Rituximab for Non-Hodgkin's Lymphoma

Fred Hutch/University of Washington Cancer Consortium, Seattle, WA
Non-Hodgkin's Lymphoma+8 More ConditionsRituximab - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is testing polatuzumab vedotin, a new treatment for aggressive large B-cell lymphoma, in combination with other drugs.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • ALK-Positive Large B-Cell Lymphoma
  • T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Primary Mediastinal Large B-Cell Lymphoma
  • Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Non-Hodgkin's Lymphoma
  • B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Double Hit Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 30 days after last dose of polatuzumab or first administration of alternate therapy

Up to 18 weeks
The proportion of patients who are unable to complete 6 cycles of therapy for reasons other than disease progression
Day 30
Incidence of adverse events

Trial Safety

Phase-Based Safety

1 of 3

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1
Rituximab
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Side Effects for

Rituximab
8%Mild/moderate allergic reactions
3%Severe allergic reaction
This histogram enumerates side effects from a completed 2016 Phase 2 & 3 trial (NCT03002038) in the Rituximab ARM group. Side effects include: Mild/moderate allergic reactions with 8%, Severe allergic reaction with 3%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

1 Treatment Group

Treatment (polatuzumab vedotin, combination chemotherapy)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Rituximab · No Placebo Group · Phase 1

Treatment (polatuzumab vedotin, combination chemotherapy)Experimental Group · 7 Interventions: Polatuzumab Vedotin, Rituximab, Etoposide, Doxorubicin, Prednisone, Filgrastim, Cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab vedotin
FDA approved
Rituximab
FDA approved
Beta-D-Glucose
Not yet FDA approved
Doxorubicin
FDA approved
Prednisone
FDA approved
Filgrastim
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after last dose of polatuzumab or first administration of alternate therapy

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,636 Previous Clinical Trials
1,579,118 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,513 Previous Clinical Trials
568,226 Total Patients Enrolled
Ryan LynchPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
4 Previous Clinical Trials
69 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How many test subjects are participating in the ongoing clinical trial?

"Confirmed. Evidently, this clinical trial is currently enrolling participants - it was published on October 27th 2020 and last revised on November 22nd 2022. The investigators are recruiting 50 patients from a single medical centre." - Anonymous Online Contributor

Unverified Answer

To what maladies is Rituximab typically prescribed?

"Rituximab is often utilized to treat merkel cell cancer but it has been proven effective for a variety of other medical conditions including ophthalmia, sympathetic, and prostate cancer." - Anonymous Online Contributor

Unverified Answer

Is there still availability for participants in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this trial, which was initially published on October 27th 2020, is actively recruiting individuals for participation. 50 participants need to be enrolled from a single site." - Anonymous Online Contributor

Unverified Answer

What other exploratory investigations have been conducted concerning Rituximab?

"Presently, 1674 investigations are being conducted on Rituximab. Of those trials, 366 have advanced to the Phase 3 stage at this time. Although most studies occur in Bethesda, Maryland, there are 61190 sites administering tests for this medication worldwide." - Anonymous Online Contributor

Unverified Answer

Has Rituximab been granted sanction from the FDA?

"Due to the limited clinical data on Rituximab, its safety rating is only 1. This is a Phase 1 trial after all, so there are no guarantees of efficacy or safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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