Rituximab for Non-Hodgkin's Lymphoma

University of Wisconsin Carbone Cancer Center, Madison, WI
Non-Hodgkin's Lymphoma+1 More ConditionsRituximab - Drug
Eligibility
65+
All Sexes

Study Summary

This trial is testing a new way to give R-CHOP chemotherapy to elderly people with DLBCL. It will last 2.5 years and people may be eligible if they are aged 70-74.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Zanubrutinib
1
Rituximab
1
Oral Azacitidine

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: up to 2 years 6 months

Year 6
Cancer-Specific Geriatric Assessment
Incidence of Treatment Emergent Adverse Events
Overall Survival (OS)
Progression Free Survival (PFS)
up to 6 months
Complete Response Rate (CR)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Zanubrutinib
1
Rituximab
2
Oral Azacitidine

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.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

1 Treatment Group

Split Dose R-CHOP
1 of 1

Experimental Treatment

46 Total Participants · 1 Treatment Group

Primary Treatment: Rituximab · No Placebo Group · Phase 2

Split Dose R-CHOPExperimental Group · 6 Interventions: Rituximab, Vincristine, Pegfilgrastim, Cyclophosphamide, Doxorubicin, Prednisone · Intervention Types: Drug, Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Vincristine
FDA approved
Filgrastim
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years 6 months

Who is running the clinical trial?

Medical College of WisconsinOTHER
577 Previous Clinical Trials
1,156,137 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,102 Previous Clinical Trials
2,900,357 Total Patients Enrolled
Nirav Shah, MD, MSStudy ChairMedical College of Wisconsin Clinical Cancer Center
Christopher Fletcher, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate if you were previously treated for low grade NHL with medications that did not contain anthracycline.
You have lymphoma that has spread to multiple parts of your body or is in an advanced stage.
You are expected to live for at least 3 more months.
References

Frequently Asked Questions

What medical ailment is Rituximab routinely used to treat?

"Rituximab is widely used to treat lung cancers, but can also be prescribed as a treatment for small cell lung cancer (sclc), thyroiditis and polyangium." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies available for participation in this investigation?

"Affirmative. Per clinicaltrials.gov, this medical trial is currently recruiting participants and was first posted on February 16th 2021 with the most recent edit made October 4th 2022. The study requires 46 patients from one site to complete enrollment." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration sanctioned Rituximab as a safe treatment?

"Rituximab, which is being tested in Phase 2 clinical trials, has been evaluated for its safety and received a score of 2. As yet, no data exists to support the efficacy of this drug." - Anonymous Online Contributor

Unverified Answer

What other experimental trials have utilized Rituximab?

"Presently, 1507 studies are underway researching the efficiency of Rituximab. Of these trials, 327 have passed into Phase 3 experimentation. Although most facilities conducting research on this medication are situated in Bethesda, Maryland; there exist 54 042 sites across the globe running clinical experiments with Rituximab." - Anonymous Online Contributor

Unverified Answer

How many participants has this trial recruited thus far?

"Affirmative, the clinical trial is actively searching for participants according to information on clinicaltrials.gov. It was initially posted on February 16th 2021 and most recently updated October 4th 2022. The study requires 46 volunteers from one location." - 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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