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Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

ConditionsLymphomaNon-Hodgkin LymphomaDiffuse Large B-Cell LymphomaBurkitt Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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....

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).

CLL/SLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL/SLL compared to other non-Hodgkin lymphomas.

NOTE: Patients with known active CNS lymphoma are not eligible.

Relapsed and/or refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).

Disqualifiers

Patients who are actively receiving any other investigational agents.

Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug

Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug

Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • Venetoclax

    Drug

    Administered orally, days 2-14, at varying doses of 200-800 mg (based upon assigned dose level); every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

  • Ibrutinib

    Drug

    Administered orally, days 1-14, at a dose of 560 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

  • Prednisone

    Drug

    Administered orally, days 1-7, at a dose of 100 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

  • Obinutuzumab

    Biological/Vaccine

    Administered intravenously, days 1 and 2, at a dose of 1000 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

  • Revlimid (lenalidomide)

    Drug

    Administered orally, days 1-15, at a dose of 15 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

Treatment groups

155 Participants
are divided into 4 treatment groups
Group A: Arm 1: Dose EscalationExperimental treatment 5 interventions
Group B: Arm 2: Dose EscalationExperimental treatment 5 interventions
Group C: Arm 3: Dose ExpansionExperimental treatment 5 interventions
Group D: Arm 4: Dose ExpansionExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Number and grade of adverse events

Number and grade of adverse events

Time frame
22 days

Secondary outcomes

1

Progression-free survival (PFS)

Time from the date of study enrollment until the time of disease relapse, disease progression, or death, whichever occurs first, assessed every 3-6 months

Time frame
Time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first, assessed every 3-6 months
2

Overall survival (OS)

Time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months

Time frame
Time from the date of from initial diagnosis until death from any cause; assessed every 3-6 months
3

Overall response rate (ORR)

Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed every 3-6 months

Time frame
Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death, assessed every 3-6 months

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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