← Back to Search

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 below
Select...
I can take care of myself and perform daily activities.
Select...
My lymphoma is confirmed as mantle cell type with specific genetic markers.
Select...
I have had a blood clot and take medication to prevent another.
Select...
I do not have severe heart problems or uncontrolled chest pain.
Select...
My HIV responds to treatment.
Select...
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.
Select...
I am not in another clinical trial or taking experimental drugs.
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2011 Phase 3 trial • 224 Patients • NCT01126541
20%
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%
Larynx irritation
3%
Arthritis
3%
Osteoarthritis
3%
Limb injury
3%
Dry eye
3%
Musculoskeletal pain
3%
Upper respiratory tract infection
3%
Lipoma
3%
Bronchopneumonia
3%
Feeling hot
3%
Productive cough
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%
Procedural pain
2%
Vulvovaginal mycotic infection
2%
Chest discomfort
2%
Cervical root pain
2%
Pain
2%
Hepatomegaly
2%
Toe deformity
2%
Gastric ulcer
2%
Dyspnoea
2%
Oedema peripheral
2%
Rib fracture
2%
Traumatic haematoma
2%
Prostate infection
2%
Hypertriglyceridaemia
2%
Arthropathy
2%
Tendon rupture
2%
Hyperglycaemia
2%
Synovitis
2%
Calculus bladder
2%
Oedema
2%
Lymphadenopathy
2%
Visual acuity reduced
2%
Chronic sinusitis
2%
Viral upper respiratory tract infection
2%
Oral herpes
2%
Rotator cuff syndrome
2%
Pharyngeal erythema
2%
Eczema nummular
2%
Memory impairment
2%
Angioedema
2%
Pertussis
2%
Chalazion
2%
Bone pain
2%
Abdominal wall abscess
2%
Bursitis
2%
Anaemia
2%
Iron deficiency anaemia
2%
Cholestasis
2%
Pyelonephritis acute
2%
Spinal compression fracture
2%
Restless legs syndrome
2%
Pharyngeal oedema
2%
Chest injury
2%
Gastroenteritis viral
2%
Tendonitis
2%
Keratoconjunctivitis sicca
2%
Myalgia
2%
Ankle fracture
2%
Viral infection
2%
Osteopenia
2%
Humerus fracture
2%
Cellulitis
2%
Cervicobrachial syndrome
2%
Wrist fracture
2%
Thrombocythaemia
2%
Obesity
2%
Bowen's disease
2%
Monarthritis
2%
Rheumatoid nodule
2%
Stress fracture
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
268 Previous Clinical Trials
151,222 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,676 Total Patients Enrolled
Mitchell R. Smith, MD, PhDPrincipal InvestigatorFox Chase Cancer Center
5 Previous Clinical Trials
118 Total Patients Enrolled

Media Library

Bendamustine Hydrochloride (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01415752 — Phase 2
Toxicity Research Study Groups: Arm C, Arm H, Arm G, Arm A, Arm B, Arm D, Arm E, Arm F
Toxicity Clinical Trial 2023: Bendamustine Hydrochloride Highlights & Side Effects. Trial Name: NCT01415752 — Phase 2
Bendamustine Hydrochloride (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01415752 — Phase 2
~3 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top