18 and older, any sex, with T-Acute Lymphoblastic Leukemia or Adult T Lymphoblastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse EventsPrimary· Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days)
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event reporting.
Grade 3-5 white blood cell increased post BL-8040 injection
Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3)
-Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
4
Overall Response Rate (CR, CRi + PR)Secondary· Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)
* Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3)
* Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL
* Partial remission (PR)=A PR requires all of the CR criteria except that marrow may still co
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
5
Time to ResponseSecondary· Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)
* Response is CR or CRi
* Complete remission (CR) = an absolute neutrophil count (segs and bands) \> 1,000/mcL, no circulating lymphoblasts, platelets ≥ 100,000/mcL; and \< 5% marrow leukemia blast cells with complete disappearance of all measurable disease as confirmed by physical examination, CT scan and/or FDG-PET (Deauville criteria score of 1, 2, or 3)
* Morphologic complete remission with incomplete blood count recovery (CRi)=Defined as CR with the exception of neutropenia \< 1,000/mcL or thrombocytopenia \<100,000/mcL
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
20
20 – 39
Duration of ResponseSecondary· Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment)
Defined as the interval from the date CR/CRi is documented to the date of recurrence or completion of follow-up if recurrence has not occurred.
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
280
54 – 471
Event-free Survival (EFS)Secondary· Through completion of follow-up (maximum of 2 years after completion of treatment)
EFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, of death due to any cause.
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
23
13 – 314
Overall SurvivalSecondary· Through completion of follow-up (maximum of 2 years after completion of treatment)
Defined as the date of first dose of study drug to the date of death from any cause.
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
95
24 – 440
Rate of Patients Who Proceed to alloHCT After TreatmentSecondary· Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)
Estimate rate of patients who proceed to alloHCT after treatment
Group
Value
95% CI
Arm 1: BL-8040 and Nelarabine
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment through 30 days after the last study treatment (maximum of 4 cycles of treatment - each cycle is 21 days). All-cause mortality was collected from first dose of study treatment through completion of follow-up (maximum of 2 years following completion of treatment)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1: BL-8040 and Nelarabine
Serious: 8/12 (67%)
Deaths: 9/12
Serious adverse events (12 terms)
Reaction
System
Arm 1: BL-8040 and Nelarab…
Sepsis
Infections and infestations
—
Leukocytosis
Blood and lymphatic system disorders
—
Chest pain - cardiac
Cardiac disorders
—
Fatigue
General disorders
—
Non-cardiac chest pain
General disorders
—
Lung infection
Infections and infestations
—
Hip fracture
Injury, poisoning and procedural complications
—
Pain at BL-8040 injection site
Injury, poisoning and procedural complications
—
Disease progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Altered mental status
Nervous system disorders
—
Peripheral motor neuropathy
Nervous system disorders
—
Hypotension
Vascular disorders
—
Other adverse events (101 terms — click to expand)
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 complete remission (CR) rate than nelarabine alone without an increase in toxicity and will allow patients to proceed to a potentially curative allogeneic hematopoietic cell transplant.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03154827 — Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myelo
· Phase 1, PHASE2
· terminated
NCT03281369 — A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metasta
· Phase 1, PHASE2
· completed
NCT03193190 — A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenoca
· Phase 1, PHASE2
· completed
NCT02639559 — Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 31 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02763384.