Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:

Phase II Study Evaluating the Effect of Adding Bortezomib to Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03617484
• Other study ID #: UMCC 2018.046
• Secondary ID: HUM00139543
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2020
• Est. completion date: July 2030

Study information

• Verified date: June 2020
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2030
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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