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

ConditionAcute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPETHEMA Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

De novo ALL.

Age 18-65 years.

Adequate general condition (ECOG score 0-2), or >2 if due to ALL.

Negative pregnancy test for women of childbearing age.

Disqualifiers

Age > 65 years.

ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).

Ph-positive B-cell ALL (BCR::ABL1).

Lymphoid blast crisis of chronic myeloid leukemia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    allogeneic stem cell transplantation

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: Chemotherapy (+ blinatumomab for B-cell precursor ALL)Other 1 intervention
Group B: TransplantationOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival comparison versus previous trial

Comparison of time from diagnosis to death or last follow-up between the present LAL-2025 trial and the previous LAL19 trial for adult Ph-negative

Time frame
5 years

Secondary outcomes

1

Complete remission (CR) rate

Proportion of participants who achieve CR with or 2 induction therapy lines

Time frame
4 or 8 weeks after treatment onset
2

MRD status after induction and consolidation

Proportion of participants who achieve and maintain the negative MRD status (\<10-4)

Time frame
After induction (4-8 weeks) and consolidation (16-20 weeks)
3

MRD variation between induction and after cycle 1 blinatumomab

Proportion of B-cell precursor ALL participants who achieve and maintain the negative MRD status (\<10-4) at week 4 or 8 (end of induction 1 or 2) and after week 8 or 12 (after blinatumomab cycle1)

Time frame
After induction (4-8 weeks) and after cycle 1 blinatumomab (8-12 weeks)
4

Frequency of allogeneic stem cell transplantation (alloSCT) dut to high-risk genetics

Proportion of participants that are allocated to alloSCT exclusively due to the presence to high-risk genetic alterations defined in the trial

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PETHEMA Foundation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: