Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
UMCC 2018.046
- SECONDARY ID:
HUM00139543
- NCT ID:
NCT03617484
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Bortezomib | | Bortezomib + Ibrutinib |
Ibrutinib | | Bortezomib + Ibrutinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The proportion of participants that respond to treatment at 6 months |
Time Frame: | 6 Months |
Safety Issue: | |
Description: | The primary endpoint is overall response rate (ORR). Participants will be evaluated for response based on the Lugano criteria. |
Secondary Outcome Measures
Measure: | Overall survival time |
Time Frame: | Up to 10 Years |
Safety Issue: | |
Description: | Patients will be followed for survival until death or up to 10 years. |
Measure: | Progression free survival time |
Time Frame: | Up to 10 Years |
Safety Issue: | |
Description: | Progression will be determined using the Lugano criteria. Patients will be followed for survival until death or up to 10 years. |
Measure: | Best overall response |
Time Frame: | Up to 10 Years |
Safety Issue: | |
Description: | 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. |
Measure: | Rate of complete response |
Time Frame: | Up to 10 Years |
Safety Issue: | |
Description: | Participants will be evaluated for response based on the Lugano criteria. The percentage of participants who achieve CR after treatment. |
Measure: | Time to progression |
Time Frame: | Up to 10 Years |
Safety Issue: | |
Description: | Progression will be determined using the Lugano criteria. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | University of Michigan Rogel Cancer Center |
Trial Keywords
Last Updated
June 22, 2020