Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

NCT ID: NCT03617484

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2030-07-31

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.

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

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.

Ibrutinib

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Ibrutinib

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tycel Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00139543

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2018.046

Identifier Type: -

Identifier Source: org_study_id