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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

Study 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.Check my eligibility
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.See study design
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
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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.
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My HIV responds to treatment.
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I am on HIV medication but not taking zidovudine or stavudine.
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I do not have severe numbness or pain in my hands or feet.
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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.
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I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.
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I have never had an AIDS-defining illness.
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I am willing and able to take medication to prevent blood clots.
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My cancer has not spread to my brain or spinal cord.
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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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-year PFS rate of patients treated with RBV to an induction regimen of RB compared to RB alone
PFS improvement of patients treated with lenalidomide added to a consolidation regimen
Secondary outcome measures
PET-documented CR rate
Quality of life
Response rate to RB and RBV
+1 more

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%
Limb injury
3%
Upper respiratory tract infection
3%
Fungal skin infection
3%
Osteoarthritis
3%
Arthralgia
3%
Bronchopneumonia
3%
Musculoskeletal pain
3%
Arthritis
3%
Feeling hot
3%
Productive cough
3%
Larynx irritation
3%
Lipoma
3%
Dry eye
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%
Rheumatoid nodule
2%
Bursitis
2%
Tendonitis
2%
Oedema
2%
Hypertriglyceridaemia
2%
Viral upper respiratory tract infection
2%
Calculus bladder
2%
Spinal compression fracture
2%
Oral herpes
2%
Pyelonephritis acute
2%
Restless legs syndrome
2%
Bowen's disease
2%
Pain
2%
Angioedema
2%
Rotator cuff syndrome
2%
Oedema peripheral
2%
Vulvovaginal mycotic infection
2%
Prostate infection
2%
Cellulitis
2%
Chronic sinusitis
2%
Abdominal wall abscess
2%
Pertussis
2%
Viral infection
2%
Arthropathy
2%
Gastroenteritis viral
2%
Toe deformity
2%
Myalgia
2%
Bone pain
2%
Monarthritis
2%
Chest discomfort
2%
Osteopenia
2%
Synovitis
2%
Cervical root pain
2%
Gastric ulcer
2%
Pharyngeal oedema
2%
Chest injury
2%
Cervicobrachial syndrome
2%
Pharyngeal erythema
2%
Memory impairment
2%
Obesity
2%
Chalazion
2%
Dyspnoea
2%
Stress fracture
2%
Humerus fracture
2%
Tendon rupture
2%
Traumatic haematoma
2%
Wrist fracture
2%
Ankle fracture
2%
Rib fracture
2%
Procedural pain
2%
Eczema nummular
2%
Hyperglycaemia
2%
Anaemia
2%
Keratoconjunctivitis sicca
2%
Visual acuity reduced
2%
Thrombocythaemia
2%
Lymphadenopathy
2%
Iron deficiency anaemia
2%
Hepatomegaly
2%
Cholestasis
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

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
~3920

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
150,457 Total Patients Enrolled
25 Trials studying Lymphoma
7,298 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,780 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,027 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

Bendamustine Hydrochloride (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01415752 — Phase 2
Lymphoma Research Study Groups: Arm C, Arm H, Arm G, Arm A, Arm B, Arm D, Arm E, Arm F
Lymphoma 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

Frequently Asked Questions

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

What clinical indications would necessitate the use of rituximab?

"Rituximab is the preferred medicine for treating diffuse large b-cell lymphoma (dlbcl). It has also been used to ameliorate symptoms related to conditions like prior systemic chemotherapy regimens, polyangium and certain types of B cell lymphomas."

Answered by AI

How many individuals have been recruited for the experimental inquiry?

"Currently, this particular experiment is not enrolling patients. According to the records on clinicaltrials.gov, it was initially posted in May of 2012 and last updated in August of 2020. Nevertheless, there are 1,741 trials actively accepting participants with lymphoma as well as 725 studies for rituximab seeking volunteers at this time."

Answered by AI

Has the Federal Drug Administration approved rituximab?

"Despite being at Phase 2 of clinical trials, there is prior evidence for rituximab's safety which led to it receiving a score of 2."

Answered by AI

How many facilities are presently engaged in this research endeavor?

"In addition to many other sites, Providence Portland Medical Center in Portland, Oregon, Oncology Hematology Care Inc-Mercy West in Cincinnati, Ohio, and Mary Greeley Medical Center in Ames Hawaii are all currently taking part in this clinical trial."

Answered by AI

Does this investigation accept participants above the age of fifty?

"This trial requires that all participants are at least 60 years of age and not above 120."

Answered by AI

Are there any precedents of successful experimentation with rituximab?

"Currently, 725 clinical experiments are in progress to research rituximab with 160 of them being in their terminal stage. Although a portion of these trials is centered around Joliet, Illinois, there are 28017 venues worldwide conducting studies for this drug."

Answered by AI

Are there any remaining vacancies in this research project?

"Per information on clinicaltrials.gov, this research study is not presently recruiting participants even though it was initially posted in May 2012 and last modified on August 10th 2022. Nevertheless, there are 2466 alternate trials that have open recruitment at the time of writing."

Answered by AI

Who is eligible to be included in this exploration?

"Suitable candidates for this lymphoma trial should be aged between 60 and 120 years old. Currently, 373 individuals are required to join the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
2012. "Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01415752.
All > Toxicity > Revlimid
~20 spots leftby Dec 2024
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