Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT03878199
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Essential Thrombocythemia
  • Myelofibrosis
  • Myeloproliferative Neoplasm
  • Polycythemia Vera
  • Secondary Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic SCT
  • Liposome-encapsulated Daunorubicin-Cytarabine — DRUG
    Given IV
  • Ruxolitinib — DRUG
    Given PO

Study Details

This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.

Key Dates

Start date
Feb 20, 2019
Status verified
Apr 2026
Primary completion
Feb 27, 2025
Completion
Feb 27, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CPX-351, ruxolitinib, allogeneic SCT)
    See Detailed Description.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) (Phase I) [ Time Frame: Day 1 to day 42 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
OHSUPortlandOregon97239-
Simmons Cancer CenterDallasTexas75390-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OHOHSU· Portland, ORSimmons Cancer Center· Dallas, TX

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