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Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Phase 2 trial testing Polatuzumab Vedotin in Recurrent B-Cell Non-Hodgkin Lymphoma in 3 participants. Terminated before completion.
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 1 April 2021 |
| Primary completion | 28 March 2024 |
| Estimated completion | 29 March 2024 |
| Sites | 5 locations across United States |
Academic and Community Cancer Research United — full company profile →
18 and older, any sex, with Recurrent B-Cell Non-Hodgkin Lymphoma or Recurrent Grade 1 Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective status of CR measured by positron emission tomography (PET)-computed tomography (CT) scans according to Lugano 2014.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 |
The ORR at the end of induction will be estimated by the total number of patients who achieve a complete response (CR) or partial response (PR) by PET-CT scans according to Lugano 2014 divided by the total number of evaluable patients. The ORR between ibrutinib-naive and ibrutinib-pretreated patients will be compared using Fisher's exact test.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 0 |
The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS between ibrutinib-naive and ibrutinib-pretreated patients will be compared using log-rank test.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 5.5 | 1.1 – NA |
The distribution of OS will be estimated using the method of Kaplan-Meier. The OS between ibrutinib-naive and ibrutinib-pretreated patients will be compared using log-rank test.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | NA | 1.1 – NA |
All AEs occurring on or after first study treatment will be summarized by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 grade.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Rituximab, Polatuzumab Vedotin, Venetoclax) | 3 |
Time frame: 15 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Rituximab, Pola… |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Disease Progression | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Platelet count decreased | Investigations | — |
| Tumor lysis syndrome | Metabolism and nutrition disorders | — |
| Lung infection | Infections and infestations | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment (Rituximab, Pola… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Blood lactate dehydrogenase increased | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Cholesterol high | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Fever | General disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| GGT increased | Investigations | — |
| Headache | Nervous system disorders | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Insomnia | Psychiatric disorders | — |
| Lymph node pain | Blood and lymphatic system disorders | — |
| Malaise | General disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Paresthesia | Nervous system disorders | — |
| Peripheral motor neuropathy | Nervous system disorders | — |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Neutrophil count decreased, White blood cell decreased, Hypoxia, Anemia, Disease Progression, Dyspnea, Platelet count decreased, Tumor lysis syndrome.
Data from ClinicalTrials.gov NCT04659044 adverse events section.
This phase II trial studies the effect of polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cell growth. Rituximab hyaluronidase is a combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. Giving polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human may work better than standard therapy in treating patients with mantle cell lymphoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04659044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing