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T-Acute Lymphoblastic LeukemiaPhase 2NCT02763384

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

A Phase 2 study testing BL-8040 and Nelarabine in people with T-Acute Lymphoblastic Leukemia and Adult T Lymphoblastic Lymphoma, run by Washington University School of Medicine at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BL-8040 and Nelarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
2 Dec 2016to 22 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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 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 contraception for the subject.
  • 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:
  • ≥ 45 years of age and has not had menses for > 2 years
  • Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation
  • 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.
  • Able to understand and willing to sign an IRB-approved written informed consent document.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase IIa Study of BL-8040 in Combination With Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma

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.

Being tested
BL-8040, Nelarabine
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-8040Drug

  • NelarabineDrug

    Also called Arranon

Study groups in NCT02763384
Study groupRoleWhat they receive
Arm 1: BL-8040 and NelarabineExperimental* 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
Receives: Drug: BL-8040; Drug: Nelarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events

    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.

    Measured: Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days)

Secondary outcomes (7)

  1. Composite Complete Remission Rate (CRc=CR+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

    Measured: Completion of treatment (approximately 12 weeks)

  2. Overall Response Rate (CR, CRi + PR)

    • 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 contain 5-25% leukemia blast cells. An absolute neutrophil count (segs and bands) ≥ 1000/mcL, no circulating blasts, and platelets > 100,000/mcL are requires as for a CR. For patients with measurable disease, a reduction of 50% or more in the sum of the products of the perpendicular diameters of all measurable lesions compared with pretreatment measurements and with no new or enlarging lesions

    Measured: Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)

  3. Time to Response

    • 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

    Measured: Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)

  4. Duration of Response

    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.

    Measured: Through date of recurrence or completion of follow-up (maximum of 2 years after completion of treatment)

  5. Event-free Survival (EFS)

    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.

    Measured: Through completion of follow-up (maximum of 2 years after completion of treatment)

  6. Overall Survival

    Defined as the date of first dose of study drug to the date of death from any cause.

    Measured: Through completion of follow-up (maximum of 2 years after completion of treatment)

  7. Rate of Patients Who Proceed to alloHCT After Treatment

    Estimate rate of patients who proceed to alloHCT after treatment

    Measured: Through completion of treatment (median treatment length of 37.5 days, full range of 13-90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study start2 Dec 2016
  3. Primary completion11 Feb 2022
  4. Study completion22 May 2022

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763384
Sponsor's protocol ID
201606146
Other IDs
2P50CA171963-06
Status last verified
Oct 2023
First submitted
3 May 2016
Last updated
31 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-8040 and Nelarabine in people with T-Acute Lymphoblastic Leukemia and Adult T Lymphoblastic Lymphoma, run by Washington University School of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Regimen as Measured by Number of Participants With Adverse Events (time frame: Up to 30 days after completion of treatment (median follow-up of 51.5 days, full range 24-120 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02763384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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