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Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults

ConditionAcute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPETHEMA Foundation

About this trial

After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18-60 yr with de novo Ph-neg ALL

Eastern Cooperative Oncology Group (ECOG) 0-2 (or >2 if due to ALL)

Informed consent

Disqualifiers

Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage

ECOG >2 not due to ALL

Impaired cardiac, respiratory, hepatic or renal function not due to ALL

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pediatric-type of chemotherapy

    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)

  • allogeneic HSCT

    Procedure/Surgery

    allogeneic HSCT

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: CHEMOTHERAPYOther 1 intervention
Group B: allogeneic HSCTOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time from diagnosis to death or last follow-up

Time frame
3 years

Secondary outcomes

1

Complete remission (CR) rate

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

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

Other outcomes

1

alloSCT realization

Proportion of patients who receive early or delayed alloHSCT

Time frame
Early alloHSCT: 15-20 weeks from diagnosis. Delayed: 30-35 weeks from diagnosis.

Sponsors and contacts

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

PETHEMA Foundation

Lead sponsor

Source ClinicalTrials.gov
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