A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06773195
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Ulixertinib — DRUG
    There are 3 planned dose levels of ulixertinib(450 mg BID, 300 mg BID, or 150 mg BID)
  • Ruxolitinib — DRUG
    Ruxolitinib for 28 day cycles.

Study Details

The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.

Key Dates

Start date
Jan 7, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JAK/MEK inhibition with Ruxolitinib and Ulixertinib
    Phase 1: There are 3 planned dose levels of ulixertinib (450 mg BID, 300 mg BID, or 150 mg BID) in combination with ruxolitinib for 28 day cycles. A 3+3 dose escalation design will be used to determine the RP2D of ulixertinib with ruxolitinib. Phase 2: Participants will be treated with ulixertinib at the RP2D determined from the phase 1 part of the study in combination with ruxolitinib for 28 day cycles.

Primary Outcome Measure

Dose Limiting Toxicity evaluable participants [ Time Frame: up to 28 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital (Data Collection Only)BostonMassachusetts02114
Gabriella Hobbs, MD
866-493-1612
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Raajit Rampal, MD,PhD
646-608-3746
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Raajit Rampal, MD, PhD
646-608-3746
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Raajit Rampal, MD, PhD
646-608-3746
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Raajit Rampa, MD, PhD
646-608-3746
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Raajit Rampal, MD, PhD
646-608-3746
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Raajit Rampal, MD, PhD
646-608-3746
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Raajit Rampal, MD, PhD
646-608-3746
Cleveland ClinicClevelandOhio44195
Aaron Gerds, MD
216-444-6833

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital (Data Collection Only)· Boston, MAMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY

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