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Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)

ConditionsRecurrent T Acute Lymphoblastic LeukemiaRefractory T Acute Lymphoblastic LeukemiaRefractory T Lymphoblastic LymphomaT Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorSWOG Cancer Research Network

About this trial

This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are >= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry

Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have >= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible

Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients < 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation)

Vincristine and corticosteroids plus at least one more chemotherapy agent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • AKR1C3-activated Prodrug AST-3424

    Drug

    Given IV

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and CSF sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspirate

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: Treatment (AKR1C3-activated prodrug OBI-3424)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) (Phase I)

The regimen will be considered safe and the MTD determined if the dose-limiting toxicity rate is \< 33%.

Time frame
Up to 21 days
2

Response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) (Phase II)

Time frame
Up to 5 years

Secondary outcomes

1

Incidence of adverse events

Toxicities will be captured and described. The probability of any particular toxicity can be estimated to within at most +/- 17% (95% confidence interval).

Time frame
Up to the time of relapse, assessed up to 5 years
2

Overall survival

Will be estimated using the Kaplan-Meier method.

Time frame
From the day of registration on study until death from any cause with observations censored on the day of last contact for patients not known to have died, assessed up to 5 years
3

Event-free survival

Will be estimated using the Kaplan-Meier method.

Time frame
From the date of initial registration on study until the first of the following events: death from any cause, relapse from remission (CR or CRi) or completion of protocol therapy without documentation of CR or CRi, assessed up to 5 years
4

Relapse-free survival

Will be estimated using the Kaplan-Meier method.

Time frame
From the date the patient first achieves CR or CRi until relapse from CR/CRi or death from any cause, assessed up to 5 years

Other outcomes

1

Minimal residual disease (MRD) rate

The MRD rate for responders will be reported as a point estimate with an exact binomial confidence interval.

Time frame
Up to 5 years
2

AKR1C3 expression

A post-hoc analysis of AKR1C3 expression is planned.

Time frame
Up to 5 years
3

Association between AKR1C3 and MRD-negative remission (CR or CRi) status

Will analyze all patients treated at the MTD.

Time frame
Up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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