InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 2 February 2024

BlinFant: This phase II trial is testing the safety of an immunotherapy treatment in infants with newly diagnosed Acute Lymphoblastic Leukaemia (ALL)A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia

Clinical summary

Conditions

This trial is treating patients with Acute Lymphoblastic Leukaemia (ALL).

Cancer

Blood Cancers Haematological

Age

People>2

Phase

II

Trial Acronym

BlinFant

More information

Trial Identifiers

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

Trial sponsor

AMGEN, Princess Máxima Center for Pediatric Oncology, Go4Children

Scientific Title

A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia

Eligibility

Inclusion

1. Patients must be treated according to Interfant-06 backbone
2. Patients must have newly diagnosed, CD19 positive, B-precursor ALL
3. Morphological verification of the diagnosis, confirmed with immunophenotyping
4. < 365 days of age at time of diagnosis of ALL
5. > 28 days of age at start of blinatumomab administration
6. MR and HR patients according to risk stratification of the Interfant-06 protocol, thus including all MLL-rearranged and MLL not-evaluable patients (these latter are stratified and treated according to MR).
7. M1 or M2 bone marrow after induction (~day 33).
If the peripheral blood shows pancytopenia at day 33 it is justified to postpone the bone marrow puncture according to the Interfant-06 protocol. If the bone marrow at day 33 is hypocellular and one is therefore unable to determine M1 or M2 status, then the bone marrow puncture should be repeated.
8. Written informed consent from parents or guardians

Exclusion

1. Biphenotypic ALL
2. Mature B-ALL
3. Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript
4. M3 marrow after induction
5. Patients with Down syndrome (because of increased toxicity of conventional chemotherapy)
6. Clinically relevant CNS pathology requiring treatment (eg unstable epilepsy)
7. Evidence of CNS involvement of ALL (CNS2 or CNS3) at the end of induction. Subjects with CNS disease at the time of diagnosis are eligible if a CNS1 status is obtained prior to enrolment (lumbar puncture at ~day 29 of induction, see definitions CNS status in Appendix D)
8. Known infection with human immunodeficiency virus (HIV)
9. Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing

Exclusion criteria before start (-d3) of blinatumomab:
1. Peripheral neutrophils <0.5 x 109/l (for M1 marrow only, with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
2. Peripheral platelets < 50 x 109/L (for M1 marrow only with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
3. Creatinine > 1.5 X ULN, based on the normal ranges for age and gender of the local laboratories
4. Direct bilirubin > 3 x ULN unless the patient has documented Gilbert Syndrome
5. Chemotherapy related toxicities that have not resolved to < grade 2
6. Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.