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Alkylating agents

Bendamustine + Obinutuzumab for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Julie Chang, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new chemotherapy treatment for people with a certain type of cancer.

Who is the study for?
This trial is for adults with untreated Mantle Cell Lymphoma who haven't had cytotoxic chemotherapy but may have had rituximab or radiotherapy. They should have measurable cancer, be ineligible for intensive chemo or stem cell transplant due to health issues, and must not be pregnant or have central nervous system involvement by the lymphoma.Check my eligibility
What is being tested?
The study tests a combination of bendamustine and obinutuzumab as initial treatment (induction), followed by maintenance therapy with obinutuzumab alone. It's an open-label trial where all participants receive the same treatment without a comparison group.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication, low blood counts leading to increased infection risk, fatigue, liver function changes, and potential heart or lung complications related to pre-existing conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) at 2 years
Secondary outcome measures
Determine objective response rates (CR + PR) with induction BO in previously untreated MCL using the Lugano classification for response in lymphoma
Estimate the concordance rate between peripheral blood (PB) and bone marrow aspirates (BMA) in predicting MRD status.
Minimal Residual Disease (MRD) status
+2 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574
44%
Neutropenia
35%
Thrombocytopenia
35%
Diarrhea
29%
Cough
24%
Arthralgia
23%
Infusion related reaction
19%
Fatigue
19%
Back pain
19%
Hypertension
17%
Anaemia
17%
Constipation
17%
Pyrexia
16%
Upper respiratory tract infection
15%
Rash maculo-papular
14%
Muscle spasms
14%
Atrial fibrillation
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Dyspnoea
11%
Vomiting
11%
Pain in extremity
11%
Dizziness
10%
Cataract
10%
Decreased appetite
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Adenocarcinoma of colon
3%
Gastroenteritis
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Malignant melanoma
1%
Haemoptysis
1%
Acute myocardial infarction
1%
Non-small cell lung cancer
1%
Inclusion body myositis
1%
Colorectal cancer
1%
Arthritis
1%
Uterine prolapse
1%
Compartment syndrome
1%
Leukopenia
1%
Bronchitis chronic
1%
Bronchopulmonary aspergillosis
1%
Concussion
1%
Respiratory failure
1%
Oesophageal rupture
1%
Peripheral ischaemia
1%
Colorectal cancer metastatic
1%
Invasive ductal breast carcinoma
1%
Ischaemic stroke
1%
Myelodysplastic syndrome
1%
Pleural effusion
1%
Cardiac failure congestive
1%
Gastritis
1%
Bacterial sepsis
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bendamustine + Obinutuzumab (BO)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,192 Previous Clinical Trials
3,162,006 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,032 Total Patients Enrolled
Julie Chang, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Mantle Cell Lymphoma Research Study Groups: Bendamustine + Obinutuzumab (BO)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still recruiting participants for this experiment?

"That is accurate. As of 9/13/2022, the clinical trial posted on 10/19/2017 was still edited and looking for 32 participants at 1 site."

Answered by AI

What is the existing research on Obinutuzumab?

"173 Obinutuzumab trials are currently active with 36 of those in Phase 3. Most of the Plymouth, Indiana based trials for Obinutuzumab are running out, however there are 9502 locations globally conducting similar research."

Answered by AI

How many subjects are currently enrolled in this research project?

"That is accurate. According to the listing on clinicaltrials.gov, this study is still looking for subjects. This trial was first advertised on October 19th, 2017 and received its last update on September 13th, 2020. The research team needs 32 individuals from 1 location."

Answered by AI

What is the main purpose of Obinutuzumab?

"cancers including refractory mantle cell lymphoma, refractory follicular lymphoma, and chronic lymphocytic leukemia (cll) may be responsive to Obinutuzumab treatment."

Answered by AI

When was Obinutuzumab cleared by the FDA?

"Obinutuzumab falls into the Phase 2 category, meaning that while there is evidence of its safety, there is none yet to support efficacy. Therefore, it was given a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma
2017. "Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03311126.
~3 spots leftby May 2025
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