NCT02257138

Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia

Phase I/II Study of Ruxolitinib Plus Decitabine in Patients With Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of ruxolitinib phosphate when given together with decitabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or is not responding to treatment, or has developed from a type of bone marrow diseases called myeloproliferative neoplasms. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate together with decitabine may be an effective treatment for acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To determine the tolerability of the combination of decitabine and ruxolitinib phosphate (ruxolitinib \[DI\]) in patients with leukemia. (Phase I) II. To determine the efficacy of ruxolitinib in increasing and prolonging response induced by decitabine alone in patients with post myeloproliferative neoplasm acute myeloid leukemia (AML) (post MPN-AML) alternatively referred to as (myeloproliferative neoplasm - blast phase; MPN-BP). (Compared to historical response rate with decitabine alone) (Phase II) SECONDARY OBJECTIVES: I. To compare whether there is a difference in response rate patients with post-MPN AML with janus kinase 2 (JAK2) mutations and patients without JAK2 mutations. OUTLINE: This is a phase I, dose-escalation study of ruxolitinib phosphate followed by a phase II study. Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28 and decitabine intravenously (IV) over 1-2 hours on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Blasts More Than 20 Percent of Bone Marrow Nucleated Cells
• Blasts More Than 20 Percent of Peripheral Blood White Cells
• Myelodysplastic/Myeloproliferative Neoplasm
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Decitabine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Ruxolitinib Phosphate	Given PO

Timeline

• Start date: 2015-02-12
• Primary completion: 2021-03-19
• Completion: 2021-03-19
• First posted: 2014-10-06
• Last updated: 2025-06-08
• Results posted: 2022-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study