Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/31/2019 |
| Start Date: | February 9, 2018 |
| End Date: | September 1, 2022 |
| Contact: | Maureen E Edgerly, R.N. |
| Email: | edgerlym@pbmac.nci.nih.gov |
| Phone: | (240) 760-6013 |
Phase 1b Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Background:
B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the
system that fights infections and disease. Researchers want to learn how certain drugs work
together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone,
obinutuzumab, and lenalidomide (ViPOR).
Objective:
To study the safety of ViPOR for people with B-cell lymphoma.
Eligibility:
People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after
treatment
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Tissue sample from previous procedure
- Imaging scans
- Registration for counseling on the risks of lenalidomide. They must get counseling at
least every 28 days.
Participants will have a bone marrow aspiration before treatment.
Participants may have tumor samples taken.
Participants will get ViPOR in 21-day cycles. For up to 6 cycles:
- Participants will get one drug by IV on days 1 and 2.
- Participants will take the other four drugs by mouth on most days. After their first
dose of venetoclax, they will stay in the clinic for at least 8 hours and return the
next day for monitoring. They may be admitted for more drugs or monitoring.
Participants will keep a drug diary.
Participants will have a physical exam and blood and urine tests at least once per cycle.
They will have scans 4 times over 6 cycles.
Participants will have a visit about 1 month after their last dose of study drug. They will
then have visits every few months for 3 years, and once a year for years 4 and 5. Visits
include a physical exam, blood tests, and scans.
B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the
system that fights infections and disease. Researchers want to learn how certain drugs work
together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone,
obinutuzumab, and lenalidomide (ViPOR).
Objective:
To study the safety of ViPOR for people with B-cell lymphoma.
Eligibility:
People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after
treatment
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Tissue sample from previous procedure
- Imaging scans
- Registration for counseling on the risks of lenalidomide. They must get counseling at
least every 28 days.
Participants will have a bone marrow aspiration before treatment.
Participants may have tumor samples taken.
Participants will get ViPOR in 21-day cycles. For up to 6 cycles:
- Participants will get one drug by IV on days 1 and 2.
- Participants will take the other four drugs by mouth on most days. After their first
dose of venetoclax, they will stay in the clinic for at least 8 hours and return the
next day for monitoring. They may be admitted for more drugs or monitoring.
Participants will keep a drug diary.
Participants will have a physical exam and blood and urine tests at least once per cycle.
They will have scans 4 times over 6 cycles.
Participants will have a visit about 1 month after their last dose of study drug. They will
then have visits every few months for 3 years, and once a year for years 4 and 5. Visits
include a physical exam, blood tests, and scans.
Background:
Combination chemotherapy with Rituximab has been the mainstay of treatment for CD20- positive
B-cell lymphomas
Significant advances have been made in curing aggressive B-cell lymphomas with
chemoimmunotherapy but indolent lymphomas and relapsed/refractory aggressive lymphomas remain
mostly incurable with chemotherapy alone
Targeted therapies aimed at disrupting key survival pathways in lymphoid malignancies are
emerging and showing significant activity in NHL in both the relapsed and first-line settings
Mechanistically-based combinations of targeted agents are likely to benefit patients who
cannot tolerate or who relapse after or are refractory to standard chemoimmunotherapy
ViPOR targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis); BTK
(B-cell receptor signaling and NFKB); Cereblon (NFKB) and CD20.
Objectives:
To determine the maximum tolerated dose (MTD) and the safety and toxicity profile of the
combination of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab and Revlimid in
relapsed/refractory B-cell malignancies
Eligibility:
Women and men greater than or equal to 18 years of age
ECOG performance status of less than or equal to 2
Histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma,
excluding MCL and CLL/SLL
Adequate organ function unless dysfunction secondary to lymphoma effect
Design:
Open-label, single-center, non-randomized phase 1b study
Standard 3 x 3 design will be used to determine the MTD of dose-escalated venetoclax with
fixed dose ibrutinib, prednisone, obinutuzumab and Revlimid with a small expansion cohort at
the MTD.
Maximum 6 cycles of combination targeted therapy every 21 days
To explore all dose levels, including further evaluation in a dose expansion of up to 20
additional patients at the MTD, the accrual ceiling will be set at 45 patients.
Combination chemotherapy with Rituximab has been the mainstay of treatment for CD20- positive
B-cell lymphomas
Significant advances have been made in curing aggressive B-cell lymphomas with
chemoimmunotherapy but indolent lymphomas and relapsed/refractory aggressive lymphomas remain
mostly incurable with chemotherapy alone
Targeted therapies aimed at disrupting key survival pathways in lymphoid malignancies are
emerging and showing significant activity in NHL in both the relapsed and first-line settings
Mechanistically-based combinations of targeted agents are likely to benefit patients who
cannot tolerate or who relapse after or are refractory to standard chemoimmunotherapy
ViPOR targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis); BTK
(B-cell receptor signaling and NFKB); Cereblon (NFKB) and CD20.
Objectives:
To determine the maximum tolerated dose (MTD) and the safety and toxicity profile of the
combination of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab and Revlimid in
relapsed/refractory B-cell malignancies
Eligibility:
Women and men greater than or equal to 18 years of age
ECOG performance status of less than or equal to 2
Histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma,
excluding MCL and CLL/SLL
Adequate organ function unless dysfunction secondary to lymphoma effect
Design:
Open-label, single-center, non-randomized phase 1b study
Standard 3 x 3 design will be used to determine the MTD of dose-escalated venetoclax with
fixed dose ibrutinib, prednisone, obinutuzumab and Revlimid with a small expansion cohort at
the MTD.
Maximum 6 cycles of combination targeted therapy every 21 days
To explore all dose levels, including further evaluation in a dose expansion of up to 20
additional patients at the MTD, the accrual ceiling will be set at 45 patients.
- ELIGIBILITY CRITERIA:
- Women and men greater than or equal to 18 years of age
- ECOG performance status of less than or equal to 2
- Histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma,
excluding MCL and CLL/SLL
- Adequate organ function unless dysfunction secondary to lymphoma effect
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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