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

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ClinicalTrials.gov Identifier: NCT03069326
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Incyte Corporation
Celgene
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelofibrosis Drug: Ruxolitinib Drug: Thalidomide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a multicenter, two stage phase II trial designed to assess the effect of ruxolitinib and thalidomide combination in subjects with Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Ruxolitinib And Thalidomide Combination as a Therapy for Patients With Myelofibrosis
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: 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.
Drug: Ruxolitinib
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.

Drug: Thalidomide
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.




Primary Outcome Measures :
  1. best objective response rate (ORR) [ Time Frame: 1 year ]
    (ORR; complete response, partial response, and clinical improvement by IWG-MRT) in the first six cycles of the combination therapy. Clinical improvement for this endpoint will be defined as the change in anemia, spleen, and symptom response from the time of the initiation the combination therapy. The ORR will be defined as the best response by the completion of cycle 6 of combination therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of myelofibrosis (either primary or post essential thrombocythemia/polycythemia vera) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate-1 or -2 or high risk according to International Working Group (IWG) criteria.
  • Patients taking Ruxolitinib at the time of enrollment must have been taking Ruxolitinib for a minimum of 3 months, and must have been on a stable dose of Ruxolitinib for a minimum of 4 weeks immediately prior to enrollment.
  • Patients taking Ruxolitinib at the time of enrollment must be deemed to have had a suboptimal response (less than partial response per IWG criteria) to Ruxolitinib single-agent therapy or deemed to have progression of disease (per IWG criteria).
  • Age ≥ 18 years at the time of signing the informed consent.
  • ECOG performance status 0 to 2.
  • Patients must have adequate organ function as demonstrated by the following:

    1. Total bilirubin ≤ 2.0 mg/dL, unless due to Gilbert's disease
    2. Serum creatinine ≤ 2.0 mg/dL.
    3. ALT and AST ≤ 3 x upper limit of normal (unless the transaminitis is considered to be related to MF
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 14 days prior to and again within 24 hours* of starting Thalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking Thalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • All study participants must be registered into the mandatory REMS® program, and be willing and able to comply with the requirements of REMS®
  • Platelets ≥ 50000/uL and ANC ≥ 1000
  • All study participants must be able to swallow oral medication

Exclusion Criteria:

  • Use of any other standard anti-neoplastic drug or growth factor (e.g., anagrelide, G-CSF, revlimid, clofarabine) except hydroxyurea or experimental drugs, with the exception of Ruxolitinib, less than 14 days or 5-half lives prior to starting study therapy and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.
  • Known prior clinically relevant hypersensitivity reaction to Thalidomide, including the development of erythema nodosum if characterized by a desquamating rash.
  • Prior therapy with Thalidomide in combination with Ruxolitinib
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the study.
  • Lactating females.
  • Known positive for HIV or hepatitis B or C per institutional standard of care
  • Participants with prior history of thromboembolic disease (i.e. deep venous thrombosis (DVT) or pulmonary embolism (PE) within the last six months, as Thalidomide has demonstrated an increased risk of DVT or PE
  • Known to have a hypercoagulability syndrome (e.g.: antithrombin III, deficiency, anticardiolipin syndrome etc).
  • Concurrent use of any strong inducers or strong inhibitors of CYP3A4. (See Appendix F for a list of prohibited and cautionary CYP3A4 inhibitors and inducers)
  • Patients with active malignancy of other type than required for this study are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069326


Contacts
Contact: Raajit Rampal, MD, PhD 212-639-2194 rampalr@mskcc.org
Contact: Ellin Berman, MD 212-639-7762

Locations
United States, New Jersey
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Raajit Rampal, MD, PhD    212-639-2194      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Raajit Rampa, MD, PhD    212-639-2194      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Raajit Rampal, MD, PhD    212-639-2194      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Raajit Rampal, MD, PhD    212-639-2194      
Contact: Ellin Berman, MD    212-639-7762      
Principal Investigator: Raajit Rampal, MD, PhD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Raajit Rampal, MD, PhD    212-639-2194      
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Prithvira Bose, MD    713-792-7747      
Principal Investigator: Prithvira Bose, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Incyte Corporation
Celgene
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Raajit Rampal, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03069326     History of Changes
Other Study ID Numbers: 16-1498
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Ruxolitinib
Thalidomide
16-1498

Additional relevant MeSH terms:
Thalidomide
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents