclusion

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

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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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