A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)
National Cancer Institute (NCI)
Summary
This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.
Description
PRIMARY OBJECTIVES: I. To evaluate the complete response (CR) rate of ViPOR in relapsed/refractory (R/R): Ia. CD10-negative DLBCL; and Ib. CD10-positive or negative high-grade B-cell lymphoma (HGBCL) with MYC and BCL2 (with or without BCL6) translocations (HGBCL-double hit \[DH\]-BCL2). SECONDARY OBJECTIVES: I. To evaluate the complete response (CR) rate of ViPOR in relapsed/refractory (R/R): Ia. CD10-negative activated B-cell (ABC) DLBCL; and Ib. CD10-negative non-ABC (i.e., unclassified or germinal center B-cell \[GCB\]) DLBCL. II. To evaluate the overall response rate (ORR), duration…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be ≥ 18 years of age * Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows: * Cohort 1: CD10-negative DLBCL, which includes: * CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL) * CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL) * CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6) * CD10-negative HGBCL, NOS (without MYC and BCL2 translocations) * CD10-negative T-cell/histiocyte-rich large B-…
Interventions
- ProcedureBiopsy Procedure
Undergo optional tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- ProcedureComputed Tomography
Undergo CT
- DrugIbrutinib
Given PO
- DrugLenalidomide
Locations (83)
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- Cedars-Sinai Medical CenterLos Angeles, California
- Smilow Cancer Hospital-Derby Care CenterDerby, Connecticut
- Smilow Cancer Hospital Care Center - GuilfordGuilford, Connecticut
- Yale UniversityNew Haven, Connecticut