ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

NCT04785547 | Terminated Phase 2 FDA Drug

• 1 other identifier: FORUM Add-on Blina post TX
• Study Type: interventional
• Target: 3
• Locations: 10 countries
• Sites: 14

Brief Summary

An add-on phase II trial within the ALL SCTped 2012 FORUM with the primary objective to determine whether the use of Blincyto in paediatric patients with B-lineage ALL and pre- and/or post-transplant MRD could induce MRD-negativity in patients who were MRD-positive before and/or after allogeneic HSCT. The study protocol entitled "A Phase II Study of Blincyto (Blinatumomab) in Children with CD19+ B-lineage Acute Lymphoblastic Leukemia (ALL) and Minimal Residual Disease (MRD)-Positivity before or following first Allogeneic Hematopoetic Stem Cell Transplantation (HSCT) in complete remission (CR1, CR2, CR3)" was included in the ALL SCTped 2012 FORUM Protocol Appendix 1b. According to protocol, 15 mcg/m2/day of Blincyto is given in continuous intravenous infusion 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 are 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 protocol was approved in 10 countries (Austria, Belgium, Czech Republic, Denmark, France, Italy, Norway, Poland, Slovakia and Spain) participating ALL SCTped 2012 FORUM study. Overall, 3 patients were treated with Blincyto (2 in Oslo and 1 in Copenhagen). However, the Investigator Initiated Research Agreement was terminated by Amgen on 26 April 2022, leading to an early termination of the study, which was approved with the last protocol amendment.

Conditions

ALL, Childhood; Minimal Residual Disease

Keywords

MRD Positivity

Outcome Measures

Primary Outcomes (1)

• Rate of MRD-negativity

  Rate of MRD-negativity is defined as \< 0.01 percent (%) by flow cytometry and \< 10-4 by PCR after first and second Blincyto cycle

  Patients may receive 2 cycles of treatment. A single cycle of treatment is 28 days (4 weeks) of continuous infusion. Each cycle of treatment is separated by a 14 day (2 weeks) treatment-free interval.

Study Arms (1)

Blincyto

EXPERIMENTAL

Blincyto is 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.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

15 mcg/m2/day for 28 days

Also known as: Blincyto

Blincyto

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Prof. Christina Peters: lead
• Amgen: collaborator

Study Sites (14)

St. Anna Kinderspital

Vienna, Austria(AUT), 1090, Austria

Location

University Hospital Gasthuisberg (UZ Leuven)

Leuven, Belgium

Location

Motol University Hospital Prague

Prague, Czechia

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Hôpital Robert Debré, Paris

Paris, France

Location

Ospedale S. Gerardo Monza

Monza, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesù Roma

Roma, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

Nicolaus Copernicus University Collegium Medicum

Bydgoszcz, Poland

Location

Lublin, Medical Academy

Lublin, Poland

Location

University of Medical Sciences Poznan

Poznan, Poland

Location

Klinika Transplantacji Szpiku

Wroclaw, Poland

Location

University Children's Hospital

Bratislava, Slovakia

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina Peters, MD

  St.Anna Kinderspital, Vienna, Austria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof. Dr. Christina Peters

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: December 17, 2020
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CZ (1); DK (1); PL (4); FR (1); ES (1); SL (1); NO (1); BE (1); IT (2); AU (1)