Single-arm interventional study with ruxolitinib and AIOEP-BFM2017 chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.

Single-arm interventional study with ruxolitinib and AIOEP-BFM2017 chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway. - Rux-cALL-Pol 2020 trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005019-29-PL

Enrollment

Registered

2020-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Acute Lymphoblastic Leukemia with confirmed activating of JAK/STAT pathway in children and adolescents <18 years of age MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 22.0 Level: LLT Classification code 10072213 Term: JAK-2 mutation System Organ Class: 100000004850

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: MERCAPTOPURINE CAS Number: 50-44-2 Current Sponsor code: MP Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Newly diagnosed acute lymphoblastic leukemia treated according to AIEOP-BFM 2017 Poland protocol - Confirmed genetic lesion causing activation of JAK-STAT pathway (CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells` surface) - Stratification as early high risk according to AIEOP-BFM 2017 Poland: o no complete remission on day 33 OR o positivity for KMT2A-AFF1 OR o positivity for TCF3-HLF OR o hypodiploidy =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Events preventing continuation of therapy in accordance with AIEOP-BFM 2017 Poland protocol • ALL classified as a standard or intermediate risk (SR, MR) • Early high risk (eHR) ALL without genetic lesions within CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control;Secondary Objective: (2) Compare the rate of MRD(-) at TP1a in ruxolitinib + Consol. IB ext. to appropriate external control (3) Compare the change of absolute MRD count across TP1, TP1a and TP2 in ruxolitinib + Consol. IB ext. to that in appropriate external control (4) Compare EFS for ruxolitinib + Consol. IB ext. to appropriate external control (5) Compare OS for ruxolitinib + Consol. IB ext. to appropriate external control (6) Compare RFS for ruxolitinib + Consol. IB ext. to appropriate external control (7) Evaluate the safety and tolerability of ruxolitinib + Consol. IB ext. to appropriate external control ;Primary end point(s): (1) Proportion of patients with MRD(-)at TP2;Timepoint(s) of evaluation of this end point: After the respective MRD evaluation of the last patient in study	—

Measure

Time frame

Main Objective: Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control;Secondary Objective: (2) Compare the rate of MRD(-) at TP1a in ruxolitinib + Consol. IB ext. to appropriate external control (3) Compare the change of absolute MRD count across TP1, TP1a and TP2 in ruxolitinib + Consol. IB ext. to that in appropriate external control (4) Compare EFS for ruxolitinib + Consol. IB ext. to appropriate external control (5) Compare OS for ruxolitinib + Consol. IB ext. to appropriate external control (6) Compare RFS for ruxolitinib + Consol. IB ext. to appropriate external control (7) Evaluate the safety and tolerability of ruxolitinib + Consol. IB ext. to appropriate external control ;Primary end point(s): (1) Proportion of patients with MRD(-)at TP2;Timepoint(s) of evaluation of this end point: After the respective MRD evaluation of the last patient in study

—

Secondary

Measure	Time frame
Secondary end point(s): (2) Proportion of patients with MRD(-) at TP1a (3) Time to any of the following events: o Death from any cause o ALL relapse (including early and very early relapses) o Diagnosis of secondary malignancy. (4) Time to death from any cause (5) Time to relapse (including early and very early relapses) (6a) Frequency and grading of adverse events in experimental phases (number, percentage, number per patient-days, number per each grade of significance) (6b) Incidence of treatment-related adverse and severe adverse events;Timepoint(s) of evaluation of this end point: Survival, treatment-related mortality, AE and SAE: end of study MRD related endpoints: after the respective MRD evaluation of the last patient in study	—

Measure

Time frame

Secondary end point(s): (2) Proportion of patients with MRD(-) at TP1a (3) Time to any of the following events: o Death from any cause o ALL relapse (including early and very early relapses) o Diagnosis of secondary malignancy. (4) Time to death from any cause (5) Time to relapse (including early and very early relapses) (6a) Frequency and grading of adverse events in experimental phases (number, percentage, number per patient-days, number per each grade of significance) (6b) Incidence of treatment-related adverse and severe adverse events;Timepoint(s) of evaluation of this end point: Survival, treatment-related mortality, AE and SAE: end of study MRD related endpoints: after the respective MRD evaluation of the last patient in study

—

Countries

Poland

Contacts

Public ContactAcademic Research Organization

Clinical Trials Unit at the Medical University of Lodz

ireneusz.staron@umed.lodz.pl+48422725420

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026