BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
Status:
Recruiting
Trial end date:
2024-10-30
Target enrollment:
Participant gender:
Summary
The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia
(T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30%
of the patients responding to first salvage therapy and long-term survival of only 10%.
Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an unmet
clinical need.
Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell
leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in
T-ALL cells reduces tumor growth in an animal model. In this study, the investigators propose
that the addition of BL-8040 to nelarabine as a salvage therapy for patients with
relapsed/refractory T-ALL/LBL will result in a higher CR rate than nelarabine alone without
an increase in toxicity and will allow patients to proceed to a potentially curative
allogeneic hematopoietic cell transplant.
Phase:
Phase 2
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
National Cancer Institute (NCI) National Institutes of Health (NIH) The Leukemia and Lymphoma Society