IRB #

STUDY00022553

Title

[NCI CIRB] S1905: A PHASE I/II STUDY OF AKR1C3-ACTIVATED PRODRUG OBI‐3424 (OBI-3424) IN PATIENTS WITH RELAPSED/REFRACTORY T‐CELL ACUTE LYMPHOBLASTIC LEUKEMIA (T-ALL) / T-CELL LYMPHOBLASTIC LYMPHOMA (T-LBL)

Principal Investigator

Jessica Leonard

Study Purpose

The purpose of this study is to determine if this approach to treating T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma is better or worse than the usual approach.

Medical Condition(s)

T-Cell Acute Lymphoblastic Leukemia
T-Cell Lymphoblastic Lymphoma

Eligibility Criteria

1- Diagnosis of relapsed or refractory T-ALL. Patient with relapsed T-Cell Lymphoblastic Lymphoma are eligible if lymphoblasts are >5% in the bone marrow or peripheral blood.

2- Patients must have evidence of acute leukemia in their peripheral blood or bone marrow, defined as >5% lymphoblast present. Patients with only intramedullary disease are not eligible.

3- Prior treatment must be complete within 14 days of study registration.

4- Prior nelarabine therapy is not required. However, patients that have received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy.

5- >18 years of age

6- Performace status of 0-3

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

5 years after registration

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

SWOG

Recruitment End

01/31/2023

Compensation Provided

No


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