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Alkylating agents
Combination Therapy for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Mitchell R. Smith, MD, PhD
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-2
Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of rituximab, bortezomib, bendamustine, and lenalidomide to see how well it works compared with rituximab and bendamustine, followed by rituximab alone or with lenalidomide, in treating mantle cell lymphoma.
Who is the study for?
This trial is for older adults with untreated Mantle Cell Lymphoma (MCL). Participants must have proper liver function, no central nervous system involvement, and not be pregnant. HIV-positive patients can join if they meet specific health criteria. Contraception use is required, and there should be no history of severe allergies to the drugs used or conditions that could affect study participation.
What is being tested?
The trial tests a combination of rituximab with bendamustine hydrochloride and bortezomib versus rituximab with lenalidomide in treating MCL. It aims to discover which drug combo is more effective at stopping cancer growth by either killing cancer cells directly or cutting off their blood supply.
What are the potential side effects?
Possible side effects include allergic reactions to monoclonal antibodies like rituximab, chemotherapy-related issues from bendamustine such as nausea and low blood counts, nerve damage from bortezomib, and risks of blood clots when taking lenalidomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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My lymphoma is confirmed as mantle cell type with specific genetic markers.
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I have had a blood clot and take medication to prevent another.
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I do not have severe heart problems or uncontrolled chest pain.
Select...
My HIV responds to treatment.
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I am on HIV medication but not taking zidovudine or stavudine.
Select...
I do not have severe numbness or pain in my hands or feet.
Select...
I am not allergic to bortezomib, boron, or mannitol.
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I am not in another clinical trial or taking experimental drugs.
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My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.
Select...
I have never had an AIDS-defining illness.
Select...
I am willing and able to take medication to prevent blood clots.
Select...
My cancer has not spread to my brain or spinal cord.
Select...
My lymphoma is only in my liver and can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2011 Phase 3 trial • 224 Patients • NCT0112654120%
Bronchitis
17%
Asthenia
17%
Cough
15%
Back pain
14%
Urinary tract infection
12%
Gastroenteritis
12%
Rheumatoid arthritis
11%
Nausea
11%
Headache
11%
Nasopharyngitis
11%
Hypercholesterolaemia
8%
Abdominal pain upper
8%
Conjunctivitis
8%
Vertigo
6%
Vomiting
6%
Pharyngitis
6%
Tonsillitis
6%
Sinusitis
6%
Hypertension
6%
Rash
5%
Hot flush
5%
Abdominal pain
5%
Pyrexia
5%
Dysphagia
5%
Rhinitis
5%
Influenza
5%
Sciatica
5%
Rhinitis allergic
3%
Arthralgia
3%
Productive cough
3%
Larynx irritation
3%
Limb injury
3%
Dry eye
3%
Feeling hot
3%
Musculoskeletal pain
3%
Bronchopneumonia
3%
Upper respiratory tract infection
3%
Osteoarthritis
3%
Arthritis
3%
Lipoma
3%
Fungal skin infection
3%
Gingivitis
3%
Tracheitis
3%
Fungal infection
3%
Diarrhoea
3%
Depression
3%
Sleep disorder
3%
Constipation
3%
Neck pain
3%
Chronic obstructive pulmonary disease
3%
Erythema
3%
Eczema
3%
Urticaria
3%
Night sweats
3%
Transaminases increased
3%
Weight increased
2%
Tendon rupture
2%
Cervical root pain
2%
Pain
2%
Hepatomegaly
2%
Monarthritis
2%
Rheumatoid nodule
2%
Pyelonephritis acute
2%
Viral upper respiratory tract infection
2%
Chest discomfort
2%
Stress fracture
2%
Vulvovaginal mycotic infection
2%
Toe deformity
2%
Osteopenia
2%
Viral infection
2%
Anaemia
2%
Rib fracture
2%
Prostate infection
2%
Hypertriglyceridaemia
2%
Memory impairment
2%
Arthropathy
2%
Hyperglycaemia
2%
Synovitis
2%
Calculus bladder
2%
Chronic sinusitis
2%
Oedema peripheral
2%
Oedema
2%
Lymphadenopathy
2%
Visual acuity reduced
2%
Gastric ulcer
2%
Oral herpes
2%
Eczema nummular
2%
Angioedema
2%
Pertussis
2%
Rotator cuff syndrome
2%
Pharyngeal erythema
2%
Chalazion
2%
Humerus fracture
2%
Bursitis
2%
Thrombocythaemia
2%
Abdominal wall abscess
2%
Iron deficiency anaemia
2%
Cholestasis
2%
Dyspnoea
2%
Wrist fracture
2%
Chest injury
2%
Gastroenteritis viral
2%
Tendonitis
2%
Keratoconjunctivitis sicca
2%
Myalgia
2%
Ankle fracture
2%
Cellulitis
2%
Bone pain
2%
Pharyngeal oedema
2%
Obesity
2%
Cervicobrachial syndrome
2%
Spinal compression fracture
2%
Restless legs syndrome
2%
Traumatic haematoma
2%
Bowen's disease
2%
Procedural pain
2%
Onychomycosis
2%
Fatigue
2%
Blood lactate dehydrogenase increased
2%
Blood phosphorus decreased
2%
Ocular hypertension
2%
Retinopathy hypertensive
2%
Urinary retention
2%
Acute sinusitis
2%
Escherichia urinary tract infection
2%
Gastrointestinal disorder
2%
Aphthous stomatitis
2%
Toothache
2%
Venous insufficiency
2%
Anxiety
2%
Breast cancer
2%
Uterine leiomyoma
2%
Vasculitis
2%
Intervertebral disc disorder
2%
Blood thyroid stimulating hormone decreased
2%
Uveitis
