ALL Backbone in AYAs

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07227584
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

First listed
Nov 12, 2025
Start date
Apr 30, 2026
Status verified
Nov 2025
Primary completion
Jul 31, 2030
Completion
Jul 31, 2035

Study Design

Enrollment
67 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALL Backbone Regimen for B-Cell
    * Steroid Prophase (3-dy cycle): Dexamethasone \& cytarabine * Induction IA (29-dy cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy * Induction IB (42-dy cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy * Blinatumomab Cycle 1, 2 (42-dy cycles): Blinatumomab, dexamethasone, IT chemotherapy * Consolidation I: * Phase IA (28-dy cycle), Phase IC (21-dy cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy * Blinatumomab Cycle 3 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy * Consolidation II (21-dy cycles for 30 wks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy * Blinatumomab Cycle 4 (42-dy cycle): Dexamethasone, Blinatumomab, IT chemotherapy * Continuation (21-dy cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy * End of treatment visit * Follow up
  • Experimental: ALL Backbone Regimen for T-Cell
    * Steroid Prophase (3-day cycle): Dexamethasone and cytarabine * Induction IA (29-day cycle): Vincristine, dexamethasone, pegaspargase, doxorubicin, IT chemotherapy * Induction IB (42-day cycle): Cyclophosphamide, cytarabine, mercaptopurine, IT chemotherapy * Consolidation I: * Phase IA (28-day cycle) and Phase IC (21-day cycle): Vincristine, mercaptopurine, methotrexate, dexamethasone, cytarabine, etoposide, pegaspargase, IT chemotherapy * CNS Phase (21-day cycle): Dexamethasone, vincristine, mercaptopurine, pegaspargase, IT chemotherapy * Consolidation II (21-day cycles for 30 weeks): Vincristine, dexamethasone, mercaptopurine, doxorubicin, methotrexate, pegaspargase, IT chemotherapy * Continuation (21-day cycles): Vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy * End of treatment visit * Follow up

Primary Outcome Measure

Treatment Completion Rate Through Time Point 3 (TP3) [ Time Frame: 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 ]

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