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Proteasome Inhibitor
Bortezomib for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Wyndham H Wilson, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 9.9 years
Awards & highlights
Study Summary
This trial will evaluate a new combination chemotherapy regimen for mantle cell lymphoma, a cancer of white blood cells. The regimen includes the drugs prednisone, etoposide, doxorubicin, vincristine, and rituximab, with the addition of bortezomib. The trial will test whether adding bortezomib as "maintenance therapy" once chemotherapy is finished will lengthen the time before the disease relapses and improve the overall cure rate.
Eligible Conditions
- Mantle Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9.9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9.9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median Overall Survival (OS)
Overall Progression Free Survival
Overall Survival
+1 moreSecondary outcome measures
Clinical Response
Count of Participants With Serious and Non-Serious Adverse Events
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: ObservationExperimental Treatment1 Intervention
At the beginning of part C patients are randomized to receive bortezomib maintenance or observation without bortezomib.
Group II: EPOCH-R + BortezomibExperimental Treatment3 Interventions
Combo chemo etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-Rituxan (R) + Bortezomib (B)
Group III: Bortezomib "window"Experimental Treatment1 Intervention
Bortezomib alone
Group IV: Bortezomib maintenanceActive Control1 Intervention
Bortezomib maintenance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Bortezomib D-mannitol
FDA approved
Bortezomib D-mannitol
FDA approved
Bortezomib D-mannitol
FDA approved
EPOCH
2003
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,828 Total Patients Enrolled
Wyndham H Wilson, M.D.Principal InvestigatorNational Cancer Institute (NCI)
7 Previous Clinical Trials
275 Total Patients Enrolled
Frequently Asked Questions
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