S1905 T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called OBI-3424 is a safe and effective option for patients with leukemia or lymphoma.

What is the Condition Being Studied?

Leukemia and Lymphoma

Who Can Participate in the Study?

Adults ages 18+ who have one of the following diagnoses:

  • Relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL); OR
  • Relapsed or refractory T-cell lymphoblastic lymphoma with lymphoblast greater than 5% in the bone marrow or in the peripheral blood; OR
  • Acute leukemia in the peripheral blood or bone marrow with lymphoblasts greater than 5% in the peripheral blood or bone marrow

In addition to the above, all study candidates must also:

  • Have no evidence of central nervous system disease within 28 days of joining based on CSF studies
  • Not used chemotherapy or investigational agents within 14 days prior to joining except for steroids, oral 6-mercaptopurine, oral methotrexate,

vincristine, intrathecal chemotherapy, or hydroxyurea.

  • Have not undergone allogeneic hematopoietic transplant within 90 days prior to joining

For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get the study drug, OBI-3424. Different doses of OBI-3424 will be given to several study participants. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to the next several study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. When the maximum dose is reached, the study will be expanded to additional patients to learn more about that dose.

Study Details

Full Title
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
Professor of Medicine
Protocol Number
IRB: PRO00112400
NCT: NCT04315324
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL