Treatment for Ph-negative ALL for Adults up to 65 Years

Sponsor
PETHEMA Foundation
Study ID
NCT07443592
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) — DRUG
    Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine). Blinatumomab cycles in consolidation therapy for participants with B-cell precursor ALL.
  • Transplantation — PROCEDURE
    allogeneic stem cell transplantation

Study Details

The goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. The main question is to know if the incorporation of blinatumomab for B-cell precursor ALL, substituting some chemotherapy blocks, offers better probability of survival than the previous trial, which did not use immunotherapy. In addition, T-cell precursor ALL participants will receive different treatment approaches depending on the stage of maturation of the tumor.

Key Dates

First listed
Mar 2, 2026
Start date
Mar 6, 2026
Status verified
Feb 2026
Primary completion
Mar 6, 2031
Completion
Jun 1, 2033

Study Design

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

Arms

  • Other: Chemotherapy (+ blinatumomab for B-cell precursor ALL)
    Pediatric-inspired chemotherapy
  • Other: Transplantation
    allogeneic stem cell transplantation

Primary Outcome Measure

Overall survival comparison versus previous trial [ Time Frame: 5 years ]

Central Contacts

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