← Back to Search

Platinum-containing compound

Rituximab for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Molly Gallogly, MD PhD

Research Sponsored by Paolo Caimi, MD

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 12 weeks

Awards & highlights

Study Summary

This trial will test if adding venetoclax to RICE is an effective and safe second line treatment for relapsed/refractory DLBCL.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recommended Phase II Dose

Secondary outcome measures

Median Number of cluster of differentiation 34 (CD34+) Cells/kg

Number of Peripheral Blood Stem Cells Collected

Overall Response Rate

+3 more

Other outcome measures

Analysis for Bcl-2

Analysis for Myc

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Trial Design

1Treatment groups

Experimental Treatment

Group I: V+RICEExperimental Treatment5 Interventions

Venetoclax given in combination with R-ICE chemotherapy (rituximab, ifosfamide, carboplatin, and etoposide) Phase I part of this study is a 3 + 3 design, with 3 dose levels, a minimum of 6 participants (maximum of 18) will be required to identify the recommended phase 2 dose (RP2D). Phase II involvs two stages: In stage I, a total of 16 participants will be accrued. If there are 7 or fewer complete responses (CR), the study will be stopped. Otherwise, an additional 30 participants will be accrued in stage II. The maximum number of treatment cycles with V+RICE is three. Participants who achieve complete remission at the interim response assessment after 2 cycles may omit cycle 3 in order to proceed to subsequent consolidation therapy with autologous stem cell transplant (AHSCT). Participants will proceeed to other treatment including RICE, other chemotherapy, peripheral blood stemm cell collection, and ASCT per institutional guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Carboplatin

2014

Completed Phase 3

~6670

Rituximab

1999

Completed Phase 4

~1880

Etoposide

2010

Completed Phase 3

~2440

Ifosfamide

2010

Completed Phase 4

~2980

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Paolo Caimi, MDLead Sponsor

2 Previous Clinical Trials

47 Total Patients Enrolled

Molly GalloglyLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Molly Gallogly, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Frequently Asked Questions

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

Are there any vacancies in this experiment for new guinea pigs?

"This study is no longer recruiting patients. The listing was created on June 26th, 2017 and last updated on November 14th, 2020. If you are looking for other trials, there are 1820 lymphoma studies and 1498 Rituximab clinical trials that are still searching for participants."

Answered by AI

Rituximab is most often used to treat which type of illness?

"Rituximab is most commonly used as an initial treatment, however it has also been shown to be effective against prostate cancer, small cell lung cancer (sclc), and advanced testicular cancer."

Answered by AI

Could you provide some context for Rituximab's efficacy by discussing other clinical trials that have included it?

"Rituximab was first studied in 1993 and, to date, there have been 1996 completed trials surrounding the medication. Currently, 1498 clinical trials are still active. A large number of these studies are based out of Saint Louis, Missouri."

Answered by AI

How many people can join this clinical trial at the most?

"This clinical trial is not currently recruiting patients. The study was first posted on June 26, 2017 and last updated on November 14, 2022. There are presently 1820 trials actively enrolling patients with lymphoma and 1498 active trials for Rituximab seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Molly Gallogly 2017. "Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03064867.