NCT07227584

ALL Backbone in AYAs

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

This Phase 2, single-arm research study is to evaluate a chemotherapy regiment the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs). The U.S. Food and Drug Administration (FDA) has approved all of the drugs of treatment being studied but the investigators of this research study want to understand more about the safety and effectiveness of the chemotherapy regimen in adolescents and young adults with newly diagnosed Philadelphia chromosome-negative ALL. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, saliva tests, X-rays, electrocardiograms (ECGs), echocardiograms (ECHOs), Dual-Energy X-ray Absorptiometry (DEXA) scans, bone marrow aspirations/biopsies. Participation in this study is expected to last about 10 years, 2 years of treatment followed by 8 years of follow up. It is expected that about 67 people will take part in this research study.

Conditions

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

Interventions

Type	Name	Description
DRUG	Blinatumomab	A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
DRUG	Oncaspar	A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
DRUG	Cyclophosphamide	An alkylating agent, single-use vial via intravenous infusion, per standard of care
DRUG	Cytarabine	An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
DRUG	Dexamethasone	A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
DRUG	Doxorubicin Hydrochloride	An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
DRUG	Etoposide	A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
DRUG	Mercaptopurine	A purine antagonist, tablet via orally, per standard of care
DRUG	Methotrexate	A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
DRUG	Vincristine	A vinca alkaloid, single-use vials via intravenous injection, per standard of care

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-07-31
• Completion: 2035-07-31
• First posted: 2025-11-12
• Last updated: 2025-11-12

Regulatory

• FDA-regulated drug study