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Clinical Trials/CTRI/2021/02/031251
CTRI/2021/02/031251
Recruiting
Phase 1

Phase I study to evaluate the feasibility and safety of addition of ruxolitinib to a standard BFM-90 regimen in adolescent/adult Ph-like A

Tata Research Administrative Council TRAC0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Tata Research Administrative Council TRAC
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Tata Research Administrative Council TRAC

Eligibility Criteria

Inclusion Criteria

  • •1\. Newly diagnosed Ph\-like B cell precursor acute lymphoblastic leukemia
  • •2\. Diagnostic bone marrow or peripheral blood sample must demonstrate a Ph\-like expression profile with 1 of the following genetic lesions\-
  • •a\-CRLF2 overexpression by flow cytometry( \>10%)
  • •b\-CRLF2 rearrangement with fusion partners(IGH,P2RY8\) or
  • •c\-JAK2 rearrangement
  • •d\-EPOR rearrangement
  • •e\-PAX5 rearrangement
  • •f\-Other JAK pathway alterations ( eg g, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) as detected by targeted RNA sequencing.
  • •3\. ECOG PS 0\-3
  • •4\. Patients must have adequate organ and marrow function as defined below

Exclusion Criteria

  • •1\.Patients who test positive for Ph \+ve (BCR\-ABL 1\) / ETV6\-RUNX1 / TCF3\-PBX1 / MLL rearrangements / High hyperdiploidy by FISH/Conventional karyotyping
  • •2\.Seropositivity (HIV)\- Patients receiving anti\-retroviral therapy
  • •3\.Active replication of Hepatitis B virus / Hepatitis C virus
  • •4\.Uncontrolled comorbidities (Hypertension / Diabetes Mellitus / Seizures)
  • •5\.Pregnant patients
  • •6\.Active uncontrolled infection
  • •7\.Usage of strong CYP3A4 inhibitors within 5 half lives before first dose of study drug

Outcomes

Primary Outcomes

Not specified

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