A Phase 2 interventional study of Bendamustine and Obinutuzumab in Mantle Cell Lymphoma, Non-hodgkin Lymphoma and Non Hodgkin Lymphoma, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
This is a phase II single-arm, open-label, multicenter study evaluating the efficacy and safety of the combination of induction chemoimmunotherapy with bendamustine and obinutuzumab (BO) followed by consolidation therapy and maintenance therapy with obinutuzumab in subjects who have not received prior cytotoxic chemotherapy for their Mantle Cell Lymphoma (MCL) (i.e., prior single agent rituximab is permitted, prior involved-field radiotherapy is permitted).
This is a phase II single-arm, open-label, multicenter study evaluating the efficacy and safety of the combination of induction chemoimmunotherapy with bendamustine and obinutuzumab (BO) followed by consolidation therapy and maintenance therapy with obinutuzumab in subjects who have not received prior cytotoxic chemotherapy for their MCL (i.e., prior single-agent rituximab is permitted, prior involved-field radiotherapy is permitted). Therapy for individual subjects will be risk-adapted based on results of minimal residual disease (MRD) testing performed after the consolidation phase. The study will be carried out at the University of Wisconsin Carbone Cancer Center (UWCCC) and participating community and academic practice sites within the Wisconsin Oncology Network (WON). There will be 6-10 sites participating in this study.
The subject participation will include a screening period, treatment period, and a follow-up period. The induction chemoimmunotherapy regimen consists of bendamustine and obinutuzumab for 4-6 cycles, followed by consolidation and maintenance therapy with obinutuzumab in subjects achieving an objective response to induction therapy (i.e., complete or partial response; stable disease with objective evidence of tumor shrinkage. Subjects who are MRD-negative (determined by MRD testing on bone marrow and PB) after consolidation therapy will omit maintenance therapy.
Subjects will undergo disease reassessment after C4 of induction BO chemoimmunotherapy, after obinutuzumab consolidation therapy, and after C4 and C8 of maintenance obinutuzumab. MRD testing will be done after C2 of induction (PB only), after consolidation (BMA and PB), and post-maintenance or end of treatment (EOT) (PB only).
1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.
This study's enrollment of 21 is below the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must meet one of the following criteria:
Not eligible for more intensive cytotoxic chemotherapy or consolidative stem cell transplant based on one or more of the following:
heart or lung comorbidities, as reflected by at least 1 of the following:
OR
Laboratory test results within these ranges:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Induction chemoimmunotherapy (28 day cycles): Bendamustine 90 mg/m2 IV days 1 \& 2 every 28 days X 4-6 cycles Obinutuzumab: * Cycle 1: 100 mg IV day 1, 900 mg IV day 2, 1000 mg IV days 8 \& 15 * Cycles 2-6: 1000 mg IV day 1 Consolidation phase: Obinutuzumab 1000 mg IV weekly X 4 doses Maintenance phase (8 week cycles): Obinutuzumab 1000 mg IV on day 1 of cycles 1-8
Drug: Bendamustine · Drug: Obinutuzumab
Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of chronic lymphocytic leukemia (CLL) and for indolent B cell non-Hodgkin lymphomas (NHLs) progressing during or within 6 months of rituximab or a rituximab - containing regimen.
Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 monoclonal antibody (mAb).
Also known as: GA101, RO5072759
Progression Free Survival (PFS) at 2 Years
For each patient, progression-free survival (PFS) is measured from cycle 1 day 1 (C1D1) of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 2-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, participants will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 2 years are reported here.
Time frame: Up to 2 years
Minimal Residual Disease (MRD) Status
MRD defined as reduction to \>=10\^-6 fold reduction in the IgVH unique clone of mantle cell lymphoma (MCL) by next generation (NGS). MRD status will be evaluated after 2 cycles of induction chemoimmunotherapy with bendamustine and obinutuzumab, after 4 cycles of consolidation with obinutuzumab, and after an additional 8 cycles of maintenance with obinutuzumab. MRD status will be summarized using frequency and proportion with 95% confidence intervals. MRD status will be collected on peripheral blood after cycle 2 of induction therapy, on peripheral blood and bone marrow aspirate after consolidation obinutuzumab, and peripheral blood after maintenance therapy completion.
Time frame: At the end of Cycle 2 of induction therapy (each cycle is 28 days), following consolidation phase (after 6 cycles of induction, consolidation is 4 weekly doses of obinutuzumab), within 30 days of completing protocol therapy (up to 15 months total)
Estimate the Concordance Rate Between Peripheral Blood (PB) and Bone Marrow Aspirates (BMA) in Predicting MRD Status.
Concordance between PB and BMA in predicting MRD negative status will be summarized by percent of subjects in which MRD status is concordant (i.e., both positive in the PB and BMA or both negative in the PB and BMA).
Time frame: At the end of Cycle 2 of induction therapy (each cycle is 28 days), following consolidation phase of therapy (after 6 cycles of induction, consolidation is 4 weekly doses of obinutuzumab), and within 30 days of completing protocol therapy
Determine Objective Response Rates (CR + PR) With Induction Bendamustine and Obinutuzumab (BO) in Previously Untreated MCL Using the Lugano Classification for Response in Lymphoma
Lugano criteria will be used to assess radiographic response by CT and/or positron emission tomography (PET) imaging. Imaging for response assessment will be performed after 4 cycles of induction therapy, after consolidation obinutuzumab, and after cycles 4 and 8 of maintenance obinutuzumab. Bone marrow biopsy will be performed verify complete responses. Assessed as the best response over the course of therapy from any of the following time points: at the end of induction cycle 4 (each cycle is 28 days), after consolidation therapy (post-induction, consolidation is 4 weekly doses Obinutuzumab), and after Cycles 4 and 8 of Maintenance Obinutuzumab (each cycle is 8 weeks).
Time frame: Assessed up to cycle 8 of maintenance therapy, up to 15 months on study
Overall Survival (OS)
For a given participant, OS will be measured from C1D1 of the induction chemoimmunotherapy to the day the subject dies. Survival times of subjects who are still alive at the end of the follow-up period will be censored. OS will be summarized using point estimate of the median OS, along with the 95% confidence interval.
Time frame: Up to 3 years
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 During Therapy Induction BO Chemoimmunotherapy and Obinutuzumab Consolidation and Maintenance
Count of toxicities from the initiation of study treatment until 30 days following the last administration of study treatment or study discontinuation/termination; after this period, only serious adverse events (SAEs) that are possibly, probably, or definitely attributed will be reported. For a given subject, toxicities will be assessed from the time of C1D1 of study therapy until 30 days after completion of final dose of study-related treatment.
Time frame: Up to 25 months (until 30 days after completion of final dose of study-related treatment)
Participants were enrolled at UW Hospital and Clinics in Madison, WI, UW Cancer Center at ProHealth in Waukesha, WI, and St. Vincent Regional Cancer Center in Green Bay, WI from September 2017 to January 2022.
| Milestone | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Started | 21 |
| Induction chemotherapy cycle 4 | 21 |
| Completed | 20 |
| Not completed | 1 |
| Withdrew: Death | 1 |
| Milestone | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
| Milestone | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Started | 20 |
| Radiographic complete response | 10 |
| Lack of radiographic complete response | 10 |
| Completed | 10 |
| Not completed | 10 |
| Withdrew: Radiographic complete response moved to observation rather than maintenance | 10 |
| Milestone | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Started | 10 |
| Discontinued maintenance early | 6 |
| Completed all 8 cycles | 4 |
| Completed | 10 |
| Not completed | 0 |
For each patient, progression-free survival (PFS) is measured from cycle 1 day 1 (C1D1) of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 2-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, participants will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 2 years are reported here.
| percent participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Progression Free Survival (PFS) at 2 Years | 66 (41.6 to 82.2) |
MRD defined as reduction to \>=10\^-6 fold reduction in the IgVH unique clone of mantle cell lymphoma (MCL) by next generation (NGS). MRD status will be evaluated after 2 cycles of induction chemoimmunotherapy with bendamustine and obinutuzumab, after 4 cycles of consolidation with obinutuzumab, and after an additional 8 cycles of maintenance with obinutuzumab. MRD status will be summarized using frequency and proportion with 95% confidence intervals. MRD status will be collected on peripheral blood after cycle 2 of induction therapy, on peripheral blood and bone marrow aspirate after consolidation obinutuzumab, and peripheral blood after maintenance therapy completion.
| Participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| MRD negative (blood) after Induction Phase | 13 |
| MRD negative (blood and marrow) post-Consolidation Phase | 10 |
| MRD negative (blood only) post-Consolidation Phase | 6 |
Concordance between PB and BMA in predicting MRD negative status will be summarized by percent of subjects in which MRD status is concordant (i.e., both positive in the PB and BMA or both negative in the PB and BMA).
| Participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Estimate the Concordance Rate Between Peripheral Blood (PB) and Bone Marrow Aspirates (BMA) in Predicting MRD Status. | 14 |
Lugano criteria will be used to assess radiographic response by CT and/or positron emission tomography (PET) imaging. Imaging for response assessment will be performed after 4 cycles of induction therapy, after consolidation obinutuzumab, and after cycles 4 and 8 of maintenance obinutuzumab. Bone marrow biopsy will be performed verify complete responses. Assessed as the best response over the course of therapy from any of the following time points: at the end of induction cycle 4 (each cycle is 28 days), after consolidation therapy (post-induction, consolidation is 4 weekly doses Obinutuzumab), and after Cycles 4 and 8 of Maintenance Obinutuzumab (each cycle is 8 weeks).
| Participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Complete Response | 15 |
| Partial Response | 4 |
| Overall Objective Response | 19 |
For a given participant, OS will be measured from C1D1 of the induction chemoimmunotherapy to the day the subject dies. Survival times of subjects who are still alive at the end of the follow-up period will be censored. OS will be summarized using point estimate of the median OS, along with the 95% confidence interval.
| percent participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| 2-year Overall Survival | 75.4 (50.6 to 89.0) |
| 3-year Overall Survival | 60.9 (33.9 to 79.7) |
Count of toxicities from the initiation of study treatment until 30 days following the last administration of study treatment or study discontinuation/termination; after this period, only serious adverse events (SAEs) that are possibly, probably, or definitely attributed will be reported. For a given subject, toxicities will be assessed from the time of C1D1 of study therapy until 30 days after completion of final dose of study-related treatment.
| Participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 During Therapy Induction BO Chemoimmunotherapy and Obinutuzumab Consolidation and Maintenance | 21 |
For each patient, progression-free survival (PFS) will be measured from C1D1 of induction chemoimmunotherapy to the day patient experiences an event of disease progression or death, whichever occurs first. If a patient has not experienced an event at the time of analysis, patient's data will be censored at the date of the last available evaluation. The 3-year PFS probability will be estimated using the Kaplan-Meier method. From the date of C1D1 of induction therapy to the date of progression or death; in the absence of progression or death, subjects will be followed for a minimum of 24 months after completion of study-related treatment. PFS rates at 3 years are reported here.
| percent participants | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Progression Free Survival (PFS) at 3 Years | 58.7 (33.2 to 77.3) |
Collected over up to 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bendamustine + Obinutuzumab (BO) | 9/21 (42.9%) | 9/21 (42.9%) | 21/21 (100%) |
| Event | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/21 |
| Atrial fibrillation / flutterBlood and lymphatic system disorders | 2/21 |
| Colitis / Abdominal InfectionGastrointestinal disorders | 2/21 |
| Infusion related reactionGeneral disorders | 2/21 |
| PneumoniaInfections and infestations | 2/21 |
| Myocardial infarctionCardiac disorders | 1/21 |
| Allergic reactionImmune system disorders | 1/21 |
| ThrombocytopeniaInvestigations | 1/21 |
| NeutropeniaInvestigations | 1/21 |
| Genital EdemaReproductive system and breast disorders | 1/21 |
| Event | Bendamustine + Obinutuzumab (BO) |
|---|---|
| NauseaGastrointestinal disorders | 12/21 |
| FatigueGeneral disorders | 11/21 |
| DiarrheaGastrointestinal disorders | 10/21 |
| Neutrophil count decreasedInvestigations | 10/21 |
| White blood cell decreasedInvestigations | 10/21 |
| Lymphocyte count decreasedInvestigations | 9/21 |
| ConstipationGastrointestinal disorders | 7/21 |
| General disorders and administration site conditions - Other, specifyGeneral disorders | 7/21 |
| Platelet count decreasedInvestigations | 6/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/21 |
| Age, Customized(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| 50-59 years | 1 |
| 60-69 years | 8 |
| 70-79 years | 9 |
| 80-89 years | 3 |
| Sex: Female, Male(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Female | 5 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| United States | 21 |
| ECOG Performance Status(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| ECOG Performance Status 0 | 9 |
| ECOG Performance Status 1 | 9 |
| ECOG Performance Status 2 | 3 |
| Stage(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Stage II | 1 |
| Stage III | 0 |
| Stage IV | 20 |
| MIPI Score(Participants) | Bendamustine + Obinutuzumab (BO) |
|---|---|
| Low Risk | 1 |
| Intermediate Risk | 6 |
| High Risk | 14 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Bendamustine · Obinutuzumab
University of Wisconsin, Madison →