Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients

Conditions

• Chronic Phase Chronic Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nilotinib — DRUG
  Participants will remain on the same dose of nilotinib they have been receiving prior to enrollment on the trial. This will range from 300 mg PO BID to 400 mg PO BID. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose of ruxolitinib, based on the number of dose.
• Ruxolitinib — DRUG
  Dose escalation will follow a 3+3 study design. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose, based on the number of dose limiting toxicities seen at a specific dose.

Study Details

This study is designed to determine the maximal tolerated dose of Ruxolitinib in combination with nilotinib in patients with chronic myeloid leukemia (CML).

Key Dates

Start date

Feb 21, 2013

Status verified

Jan 2021

Primary completion

Oct 17, 2016

Completion

Jan 9, 2019

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nilotinib with Ruxolitinib
  The starting dose of ruxolitinib will be 5mg by mouth (PO) twice a day (BID) and will increase by 5 mg increments in each cohort, to a maximum dose of 15 mg PO BID. Nilotinib will be given at a dose ranging from 300 mg PO BID to 400 mg PO BID, depending on the participant's dose prior to enrollment on the trial. Dose Level 1: Ruxolitinib 5 mg twice a day (BID); Nilotinib 300 mg or 400 mg BID. Dose Level 2: Ruxolitinib 10 mg BID; Nilotinib 300 mg or 400 mg BID. Dose Level 3: Ruxolitinib 15 mg BID; Nilotinib 300 mg or 400 mg BID.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: Average of 6 months ]

Locations (1)

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