NCT03982992: DLI-TARGET

Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

Withdrawn Phase 2 Last updated 12 March 2024

What this trial tests

Phase 2 trial testing Blinatumomab in combination with donor lymphocyte infusion in B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation. Withdrawn.

Timeline

1 June 2019

Primary endpoint
31 May 2021

30 November 2021

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 June 2019
Primary completion	31 May 2021
Estimated completion	30 November 2021
Sites	1 location across Germany

Drugs / interventions tested

• Blinatumomab in combination with donor lymphocyte infusion — full drug profile →

Conditions studied

• B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation — all drugs for B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation →
• B-Cell Acute Lymphoblastic Leukemia — all drugs for B-Cell Acute Lymphoblastic Leukemia →
• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Acute Lymphoblastic Leukemia in Remission — all drugs for Acute Lymphoblastic Leukemia in Remission →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation or B-Cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase 2 study is designed to evaluate the safety, tolerability and efficacy of allogeneic donor lymphocyte infusions (DLI) combined with the bispecific T cell engager blinatumomab in B-precursor ALL patients who have mixed chimerism (MC) or are MRD-positive after allogeneic SCT and are refractory to at least one MRD- or MC-targeted therapy (i.e. blinatumomab, DLI, tyrosine kinase inhibitors or other agents).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The landscape of bispecific T cell engager in cancer treatment.
   Zhou S, Liu M, Ren F, Meng X, et al · · 2021 · cited 172× · PMID 34039409 · DOI 10.1186/s40364-021-00294-9
2. Concepts in immuno-oncology: tackling B cell malignancies with CD19-directed bispecific T cell engager therapies.
   Viardot A, Locatelli F, Stieglmaier J, Zaman F, et al · · 2020 · cited 31× · PMID 32856140 · DOI 10.1007/s00277-020-04221-0
3. Immunotherapy of Acute Lymphoblastic Leukemia and Lymphoma With T Cell-Redirected Bispecific Antibodies.
   Lussana F, Gritti G, Rambaldi A. · · 2021 · cited 26× · PMID 33434063 · DOI 10.1200/jco.20.01564
4. Recent advances on blinatumomab for acute lymphoblastic leukemia.
   Zhao J, Song Y, Liu D. · · 2019 · cited 25× · PMID 31709129 · DOI 10.1186/s40164-019-0152-y
5. Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in Adults.
   Saleh K, Fernandez A, Pasquier F. · · 2022 · cited 24× · PMID 35406576 · DOI 10.3390/cancers14071805
6. Current Advances in Immunotherapy for Acute Leukemia: An Overview of Antibody, Chimeric Antigen Receptor, Immune Checkpoint, and Natural Killer.
   Shang Y, Zhou F. · · 2019 · cited 16× · PMID 31616632 · DOI 10.3389/fonc.2019.00917
7. Blinatumomab for HLA loss relapse after haploidentical hematopoietic stem cell transplantation.
   Wu H, Cai Z, Shi J, Luo Y, et al · · 2021 · cited 11× · PMID 34249448
8. New developments in ALL in AYA.
   Boissel N. · · 2022 · cited 4× · PMID 36485092 · DOI 10.1182/hematology.2022000336