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ALL Backbone in AYAs

NCT07227584 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-11-12

No results posted yet for this study

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)

Conditions

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Marlise R Luskin, MD, MSCE · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2030-07-31
Completion
2035-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227584 on ClinicalTrials.gov