BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma

  • STATUS
    Recruiting
  • End date
    Apr 30, 2025
  • participants needed
    20
  • sponsor
    Washington University School of Medicine
Updated on 7 July 2022

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.

Details
Condition T-Acute Lymphoblastic Leukemia, Adult T Lymphoblastic Lymphoma
Treatment BL-8040, Nelarabine
Clinical Study IdentifierNCT02763384
SponsorWashington University School of Medicine
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of T-acute lymphoblastic leukemia/ lymphoblastic lymphoma according to WHO criteria which has relapsed or is refractory to chemotherapy
Peripheral blood lymphoblasts ≤ 50,000 mcL. Hydroxyurea and/or leukapheresis is permitted to reduce the peripheral blast count prior to enrollment and treatment
Age ≥ 18 years
ECOG performance status ≤ 2
Adequate organ function defined as
Calculated creatinine clearance ≥ 50 ml/min using the Cockroft-Gault formula
AST, ALT, total bilirubin ≤ 2 x institutional ULN except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x IULN
Women of childbearing potential and men must agree to use adequate contraception with
Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to start of study treatment if of childbearing potential or be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as
a highly effective method (hormonal or barrier method of birth control
abstinence) prior to study entry and for the duration of study participation
Abstinence is acceptable if this is the established and preferred
Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation
contraception for the subject
Post-hysterectomy, oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure
≥ 45 years of age and has not had menses for > 2 years
Able to understand and willing to sign an IRB-approved written informed consent
document

Exclusion Criteria

Previous treatment with nelarabine for relapsed or refractory disease
Pregnant or nursing
Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks
Active CNS involvement with leukemia
Active HIV or hepatitis B or C infection
Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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