NCT03072771

Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Completed Phase 1 Last updated 28 November 2023

What this trial tests

Phase 1 trial testing Blinatumomab in Diffuse Large B Cell Lymphoma in 14 participants. Completed in 30 October 2023.

Timeline

1 August 2017

Primary endpoint
7 April 2021

30 October 2023

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	1 August 2017
Primary completion	7 April 2021
Estimated completion	30 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Blinatumomab (blinatumomab) — full drug profile →
• Autologous stem cell transplant
• Carmustine (CARMUSTINE) — full drug profile →
• Etoposide (etoposide) — full drug profile →
• Cytarabine — full drug profile →
• Melphalan
• Peripheral blood draws

Conditions studied

• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Diffuse Large B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Based on the further need to improve progression-free survival (PFS) and overall survival (OS) post autologous stem cell transplant (SCT) for DLBCL, the hematopoietic profile of patients following auto-SCT, the activity of blinatumomab in DLBCL and its favorable toxicity profile, the investigators propose a pilot study to test blinatumomab as consolidation therapy post auto-SCT for patients with DLBCL.

The investigators hypothesize the blinatumomab consolidation will optimize the effector to target (E-T) ratio and aid in the eradication of remaining tumor cells, leading to decreased relapse and increased overall survival. In addition, since tumor burden will be at a minimum, infusional toxicities including neurologic toxicities may also be limited. The purpose of this pilot study is to study the feasibility and tolerability of blinatumomab consolidation post auto-SCT for patients with chemo-sensitive DLBCL undergoing auto-SCT.

Publications & conference data

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

1. Long-term outcome of patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with blinatumomab.
   Dufner V, Sayehli CM, Chatterjee M, Hummel HD, et al · · 2019 · cited 66× · PMID 31451445 · DOI 10.1182/bloodadvances.2019000025
2. Blinatumomab, a bispecific B-cell and T-cell engaging antibody, in the treatment of B-cell malignancies.
   Burt R, Warcel D, Fielding AK. · · 2019 · cited 51× · PMID 30380973 · DOI 10.1080/21645515.2018.1540828
3. Emerging therapies in mantle cell lymphoma.
   Hanel W, Epperla N. · · 2020 · cited 33× · PMID 32552760 · DOI 10.1186/s13045-020-00914-1
4. 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
5. The progress of novel strategies on immune-based therapy in relapsed or refractory diffuse large B-cell lymphoma.
   Lu T, Zhang J, Xu-Monette ZY, Young KH. · · 2023 · cited 19× · PMID 37580826 · DOI 10.1186/s40164-023-00432-z
6. T-Cell Engagers-The Structure and Functional Principle and Application in Hematological Malignancies.
   Cech P, Skórka K, Dziki L, Giannopoulos K. · · 2024 · cited 17× · PMID 38672662 · DOI 10.3390/cancers16081580
7. Current Immunotherapy Approaches in Non-Hodgkin Lymphomas.
   Pytlik R, Polgarova K, Karolova J, Klener P. · · 2020 · cited 14× · PMID 33260966 · DOI 10.3390/vaccines8040708
8. The Role of Bispecific Antibodies in Non-Hodgkin's Lymphoma: From Structure to Prospective Clinical Use.
   Tavarozzi R, Manzato E. · · 2022 · cited 9× · PMID 35225874 · DOI 10.3390/antib11010016