ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

A phase II trial of continuous intravenous infusion of Blincyto given over a 28-day cycle. Starting day for patients who are MRD-positive before HSCT is between day +60 and day +100 and for patients who become MRD-positive post HSCT it is between day +60 and day +360 post HSCT.

Patients will be evaluated for response at day +28 (+4 days) (bone marrow morphology and MRD analysis - defined by PCR/FLOW-techniques) after start of Blincyto-treatment at the end of first Blincyto infusion and at regular post-TX-checks (according to FORUM: days +28, +60, +100, +180 and +360 after HSCT).

The dose of Blincyto used in this trial will be 15 mcg/m2/day for 28 days

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Christina Peters
• Collaborator: Amgen
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

• Patients participating in ALL SCTped 2012 FORUM;

• Age: > 0.5 years and < 21 years;

• B-precursor ALL with < 5% blasts in the bone marrow (M1 bone marrow) and CD19+ minimal residual disease (MRD) before and/or following allogeneic HSCT;

• Indication for first allogeneic HSCT was CD19+ ALL in first, second or third remission;

• Allogeneic Hematopoietic Stem Cell Transplant (HSCT): at first dose of Blincyto patients must be at least > 60 days post-SCT and without evidence of grade 2 or higher acute GVHD and off systemic immunosuppression (tapering allowed) and at least 4 weeks after last donor lymphocyte infusion (DLI);

• Performance-Status (Karnovsky/Lansky): above 50%;

• Written consent of the parents/legal guardian and, if necessary, the minor patient via "Informed Consent Form";

• No pregnancy;

• No secondary malignancy.

Exclusion Criteria:

• Patients who do not fulfill the inclusion criteria;

• The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian;

• Malformation syndromes;

• Renal impairment (< 30% of normal glomerular filtration rate);

• Severe pulmonary, hepatic or cardiac impairment due to toxicity or infection (> CTCAE grade 3);

• Recent episode of seizures or posterior reversible encephalopathy syndrome in the past 30 days;