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Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT

NCT06061094 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-04-29

No results posted yet for this study

Summary

The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation.

The EVOLVE trial aims to answer three questions challenging the current SoC:

Use of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).

In MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II).

In MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).

Conditions

  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Interventions

DRUG

Imatinib

Imatinib 600mg QD plus Chemotherapy

DRUG

Ponatinib

Ponatinib 45 mg QD plus chemotherapy

DRUG

Blinatumomab

Patients with molecular failure or intermediate response receive one cycle Blinatumomab before SCT; Patients with molecular CR randomized to the experimental arm receive 3 cycles Blinatumomab + chemotherapy

OTHER

Indication for stem cell transplantation

Patients with molecular CR randomized to the standard arm have an indication for SCT; patients with molecular failure or intermediate response have an indication for SCT. SCT is not part of the trial.

Sponsors & Collaborators

  • Deutsche Leukämie- & Lymphom-Hilfe

    collaborator UNKNOWN

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Goethe University

    lead OTHER

Principal Investigators

  • Nicola Goekbuget, MD · Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany

  • Fabian Lang, MD · Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany

  • Heike Pfeifer, MD · Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2029-07-01
Completion
2029-07-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT06061094 on ClinicalTrials.gov