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Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617484
Recruitment Status : Suspended (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.)
First Posted : August 6, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Bortezomib Drug: Ibrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Effect of Adding Bortezomib to Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Bortezomib + Ibrutinib

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.

Drug: Bortezomib
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.

Drug: Ibrutinib
Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival time [ Time Frame: Up to 10 Years ]
    Patients will be followed for survival until death or up to 10 years.

  2. Progression free survival time [ Time Frame: Up to 10 Years ]
    Progression will be determined using the Lugano criteria. Patients will be followed for survival until death or up to 10 years.

  3. Best overall response [ Time Frame: Up to 10 Years ]
    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.

  4. Rate of complete response [ Time Frame: Up to 10 Years ]
    Participants will be evaluated for response based on the Lugano criteria. The percentage of participants who achieve CR after treatment.

  5. Time to progression [ Time Frame: Up to 10 Years ]
    Progression will be determined using the Lugano criteria.



Information from the National Library of Medicine

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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:

  • 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.)

Exclusion Criteria:

  • 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

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): NCT03617484


Locations
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United States, Michigan
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48187
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Tycel Phillips, MD University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03617484    
Other Study ID Numbers: UMCC 2018.046
HUM00139543 ( Other Identifier: University of Michigan )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Michigan Rogel Cancer Center:
Relapsed
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents