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Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
Phase 2 trial testing bortezomib in Contiguous Stage II Mantle Cell Lymphoma in 23 participants. Completed in 2 November 2020.
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 3 October 2011 |
| Primary completion | 2 November 2020 |
| Estimated completion | 2 November 2020 |
| Sites | 2 locations across United States |
City of Hope Medical Center
19 and older, any sex, with Contiguous Stage II Mantle Cell Lymphoma or Noncontiguous Stage II Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 90 | 66 – 97 |
Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 95 | 68 – 99 |
Observed toxicities will be summarized in terms of type, severity (graded by NCI CTCAE version 4.0) and attribution.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bortezomib and Rituximab) | 1 |
Time frame: Up to five years after initial treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Bortezomib and … |
|---|---|---|
| Fever | General disorders | — |
| Neutrophil Count Decreased | Investigations | — |
| Skin Infection | Infections and infestations | — |
| Wound Infection | Infections and infestations | — |
| Lung Infection | Infections and infestations | — |
| Myelodysplastic Syndrome | Blood and lymphatic system disorders | — |
| Human Metapneumovirus Infection | Infections and infestations | — |
| Febrile Neutropenia | Infections and infestations | — |
| Meningitis | Infections and infestations | — |
| Reaction | System | Treatment (Bortezomib and … |
|---|---|---|
| Fatigue | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Chills | General disorders | — |
| Injection site reaction | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Hearing impaired | Ear and labyrinth disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Paresthesia | Nervous system disorders | — |
| Tinnitus | Ear and labyrinth disorders | — |
| Pain | General disorders | — |
| Investigations - Other, specify | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | — |
| Anxiety | Psychiatric disorders | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Fever, Neutrophil Count Decreased, Skin Infection, Wound Infection, Lung Infection, Myelodysplastic Syndrome, Human Metapneumovirus Infection, Febrile Neutropenia.
Data from ClinicalTrials.gov NCT01267812 adverse events section.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together works in treating patients with mantle cell lymphoma who have previously undergone stem cell transplantation
4 peer-reviewed publications reference this trial (live from Europe PMC):
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