Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

Conditions

• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bosutinib — DRUG
  Given PO
• Dasatinib — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Nilotinib — DRUG
  Given PO
• Ruxolitinib — DRUG
  Given PO
• Imatinib — DRUG
  Given PO

Study Details

This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.

Key Dates

Start date

Oct 24, 2018

Status verified

Oct 2025

Primary completion

Jul 1, 2024

Completion

Jul 1, 2028

Study Design

Enrollment

81 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (bosutinib, dasatinib, nilotinib, imatinib)
  Patients receive bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)
  Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of Molecular Response 4.5 (MR4.5) [ Time Frame: At 12 months ]

Locations (541)

Find similar trials in Anchorage, AK

Related Studies

• Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Personalized NK Cell Therapy in CBT
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas