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A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML

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ClinicalTrials.gov Identifier: NCT02973711
Recruitment Status : Withdrawn (lack of funding)
First Posted : November 25, 2016
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This study combines two drugs (ruxolitinib and the tyrosine kinase inhibitor, nilotinib) in an attempt to eliminate the CML (Chronic Myeloid Leukemia) stem cell population and thus allow for the deepest and most durable response possible in patients with CML in chronic phase who have achieved a complete hematologic remission (CHR), complete cytogenetic remission (CCyR), and major molecular remission (MMR), but not a complete molecular remission (CMR). The study will look at safety and tolerability of ruxolitinib when combined with nilotinib in a phase I study and will help establish the MTD (Maximum Tolerated Dose) of ruxolitinib when combined with nilotinib. Once the optimal dose of ruxolitinib is established in the phase I setting, a phase II evaluation will seek to establish the efficacy of this combination.

Condition or disease Intervention/treatment Phase
Leukemia, Chronic Myeloid Drug: Nilotinib Drug: Ruxolitinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML Who Have Achieved a Complete Hematologic Remission, Complete Cytogenetic Remission, and Major Molecular Remission, But Not a Complete Molecular Remission on a Tyrosine Kinase Inhibitor Alone.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Nilotinib + Ruxolitinib

The first part of the trial will be Phase I and will enroll 25 participants. Participants will receive nilotinib BID and either 10, 15 or 20 mg of ruxolitinib BID. Maximum tolerated dose (MTD) of ruxolitinib will be determined.

The second part of the trial will be a Phase II and will enroll 25 subjects. Participants will receive nilotinib and the MTD of ruxolitinib.

Drug: Nilotinib
Nilotinib 300 mg BID

Drug: Ruxolitinib
Ruxolitinib, 10, 15 or 20mg BID




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib [ Time Frame: 2 Years ]
    Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib

  2. The number of patients that achieve a Complete Molecular Response (CMR) [ Time Frame: 2 Years ]
    CMR is defined as an absence of the BCR-ABL1 transcript by qPCR performed on peripheral blood or bone marrow aspirate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • ECOG (Eastern Cooperative Oncology Group) Performance Status 0, 1, or 2
  • Must have a diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, with no previous evidence of accelerated or blast-phase disease.
  • Must be actively receiving treatment for their CML with a tyrosine kinase inhibitor (TKI): imatinib, dasatinib, nilotinib or bosutinib, and must be on stable dose for > 1 year.
  • Must have an ongoing complete hematologic response (CHR) on a TKI
  • Must have an ongoing complete cytogenetic response (CCyR) on a TKI
  • Must be in a major molecular remission (MMR) on a TKI for a minimum of 1 year leading up to enrollment.
  • Adequate end organ function
  • Adequate electrolytes
  • Adequate platelet count
  • Adequate neutrophil count
  • Written informed consent prior to any screening procedures

Exclusion Criteria:

  • Patients in complete molecular remission (CMR) on a TKI.
  • Patients who have failed nilotinib or not tolerated nilotinib in the past
  • Certain cardiovascular disorders
  • Currently receiving treatment with strong CYP3A4 inhibitors which cannot be discontinued prior to starting study drug
  • Actively receiving herbal medicines that are strong CYP3A4 inhibitors and/or inducers and treatment cannot be discontinued prior to starting study drug
  • Currently receiving treatment with any medications that have the potential to prolong the QT interval that cannot be discontinued prior to starting study drug
  • Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the drug
  • Acute or chronic pancreatic disease within the last year
  • Cytopathologically confirmed Central Nervous System (CNS) infiltration
  • Another primary malignancy that requires systemic chemotherapy or radiation
  • Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
  • History of significant congenital or acquired bleeding disorder unrelated to cancer
  • Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
  • Past treatment with ruxolitinib
  • Treatment with other investigational agent within 30 days of Day 1
  • Inability to grant consent or history of non-compliance to medical regimens
  • Women who are breastfeeding
  • Women of child-bearing potential, unless they are using highly effective contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973711


Locations
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United States, Michigan
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Patrick Burke, M.D. University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02973711    
Other Study ID Numbers: UMCC 2015.103
HUM00122063 ( Other Identifier: University of Michigan )
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myeloid, Chronic-Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases