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Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

ConditionsHigh Grade B-Cell Lymphoma With MYC and BCL6 RearrangementsRecurrent Diffuse Large B-Cell LymphomaRecurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRecurrent Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent T-Cell/Histiocyte-Rich Large B-Cell LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRefractory Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRefractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be ≥ 18 years of age

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)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo optional tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Ibrutinib

    Drug

    Given PO

  • Lenalidomide

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Obinutuzumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Prednisone

    Drug

    Given PO

  • Venetoclax

    Drug

    Given PO

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Treatment (ViPOR)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR) rate (CD10-negative diffuse large B cell lymphoma [DLBCL] and high grade B-cell lymphoma with MYC and BCL2 with or without BCL6 rearrangements [HGBCL-DH-BCL2])

Will be assessed using the Lugano Classification and will be defined as the complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.

Time frame
Up to 5 years

Secondary outcomes

1

CR rate (CD10-negative activated B-cell [ABC] and non-ABC DLBCL)

Estimates will be presented with 90% confidence intervals. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.

Time frame
Up to 5 years
2

Overall response rate

Estimates will be presented with 90% confidence intervals. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.

Time frame
Up to 5 years
3

Duration of response (DOR)

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize DOR. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Logistic/linear regression will be performed for binary/continuous endpoints variables.

Time frame
From the documented beginning of response to the time of relapse up to 10 years
4

Event-free survival (EFS)

Estimates will be presented with 90% confidence intervals. Kaplan-Meier method will be used to visualize EFS. Frequency and proportion will be used to describe variables on the nominal/ordinal scale, and measures of dispersion for interval/ratio variables. Multivariable analysis will be performed with Cox PH model and logistic/linear regression will be performed for binary/continuous endpoints variables.

Time frame
From study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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