Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04315324|
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent T Acute Lymphoblastic Leukemia Refractory T Acute Lymphoblastic Leukemia||Drug: AKR1C3-activated Prodrug OBI-3424||Phase 2|
I. To assess the response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) of AKR1C3-activated prodrug OBI-3424 (OBI-3424) in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL).
I. To estimate the frequency and severity of toxicities of OBI-3424 in this patient population.
II. To estimate event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS) in this patient population.
TRANSLATIONAL MEDICINE OBJECTIVES:
I. To estimate minimal/measurable residual disease (MRD) negativity (among patients who achieve CR or CRi).
II. To bank specimens for future research.
Patients receive AKR1C3-activated prodrug OBI-3424 intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for up to 5 years from registration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)|
|Actual Study Start Date :||August 17, 2020|
|Estimated Primary Completion Date :||April 7, 2024|
|Estimated Study Completion Date :||April 7, 2025|
Experimental: Treatment (AKR1C3-activated prodrug OBI-3424)
Patients receive AKR1C3-activated prodrug OBI-3424 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Drug: AKR1C3-activated Prodrug OBI-3424
- Response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) [ Time Frame: Up to 5 years ]
- Incidence of adverse events [ Time Frame: Up to the time of relapse, assessed up to 5 years ]Toxicities will be captured and described. The probability of any particular toxicity can be estimated to within at most +/- 17% (95% confidence interval).
- Overall survival [ 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 ]Will be estimated using the Kaplan-Meier method.
- Event-free survival [ 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 ]Will be estimated using the Kaplan-Meier method.
- Relapse-free survival [ 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 ]Will be estimated using the Kaplan-Meier method.
- Minimal residual disease (MRD) rate [ Time Frame: Up to 5 years ]The MRD rate for responders will be reported as a point estimate with an exact binomial confidence interval.
- AKR1C3 expression [ Time Frame: Up to 5 years ]A post-hoc analysis of AKR1C3 expression is planned.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315324
|Principal Investigator:||Anjali S Advani||Southwest Oncology Group|