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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02973711
Other study ID # UMCC 2015.103
Secondary ID HUM00122063
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2018
Est. completion date August 2021

Study information

Verified date February 2021
Source University of Michigan Rogel Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nilotinib
Nilotinib 300 mg BID
Ruxolitinib
Ruxolitinib, 10, 15 or 20mg BID

Locations

Country Name City State
United States The University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib 2 Years
Primary The number of patients that achieve a Complete Molecular Response (CMR) CMR is defined as an absence of the BCR-ABL1 transcript by qPCR performed on peripheral blood or bone marrow aspirate. 2 Years
See also
  Status Clinical Trial Phase
Completed NCT04384848 - The EMPATHY Pilot Study N/A
Recruiting NCT03515018 - Evaluation of the Therapeutic Effect of HU Pulse Therapy for CML Patients Phase 3
Active, not recruiting NCT02381379 - Malaysia Stop Tyrosine Kinase Inhibitor Trial Phase 3
Active, not recruiting NCT02852486 - Study of Imatinib Discontinuation in Chronic Myeloid Leukemia With Deep Molecular Response Phase 2
Recruiting NCT02326311 - Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response Phase 3
Terminated NCT02627573 - Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT Phase 2
Terminated NCT01761695 - Chronic Myelod Leukemia Registry at Asan Medical Center
Not yet recruiting NCT02389920 - Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib Phase 4