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

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.

Who Can Participate?

Eligibility

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
  • Have 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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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

Harry
Erba

Protocol Number

PRO00112400

NCT ID

NCT04315324

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov