Mantle Cell LymphomaPhase 2NCT03617484
Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma
A Phase 2 study testing Bortezomib and Ibrutinib in people with Mantle Cell Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a phase II study to evaluate the efficacy of ibrutinib in combination with bortezomib in in MCL (mantle cell lymphoma) patients who relapsed on single agent ibrutinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Bortezomib and Ibrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2020to Jul 2030
- Phase
- Phase 2
- 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
- Men and women ≥ 18 years of age
- Diagnosis of mantle cell lymphoma established by histologic assessment by a hemato-pathologist with additional assessment of the histologic diagnosis by immunohistochemistry or flow cytometry.
- Patients with history of MCL that has relapsed (documented disease progression after previously responding) to therapy (CR/PR) on single agent ibrutinib (treated for at least 6 months) as the last treatment prior to enrollment.
- Adequate liver, renal and bone marrow function
- Adequate coagulation (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
- Female subjects of childbearing potential must have a negative urine/serum pregnancy test upon study entry. Women as well are not advised to breastfeed during treatment with bortezomib and for 2 months after treatment.
- Male and female subjects of reproductive potential must agree to use both a highly effective method of birth control and barrier method during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males.
- Eastern Cooperative Oncology Group (ECOG) performance status of <2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
Who cannot join
- Concurrent diagnosis of another malignancy unless treated with curative intent more than 2 years from study start (basal/squamous cell carcinoma of the skin is not an exclusion).
- Previous treatment with bortezomib.
- Patients who are eligible for autologous stem cell transplant are excluded unless they refuse this procedure.
- History of allogeneic stem cell transplant.
- Other exclusions (certain concurrent conditions) per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48187
About this study
Official title: Phase II Study Evaluating the Effect of Adding Bortezomib to Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma
This is a phase II study to evaluate the efficacy of ibrutinib in combination with bortezomib in in MCL (mantle cell lymphoma) patients who relapsed on single agent ibrutinib.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Bortezomib, Ibrutinib
- Keywords
- Relapsed
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m^2 on days 1, 4, 8, and 11 of each 21-day cycle.
IbrutinibDrug
Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + Ibrutinib | Experimental | Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.
Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m^2 on days 1, 4, 8, and 11 of each 21-day cycle. Receives: Drug: Bortezomib; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants that respond to treatment at 6 months
The primary endpoint is overall response rate (ORR). Participants will be evaluated for response based on the Lugano criteria.
Measured: 6 Months
Secondary outcomes (5)
Overall survival time
Patients will be followed for survival until death or up to 10 years.
Measured: Up to 10 Years
Progression free survival time
Progression will be determined using the Lugano criteria. Patients will be followed for survival until death or up to 10 years.
Measured: Up to 10 Years
Best overall response
Participants will be evaluated for response based on the Lugano criteria. From the start of the study treatment until the disease progression/recurrence or up to 10 years.
Measured: Up to 10 Years
Rate of complete response
Participants will be evaluated for response based on the Lugano criteria. The percentage of participants who achieve CR after treatment.
Measured: Up to 10 Years
Time to progression
Progression will be determined using the Lugano criteria.
Measured: Up to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startJul 2020 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJul 2030 (estimated)
Why it stopped: Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tycel Phillips, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617484
- Sponsor's protocol ID
- UMCC 2018.046
- Other IDs
- HUM00139543
- Status last verified
- Jun 2020
- First submitted
- 31 Jul 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Effect of Adding Bortezomib to Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03617484
- Acronym / sponsor ID
- UMCC 2018.046
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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.
This is a phase II study to evaluate the efficacy of ibrutinib in combination with bortezomib in in MCL (mantle cell lymphoma) patients who relapsed on single agent ibrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib + Ibrutinib | Experimental | Drug: Bortezomib, Drug: IbrutinibIbrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle. Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m^2 on days 1, 4, 8, and 11 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥ 18 years of age
- Diagnosis of mantle cell lymphoma established by histologic assessment by a hemato-pathologist with additional assessment of the histologic diagnosis by immunohistochemistry or flow cytometry.
- Patients with history of MCL that has relapsed (documented disease progression after previously responding) to therapy (CR/PR) on single agent ibrutinib (treated for at least 6 months) as the last treatment prior to enrollment.
- Adequate liver, renal and bone marrow function
- Adequate coagulation (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
Key exclusion criteria (5 listed)
- Concurrent diagnosis of another malignancy unless treated with curative intent more than 2 years from study start (basal/squamous cell carcinoma of the skin is not an exclusion).
- Previous treatment with bortezomib.
- Patients who are eligible for autologous stem cell transplant are excluded unless they refuse this procedure.
- History of allogeneic stem cell transplant.
- Other exclusions (certain concurrent conditions) per protocol
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 |
|---|---|---|
| BortezomibBortezomib will be administered subcutaneously at a dose of 1.3 mg/m^2 on days 1, 4, 8, and 11 of each 21-day cycle. | Drug | Bortezomib + Ibrutinib |
| IbrutinibIbrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle. | Drug | Bortezomib + Ibrutinib |
Primary outcome
The proportion of participants that respond to treatment at 6 months
Time frame: 6 Months
The primary endpoint is overall response rate (ORR). Participants will be evaluated for response based on the Lugano criteria.
5 secondary outcomes
Overall survival time
Time frame: Up to 10 Years
Progression free survival time
Time frame: Up to 10 Years
Best overall response
Time frame: Up to 10 Years
Rate of complete response
Time frame: Up to 10 Years
Time to progression
Time frame: Up to 10 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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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, MD 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 2 study testing Bortezomib and Ibrutinib in people with Mantle Cell Lymphoma, 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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Jun 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 proportion of participants that respond to treatment at 6 months (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2020.