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Proteasome Inhibitor

Bortezomib + Gemcitabine for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Leslie Popplewell, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status >= 60%
Life expectancy of greater than 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab to treat patients with B-cell non-Hodgkin lymphoma.

Who is the study for?
This trial is for adults with B-cell Non-Hodgkin lymphoma that's come back or gotten worse. They can have had up to four prior treatments, but none should include bortezomib or gemcitabine. Participants need a certain level of blood cells and organ function, agree to use birth control, and not be pregnant or breastfeeding. Those with serious illnesses, HIV on antiretrovirals, more than four past chemo regimens, recent other treatments, or certain allergies are excluded.Check my eligibility
What is being tested?
The study tests the combination of bortezomib (which blocks enzymes cancer cells need) and gemcitabine hydrochloride (chemotherapy), along with rituximab (a monoclonal antibody targeting cancer cells). It aims to find the best dose and see how well this mix works against relapsed B-cell Non-Hodgkin lymphoma in a phase I/II setting.See study design
What are the potential side effects?
Possible side effects may include nerve damage leading to numbness or pain (neuropathy), low blood cell counts increasing infection risk and bleeding problems, fatigue from anemia, liver issues shown by changes in blood tests, allergic reactions due to drug sensitivity especially for those allergic to boron or mannitol found in bortezomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to perform daily activities without much difficulty or assistance, with a performance level of at least 60%.
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You are expected to live for at least 3 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at Least One Dose Limiting Toxicity (DLT)
Recommended Phase II Dose
Secondary outcome measures
Number of Subject With Complete Response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (bortezomib, gemcitabine hydrochloride, rituximab)Experimental Treatment4 Interventions
Patients receive bortezomib IV, gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rituximab
2000
Completed Phase 3
~2760
bortezomib
2011
Completed Phase 3
~850
gemcitabine hydrochloride
1997
Completed Phase 2
~990

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,419 Total Patients Enrolled
97 Trials studying Lymphoma
6,437 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,613 Total Patients Enrolled
1,376 Trials studying Lymphoma
381,551 Patients Enrolled for Lymphoma
Leslie Popplewell, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Lymphoma
11 Patients Enrolled for Lymphoma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00863369 — Phase 1 & 2
Lymphoma Research Study Groups: Treatment (bortezomib, gemcitabine hydrochloride, rituximab)
Lymphoma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT00863369 — Phase 1 & 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00863369 — Phase 1 & 2

Frequently Asked Questions

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

Could you provide some background information on rituximab testing?

"There are almost one thousand ongoing clinical trials researching rituximab, with 262 of those in the final stage. Rituximab studies are mostly based out of Shanghai but there are over 45000 other locations conducting research for this medication."

Answered by AI

What are some of the primary conditions that rituximab is used to treat?

"The most common treatment for diffuse large b-cell lymphoma (dlbcl) is rituximab. Rituximab can also help patients with small cell lung cancer (sclc), head and neck carcinoma, and cervical cancers manage their condition."

Answered by AI

How many test subjects are participating in this research?

"This specific trial is no longer recruiting patients, as it was last updated on February 28th, 2022. If you are seeking other trials, there are 1810 active lymphoma studies and 992 active rituximab studies that are looking for participants."

Answered by AI

Are researchers still looking for people to participate in this trial?

"This study is not looking for new participants at the moment. It was first posted on 6/29/2005, with the latest update on 2/28/2022. For those searching for similar studies, 1810 clinical trials are actively recruiting patients with lymphoma and 992 trials involving rituximab are also admitting new patients."

Answered by AI
~2 spots leftby Mar 2025