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

Phase 1

• Conditions: Acute Lymphoblastic Leukemia with confirmed activating of JAK/STAT pathway in children and adolescents <18 years of age; MedDRA version: 22.0Level: LLTClassification code 10072213Term: JAK-2 mutationSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864

• Registration Number: EUCTR2020-005019-29-PL
• Lead Sponsor: Medical University of Lodz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-13
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 30

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:
ono complete remission on day 33 OR
opositivity for KMT2A-AFF1 OR
opositivity for TCF3-HLF OR
ohypodiploidy <45 chromosomes OR
oFCM-MRD in bone marrow on day 15 = 10% and not ETV6-RUNX1 positive OR
oIKZF1pls and PCR-MRD at TP1 positive or inconclusive and not positive for ETV6-RUNX1, TCF3-PBX1 or KMT2A rearr. other than KMT2A-AFF1 OR
oPCR-MRD at TP1 = 5x10-4 OR
oage < 1 year and any KMT2A rearrangement
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified