Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

Withdrawn before enrolling · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT03617484

Run by

University of Michigan Rogel Cancer Center

People needed

0

Starts

2020-07-01

Expected to finish

2030-07-01

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

• 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

Where it is running

• University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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