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Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy
Phase 2 trial testing Induction Venetoclax in Follicular Lymphoma in 56 participants. Completed in 6 January 2023.
| Lead sponsor | PrECOG, LLC. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 27 December 2017 |
| Primary completion | 3 May 2021 |
| Estimated completion | 6 January 2023 |
| Sites | 10 locations across United States |
PrECOG, LLC. — full company profile →
18 and older, any sex, with Follicular Lymphoma or Non-Hodgkin's Lymphoma Follicular. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
CR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 41 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 11 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 1 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 0 |
ORR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 52 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 4 |
Conversion to CR during Maintenance Therapy assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Venetoclax Maintenance | 4 | |
| Obinutuzumab + Venetoclax Maintenance | 3 | |
| Obinutuzumab + Venetoclax Maintenance | 4 |
PFS assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 87.5 | 75.3 – 93.9 |
OS assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 94.6 | 86.7 – 97.9 |
Number of participants with abnormal laboratory values and/or adverse events related to treatment of GRADE 3 or higher
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 47 |
Off treatment Reasons
| Group | Value | 95% CI |
|---|---|---|
| Obinutuzumab + Bendamustine + Venetoclax Induction | 34 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 12 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 1 | |
| Obinutuzumab + Bendamustine + Venetoclax Induction | 5 |
Time frame: Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Obinutuzumab + Bendamustin… |
|---|---|---|
| Tumor lysis syndrome | Investigations | — |
| Nausea | General disorders | — |
| Pyrexia | General disorders | — |
| Lung infection | Respiratory, thoracic and mediastinal disorders | — |
| Vomitting | Gastrointestinal disorders | — |
| Back pain | General disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Cellulitis | Skin and subcutaneous tissue disorders | — |
| Infusion related reaction | General disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Obinutuzumab + Bendamustin… |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Vomitting | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Headache | General disorders | — |
| Decreased appetite | Gastrointestinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Infusion related reaction | Blood and lymphatic system disorders | — |
| Hyperuricemia | Renal and urinary disorders | — |
| AST/ALT increase | Hepatobiliary disorders | — |
| Constipation | Gastrointestinal disorders | — |
Most-reported serious reactions: Tumor lysis syndrome, Nausea, Pyrexia, Lung infection, Vomitting, Back pain, Neutropenia, Cellulitis.
Data from ClinicalTrials.gov NCT03113422 adverse events section.
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma. As of 9/5/2018, a higher than expected incidence of tumor lysis syndrome (TLS) was experienced among patients receiving venetoclax, obinutuzumab and bendamustine on Cycle 1, Day 1 of treatment. TLS is caused by the fast breakdown of cancer cells. These patients developed an increase in some of their blood tests (uric acid, phosphorus, potassium and/or creatinine). They received a medication called rasburicase and continued with treatment. It is unclear if the TLS was due to the venetoclax or the standard treatment of obinutuzumab and bendamustine. For the remaining patients, venetoclax will start on Cycle 2, Day 1 (previously Cycle 1, Day 1). As of 9/16/2021, additional maintenance therapy has been suspended for those patients who remain on study. These patients will not receive any further treatment and will move on to the two year survival follow-up.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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