Hodgkin's LymphomaPhase 1NCT02613598

Dose Escalation Study to Determine the Maximum Tolerated Dose of the Combination of Ruxolitinib and Bortezomib in Patients With Relapsed or Refractory Lymphoma

A Phase 1 study testing Bortezomib and Ruxolitinib in people with Hodgkin's Lymphoma and Lymphoma, Non-Hodgkin, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hodgkin's Lymphoma, Lymphoma, Non-Hodgkin
What is being tested?: Bortezomib and Ruxolitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 12 May 2016to 7 Jun 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Women and men with histologically or cytologically confirmed Hodgkin and all NHL subtypes excluding Burkitt, CLL and lymphoblastic lymphoma that is considered to have relapsed or to be refractory to primary chemotherapy.
No previous anti-cancer therapy for at least 21 days and recovered from all treatment related toxicity
Prior radiation is allowed prior to study start (1st dose of study medication) if at least 21 days have elapsed since prior large-field radiation therapy and all treatment related toxicity has resolved. At least 3 months must have passed since radio-immunotherapy.
Prior auto graft is allowed prior to study start (1st dose of study medication), but patients must be at least 3 months from date of stem cell infusion and have recovered to ≤ grade 1 toxicities related to this procedure.
Prior allogeneic transplants is allowed prior to study start (1st dose of study medication), but patients must be at least 6 months from date of stem cell infusion, have no evidence of GVHD, be off all immunosuppressant medications, and have recovered to ≤ grade 1 toxicities related to this procedure.
Age >18 years

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ECOG (Eastern Cooperative Oncology Group) Performance status ≤2
Life expectancy without treatment > 12 weeks
Patients must have adequate hematologic, hepatic, and renal function as defined as: Absolute neutrophil count ≥1,000/μl, Platelets ≥75,000/μl, (50,000/ μl if due to BM involvement), Direct bilirubin< 1.5 mg/dl, unless due to Gilbert's or secondary to hemolysis, AST (Aspartate Aminotransferase) and/or ALT (Alanine Transaminase) <2.5 X institutional upper limit of normal unless due to lymphomatous involvement of the liver, Creatinine < 1.5 mg/dl and/or creatinine clearance >60 mL/min using the Cockcroft-Gault formula and no symptoms attributable to grade 2 or higher peripheral neuropathy.
Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Patients who are currently receiving any other experimental agent, patients must have stopped other experimental agents at least 21 days prior to 1st study dose.
Any prior to exposure to Jakafi
Patients with untreated brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Jakafi or Velcade.
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breastfeeding women are excluded from this study because Jakafi is inhibitor of the Jak-1 and Jak-2 kinases with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with Jakafi, breastfeeding should be discontinued if the mother is treated with Jakafi. These potential risks may also apply to other agents used in this study.

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HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Jakafi. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Patients with grade 2 or higher peripheral neuropathy are excluded.
Patients with CLL (Chronic Lymphocytic Leukemia), Burkitt or lymphoblastic lymphoma are excluded.
Patients who would be required to concurrently take ruxolitinib in conjunction with a strong CYP3A4 inhibitors and have a platelet count less than 100,000 are ineligible for the study.
Patient who are required to take a strong CYP3A4 inducer are excluded from the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michgan Comprehensive Cancer Center
Ann Arbor, Michigan, 48187

Other trials in United States

About this study

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

Read the detailed description

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 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.

Conditions: Hodgkin's Lymphoma, Lymphoma, Non-Hodgkin
Being tested: Bortezomib, Ruxolitinib
Medical subject headings: Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BortezomibDrug
Also called Velcade
RuxolitinibDrug
Also called Jakafi

Study groups in NCT02613598
Study group	Role	What they receive
Bortezomib and Ruxolitinib	Experimental	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. Receives: Drug: Bortezomib; Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

The Maximum Tolerated Dose (MTD) of Ruxolitinib in Combination with Standard Dose Bortezomib
Measured: Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 20167 Jun 2021

First posted24 Nov 2015 (estimated)
Study start12 May 2016
Primary completion7 Jun 2021
Study completion7 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02613598
Sponsor's protocol ID: UMCC 2014.066
Other IDs: HUM00104716
Status last verified: Dec 2021
First submitted: 20 Nov 2015
Last updated: 20 Dec 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Active, not recruitingPhase 2
Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
Ann Arbor Stage I Hodgkin Lymphoma, Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma

All Hodgkin's Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02613598
Acronym / sponsor ID: UMCC 2014.066
Conditions: Hodgkin's Lymphoma, Lymphoma, Non-Hodgkin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of Michigan Rogel Cancer CenterUniversity, hospital or other
Study start: 12 May 2016 (actual)
Primary completion: 7 Jun 2021 (actual)
Study completion: 7 Jun 2021 (actual)
First posted: 24 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bortezomib and Ruxolitinib	Experimental	Drug: Bortezomib, Drug: RuxolitinibBortezomib 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Women and men with histologically or cytologically confirmed Hodgkin and all NHL subtypes excluding Burkitt, CLL and lymphoblastic lymphoma that is considered to have relapsed or to be refractory to primary chemotherapy.
No previous anti-cancer therapy for at least 21 days and recovered from all treatment related toxicity
Prior radiation is allowed prior to study start (1st dose of study medication) if at least 21 days have elapsed since prior large-field radiation therapy and all treatment related toxicity has resolved. At least 3 months must have passed since radio-immunotherapy.
Prior auto graft is allowed prior to study start (1st dose of study medication), but patients must be at least 3 months from date of stem cell infusion and have recovered to ≤ grade 1 toxicities related to this procedure.
Prior allogeneic transplants is allowed prior to study start (1st dose of study medication), but patients must be at least 6 months from date of stem cell infusion, have no evidence of GVHD, be off all immunosuppressant medications, and have recovered to ≤ grade 1 toxicities related to this procedure.

Key exclusion criteria (11 listed)

Patients who are currently receiving any other experimental agent, patients must have stopped other experimental agents at least 21 days prior to 1st study dose.
Any prior to exposure to Jakafi
Patients with untreated brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Jakafi or Velcade.
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BortezomibAlso: Velcade	Drug	Bortezomib and Ruxolitinib
RuxolitinibAlso: Jakafi	Drug	Bortezomib and Ruxolitinib

Primary outcome

The Maximum Tolerated Dose (MTD) of Ruxolitinib in Combination with Standard Dose Bortezomib
Time frame: Up to 5 Years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.

Related trials for Hodgkin's Lymphoma

RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Active, not recruitingPhase 2
Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
Ann Arbor Stage I Hodgkin Lymphoma, Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tycel Phillips, M.D. principal investigator

University of Michigan Rogel Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib and Ruxolitinib in people with Hodgkin's Lymphoma and Lymphoma, Non-Hodgkin, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Maximum Tolerated Dose (MTD) of Ruxolitinib in Combination with Standard Dose Bortezomib (time frame: Up to 5 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.