2%
Cataract
2%
Bursitis infective
2%
Perianal abscess
2%
Hypertensive crisis
2%
Goitre
2%
Sinobronchitis
2%
Ear infection
2%
Otitis externa
2%
Hypokalaemia
2%
Osteoporosis
2%
Paraesthesia
2%
Throat irritation
2%
Pharyngolaryngeal pain
2%
Asthma
2%
Dysphonia
2%
Dyspnoea exertional
2%
Sleep apnoea syndrome
2%
Epistaxis
2%
Pruritus
2%
Alopecia
2%
Hyperhidrosis
2%
Photosensitivity reaction
2%
Skin exfoliation
2%
Joint injury
2%
Animal bite
2%
Foot fracture
2%
Diabetes mellitus
2%
Phlebitis
2%
Eosinophil count increased
2%
Ventricular extrasystoles
2%
Bundle branch block left
2%
Palpitations
2%
Deoxyribonucleic acid (DNA) antibody positive
2%
Electrocardiogram repolarisation abnormality
2%
Lymphocyte count decreased
2%
Neutrophil count increased
2%
Eye irritation
2%
Lymphopenia
2%
Neutropenia
2%
Tinnitus
2%
Vertigo positional
2%
Basosquamous carcinoma
2%
Renal colic
2%
Renal impairment
2%
Cataract operation
2%
Skin neoplasm excision
2%
Allergy to chemicals
2%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Retreatment Arm A: Rituximab 1000 mg
Nonrandomized: Rituximab 1000 mg
Randomized Retreatment Arm B: Rituximab 1000 mg x 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Arm HExperimental Treatment2 Interventions
Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm GExperimental Treatment2 Interventions
Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group III: Arm FExperimental Treatment1 Intervention
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group IV: Arm EExperimental Treatment1 Intervention
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group V: Arm DExperimental Treatment4 Interventions
Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm H.
Group VI: Arm CExperimental Treatment3 Interventions
Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm G.
Group VII: Arm BExperimental Treatment3 Interventions
Patients receive induction therapy comprising bortezomib IV subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm F.
Group VIII: Arm AExperimental Treatment2 Interventions
Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm E.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bendamustine hydrochloride
2010
Completed Phase 2
~370
rituximab
2000
Completed Phase 3
~2760
bortezomib
2011
Completed Phase 3
~850
lenalidomide
2012
Completed Phase 3
~3370
Find a Location
Who is running the clinical trial?
Eastern Cooperative Oncology GroupLead Sponsor
269 Previous Clinical Trials
151,516 Total Patients Enrolled
26 Trials studying Lymphoma
7,592 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,714 Total Patients Enrolled
1,410 Trials studying Lymphoma
383,395 Patients Enrolled for Lymphoma
Mitchell R. Smith, MD, PhDPrincipal InvestigatorFox Chase Cancer Center
5 Previous Clinical Trials
118 Total Patients Enrolled
4 Trials studying Lymphoma
97 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.People with HIV can participate if they meet specific requirements.My lymphoma is confirmed as mantle cell type with specific genetic markers.I have had a blood clot and take medication to prevent another.I do not have severe heart problems or uncontrolled chest pain.My HIV responds to treatment.I do not have severe numbness or pain in my hands or feet.I have no cancer history except for certain skin cancers, cervical cancer in situ, or any cancer cured over 5 years ago.I am willing to take antiretroviral therapy if needed.I am on HIV medication but not taking zidovudine or stavudine.I am not allergic to bortezomib, boron, or mannitol.I am not in another clinical trial or taking experimental drugs.I agree to take medicine to prevent a specific type of pneumonia during and after my treatment.Your CD4 cell count was less than 300 cells/mm³ when you were diagnosed with lymphoma.My kidneys are functioning well enough, with a creatinine clearance rate of at least 30 mL/min.I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.I have never had an AIDS-defining illness.Your bilirubin levels in the blood are not more than twice the normal limit.You need to have a negative pregnancy test.I do not have a serious illness or mental health condition that could affect my study participation.I am on Arms G or H, have no history of blood clots, and take daily aspirin for clot prevention.Your white blood cell count is at least 1,500 per microliter, unless it's caused by a specific type of bone marrow issue.I cannot take aspirin and am on a blood thinner like heparin or warfarin.I am willing and able to take medication to prevent blood clots.Patients must have at least one specific sign of their disease that can be measured.My cancer has not spread to my brain or spinal cord.Your platelet count should be at least 100,000 per microliter, unless there is a problem with your bone marrow.Your liver enzymes (AST/ALT) are not more than double the normal level.I have no cancer history except for certain skin cancers, cervical cancer in situ, or any cancer cured over 5 years ago.I have not had treatment for MCL, except for a short steroid course.My disease was confirmed by CT scan or similar, not just a PET scan.My lymphoma is only in my liver and can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm H
- Group 3: Arm G
- Group 4: Arm A
- Group 5: Arm B
- Group 6: Arm D
- Group 7: Arm E
- Group 8: Arm F
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.