CANDIDATE THERAPIES IN COMBINATION OR SEQUENTIALLY WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE: AN ADAPTIVE TRIAL BASED ON A DROP LOSER DESIGN - ACTIW STUDY

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516328-32-00

Acronym

P13/12

Enrollment

250

Registered

2024-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML)

Brief summary

The primary end-point is the cumulative incidence of patients achieving a deep molecular response defined by MR4.5 or deeper (BCR-ABLIS ≤ 0.0032 %) by 12 months.

Detailed description

Adverse events, The cumulative rate of patients achieving MR4.5 by 24, 36, 48 months in experimental and control arms, The cumulative rate of patients achieving MR4 by 12, 24, 36, 48 months in experimental and control arms, The cumulative rate of patients with undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms, The rate of patients in treatment free remission during follow-up, Measurement of number and clonogenicity of CML stem cells using the leukemic stem cell markers followed by flow cytometry analysis and the LTC-IC assay and others markers (ancillary study), Survival, progression free survival, event free survival, duration of response

Interventions

DRUGActos 15 mg tablets

DRUGAVELUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary end-point is the cumulative incidence of patients achieving a deep molecular response defined by MR4.5 or deeper (BCR-ABLIS ≤ 0.0032 %) by 12 months.	—

Secondary

Measure	Time frame
Adverse events, The cumulative rate of patients achieving MR4.5 by 24, 36, 48 months in experimental and control arms, The cumulative rate of patients achieving MR4 by 12, 24, 36, 48 months in experimental and control arms, The cumulative rate of patients with undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms, The rate of patients in treatment free remission during follow-up, Measurement of number and clonogenicity of CML stem cells using the leukemic stem cell markers followed by flow cytometry analysis and the LTC-IC assay and others markers (ancillary study), Survival, progression free survival, event free survival, duration of response	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026