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Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

NCT01914484 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-11-02

No results posted yet for this study

Summary

This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor therapies with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase inhibitor blocking alternative pathway independent of BCR-ABL mediated pathway, thus having a potential to overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or ALL patients. Phase I study will be conducted to define a recommended phase II dose (RPTD) and phase II study will examine the hypothesis that combinational approach will increase response rate of resistant CML/ALL patients, thus evaluating efficacy of the combination regimen.

Conditions

  • Chronic Phase Chronic Myeloid Leukemia
  • Accelerated Phase Chronic Myeloid Leukemia
  • Blastic Phase Chronic Myeloid Leukemia
  • Philadelphia Positive Acute Lymphoblastic Leukemia
  • Resistant to Tyrosine Kinase Inhibitor Therapy

Interventions

DRUG

Nilotinib

Nilotinib dose will remain fixed at 400mg bid throughout the cycles. BCR-ABL kinase inhibitor

DRUG

Ruxolitinib

In the phase I part of the study, dose escalation will follow a 3+3 study design at either of 3 fixed dose levels (10 mg bid, 15 mg bid or 20 mg bid). No intra-patient dose-escalation will occur. JAK inhibitor

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Dennis Kim, MD/PhD · Princess Margaret Hospital, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

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 NCT01914484 on ClinicalTrials.gov