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

Conditions

• Leukemia, Chronic Myeloid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nilotinib — DRUG
  Nilotinib 300 mg BID
• Ruxolitinib — DRUG
  Ruxolitinib, 10, 15 or 20mg BID

Study Details

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.

Key Dates

Start date

Jan 31, 2018

Status verified

Feb 2021

Primary completion

Aug 31, 2021

Completion

Aug 31, 2021

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib [ Time Frame: 2 Years ]

Locations (2)

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