Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)

NCT07227584 Phase 2 NOT_YET_RECRUITING

The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs). The names of the study drugs involved in this study are: * blinatumomab (a type of immunotherapy drug) * cyclophosphamide (a type of chemotherapy drug) * cytarabine (a type of antineoplastic agent) * dexamethasone (a type of synthetic glucocorticoid) * doxorubicin (a type of antineoplastic agent) * etoposide (a type of antineoplastic agent) * mercaptopurine (a type of antineoplastic agent) * methotrexate (a type of chemotherapy drug) * pegaspargase (a type of antineoplastic agent) * vincristine (a type of antineoplastic agent)

Details

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	67
Start date	2026-04
Completion	2035-07-31

Conditions

• Acute Lymphoblastic Leukemia
• Philadelphia Chromosome-Negative Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia (ALL)
• Leukemia

Interventions

• Blinatumomab
• Oncaspar
• Cyclophosphamide
• Cytarabine
• Dexamethasone
• Doxorubicin Hydrochloride
• Etoposide
• Mercaptopurine
• Methotrexate
• Vincristine

Primary outcomes

• Treatment Completion Rate Through Time Point 3 (TP3) — Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum
  Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation.