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Anti-cancer agent

BL-8040 for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Geoffrey L Uy, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days)
Awards & highlights

Study Summary

This trial is testing a new way to treat T-cell leukemia that has relapsed or is resistant to other treatments. The new treatment targets a protein called CXCR4 that is involved in cancer cell maintenance and growth. The goal of the trial is to see if the new treatment, in combination with another drug called nelarabine, results in more patients achieving complete remission than nelarabine alone.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • T-Cell Lymphoblastic Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events
Secondary outcome measures
Composite Complete Remission Rate (CRc=CR+CRi)
Duration of Response
Event-free Survival (EFS)
+4 more
Other outcome measures
Interaction of Pretreatment Disease and CXCR4 Expression on Lymphoblasts on Clinical Outcome
Interaction of Pretreatment Disease and Cytogenetics on Clinical Outcome
Interaction of Pretreatment Disease and Immunophenotype on Clinical Outcome
+7 more

Side effects data

From 2023 Phase 2 trial • 50 Patients • NCT02639559
88%
Lymphocyte count increased
88%
Platelet count decreased
80%
Allergic reaction
80%
Injection site reaction
68%
Anemia
44%
Hypertension
40%
Hypocalcemia
28%
Lymphocyte count decreased
24%
Cholesterol high
24%
Oral dysesthesia
20%
Nausea
16%
Hypertriglyceridemia
12%
Fatigue
12%
Paresthesia
12%
Headache
8%
Sinus tachycardia
8%
Allergic rhinitis
8%
Bone pain
8%
Hyperglycemia
8%
Hepatitis B Core Ab positive
8%
Hypotension
8%
Vomiting
8%
White blood cell decreased
4%
Weight loss
4%
Toothache
4%
Type II diabetes
4%
Activated partial thromboplastin time prolonged
4%
Hemoglobin increased
4%
Numbness in arms
4%
Dysgeusia
4%
Infusion related reaction
4%
Fever
4%
A1c increased
4%
Foot pain
4%
Dyspnea
4%
Alkaline phosphatase increased
4%
Anxiety
4%
Arthralgia
4%
Atrial fibrillation
4%
Bruising
4%
Chills
4%
Dizziness
4%
Dysesthesia
4%
Eye pain
4%
Hyperkalemia
4%
Hypomagnesemia
4%
Mild head cold
4%
Neutrophil count decreased
4%
Pain
4%
Leg/knee pain
4%
Localized edema
4%
Insomnia
4%
Pain in extremity
4%
Papulopustular rash
4%
Rash maculo-papular
4%
Sinus brachycardia
4%
Vibration sensation
4%
Watering eyes
4%
Gastrointestinal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: Donors
Arm 2: Recipients

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1: BL-8040 and NelarabineExperimental Treatment2 Interventions
Cycle 1: BL-8040 subcutaneous daily from Day 1 to Day 6 and nelarabine intravenously over 2 hours on Days 2, 4, and 6 Cycles 2-4: BL-8040 subcutaneous daily from Day 1 to Day 5 and nelarabine intravenously over 2 hours on Days 1, 3, and 5 Treatment may be repeated every 21 days for up to 4 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BL-8040
2014
Completed Phase 2
~220
Nelarabine
2008
Completed Phase 2
~500

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,260 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,861 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma
2016. "BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02763384.
~1 spots leftby Apr 2025
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