Clinical Trials /

Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

NCT03617484

Description:

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.

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma
  • Official Title: Phase II Study Evaluating the Effect of Adding Bortezomib to Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2018.046
  • SECONDARY ID: HUM00139543
  • NCT ID: NCT03617484

Conditions

  • Mantle Cell Lymphoma

Interventions

DrugSynonymsArms
BortezomibBortezomib + Ibrutinib
IbrutinibBortezomib + Ibrutinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Bortezomib + IbrutinibExperimentalIbrutinib 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.
  • Bortezomib
  • Ibrutinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of participants that respond to treatment at 6 months
Time Frame:6 Months
Safety Issue:
Description:The primary endpoint is overall response rate (ORR). Participants will be evaluated for response based on the Lugano criteria.

Secondary Outcome Measures

Measure:Overall survival time
Time Frame:Up to 10 Years
Safety Issue:
Description:Patients will be followed for survival until death or up to 10 years.
Measure:Progression free survival time
Time Frame:Up to 10 Years
Safety Issue:
Description:Progression will be determined using the Lugano criteria. Patients will be followed for survival until death or up to 10 years.
Measure:Best overall response
Time Frame:Up to 10 Years
Safety Issue:
Description: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.
Measure:Rate of complete response
Time Frame:Up to 10 Years
Safety Issue:
Description:Participants will be evaluated for response based on the Lugano criteria. The percentage of participants who achieve CR after treatment.
Measure:Time to progression
Time Frame:Up to 10 Years
Safety Issue:
Description:Progression will be determined using the Lugano criteria.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Rogel Cancer Center

Trial Keywords

  • Relapsed

Last Updated

January 13, 2020