Dose Escalation Study to Determine the Maximum Tolerated Dose of the Combination of Ruxolitinib and Bortezomib in Patients With Relapsed or Refractory Lymphoma
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|ClinicalTrials.gov Identifier: NCT02613598|
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Lymphoma Lymphoma, Non-Hodgkin||Drug: Bortezomib Drug: Ruxolitinib||Phase 1|
Treatment of relapsed and refractory Hodgkin and Non-Hodgkin's Lymphoma remains difficult. To improve upon current efficacy rates new treatment modalities are needed. Currently modalities based upon targeting specific pathway and molecular receptors have made the greatest impact in the outcomes of refractory patients.
The JAK-Stat pathway and NF-κB are two such targets that have been shown to fuel the malignant transformation and growth of both myeloma and lymphoma. Blockade of key points in these molecular pathways has the potential of halting the pro-survival machinery. Combined inhibition of JAK/Stat and NF-κB may lead to synergistic effects as well as possibly mitigating some of the mechanisms of resistance to either agent. In this proposal, the investigators aim to utilize the JAK/Stat inhibitor ruxolitinib (Jakafi) and proteasome inhibitor bortezomib (Velcade) to target two major pathways of malignant transformation in hematologic malignancies.
The primary objective of this research study is to determine the maximum tolerated dose (MTD) of Ruxolitinib (Jakafi) in combination with standard dose Bortezomib (Velcade) in patients with relapsed or refractory Hodgkin (HL) and Non-Hodgkin Lymphoma (NHL).
The University of Michigan will enroll 24 subjects. Eligible subjects will have histologically or cytologically confirmed Hodgkin and Non-hodgkin's Lymphoma excluding Burkitt, CLL and lymphoblastic lymphoma that is considered to have relapsed or to be refractory to primary chemotherapy. Any prior exposure to Jakafi is excluded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study to Determine the Maximum Tolerated Dose of the Combination of Ruxolitinib and Bortezomib in Patients With Relapsed or Refractory Lymphoma|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Bortezomib and Ruxolitinib
Bortezomib on days 1, 4, 8, and 11 of a 21 day cycle in combination with Ruxolitinib (5, 10, 15, 20, or 25 mg) twice daily.
Other Name: Velcade
Other Name: Jakafi
- The Maximum Tolerated Dose (MTD) of Ruxolitinib in Combination with Standard Dose Bortezomib [ Time Frame: Up to 5 Years ]
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): NCT02613598
|Contact: Tycel Phillips, M.D.||email@example.com|
|United States, Michigan|
|University of Michgan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48187|
|Contact: Tycel Phillips, M.D. 734-232-2883 firstname.lastname@example.org|
|Principal Investigator: Tycel Phillips, M.D.|
|Principal Investigator:||Tycel Phillips, M.D.||University of Michigan Rogel Cancer Center|