A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis

Part of paid clinical trials in Middletown, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03069326
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib will be given orally in an outpatient setting unless the patient is being seen inpatient for another reason. Ruxolitinib will be given continuously orally daily in 28-day cycles.
  • Thalidomide — DRUG
    Thalidomide will be given orally in an outpatient setting unless the patient is being seen inpatient for another reason. thalidomide will be given continuously orally daily in 28-day cycles.

Study Details

The purpose of this study is to test any good and bad effects of the study drugs called ruxolitinib and thalidomide. Ruxolitinib and thalidomide could shrink the cancer, but it could also cause side effects.

Key Dates

Start date
Feb 27, 2017
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Ruxolitinib and Thalidomide
    After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.
  • Experimental: Cohort B: Ruxolitinib and Thalidomide
    A cohort expansion, for patients with baseline thrombocytopenia, will enroll 35 additional patients After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.

Primary Outcome Measure

best objective response rate (ORR) [ Time Frame: 1 year ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Middletown, NJ

By research site
Memorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering Nassau· Uniondale, NY

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