Clinical trial NCT03617484: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Relapsed
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The proportion of participants that respond to treatment at 6 months
timeFrame: 6 Months
Secondary outcomes:
measure: Overall survival time
timeFrame: Up to 10 Years
measure: Progression free survival time
timeFrame: Up to 10 Years
measure: Best overall response
timeFrame: Up to 10 Years
measure: Rate of complete response
timeFrame: Up to 10 Years
measure: Time to progression
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Tycel Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: