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OncoMatch/Clinical Trials/NCT04315324

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

Is NCT04315324 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies AKR1C3-activated Prodrug AST-3424 for recurrent t acute lymphoblastic leukemia.

Phase 1/2RecruitingSWOG Cancer Research NetworkNCT04315324Data as of May 2026

Treatment: AKR1C3-activated Prodrug AST-3424This 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.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Performance status

ZUBROD/LANSKY 0–3

Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients < 16 years of age must have a Lansky score of ≥ 50

Prior therapy

Must have received: chemotherapy (vincristine, corticosteroids, cytarabine, anthracycline) — induction or consolidation

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)

Cannot have received: allogeneic hematopoietic transplant

Exception: allowed if > 90 days prior to registration

Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration

Lab requirements

Blood counts

PT/PTT/fibrinogen as clinically indicated; sodium, potassium, chloride, CO2, BUN within 14 days prior to registration to obtain baseline measurements

Kidney function

Patients ≥ 18 years: creatinine clearance > 30 mL/min within 14 days prior to registration (Cockcroft Gault); Patients 12-17 years: serum creatinine ≤ 1.5 x institutional ULN or eGFR (Schwartz) or radioisotope GFR ≥ 50ml/min/1.73 m^2 within 14 days prior to registration

Liver function

direct bilirubin <= 1.5 x institutional ULN within 14 days prior to registration; ALT <= 3.0 x institutional ULN or <= 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration

Cardiac function

No known history of prolonged QT interval by Fridericia (QTcF > 450 msec for males; > 470 msec for females); transient prolongation due to medications/electrolytes allowed if resolved

Patients must have direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration; Patients must have alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (ULN) or =< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration; Patients ≥ 18 years of age must have creatinine clearance > 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation; Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m^2; Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements); From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements); Patients must not have a known history of prolonged QT interval by Fridericia (QTcF > 450 msec for males; > 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval > 450 msec for males; > 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
  • Kingman Regional Medical Center · Kingman, Arizona
  • Arkansas Children's Hospital · Little Rock, Arkansas
  • PCR Oncology · Arroyo Grande, California
  • City of Hope Comprehensive Cancer Center · Duarte, California

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