Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

NCT03617484 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: UMCC 2018.046HUM00139543
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Relapsed

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (5)

• Overall survival time

  Up to 10 Years

• Progression free survival time

  Up to 10 Years

• Best overall response

  Up to 10 Years

• Rate of complete response

  Up to 10 Years

• Time to progression

  Up to 10 Years

Study Arms (1)

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.

Drug: Bortezomib; Drug: Ibrutinib

Interventions

Bortezomib 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.

Bortezomib + Ibrutinib

Ibrutinib DRUG

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

Bortezomib + Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Recurrence

Interventions

Bortezomib; ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tycel Phillips, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: July 1, 2020
• Primary Completion: January 1, 2023
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)