All > Mantle Cell Lymphoma

Rituximab for Mantle Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carle Cancer Center NCI Community Oncology Research Program, Urbana, ILMantle Cell Lymphoma+13 MoreRituximab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is studying a combination of drugs to treat mantle cell lymphoma that has come back or does not respond to treatment. The drugs are polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human.

Eligible Conditions
  • Mantle Cell Lymphoma
  • Non-Hodgkin Lymphoma
  • Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Follicular Lymphoma Grade 2 (FL2)
  • Refractory Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma (SLL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Nab-paclitaxel/Rituximab-coated Nanoparticle AR160
1
HDMP + rituximab as a means of debulking prior to initiating venetoclax.
1
CB-010

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Year 5
Best response rate to maintenance therapy
Complete response (CR) rate
Cytokine subset analysis
High risk cytogenetic alterations
Minimal residual disease (MRD) analysis
Overall response rate (ORR)
Risk stratification scores
T cell subset analysis
Year 5
Overall survival (OS)
Year 5
Progression free survival (PFS)
Up to 5 years
Incidence of adverse events (AEs)

Trial Safety

Safety Progress

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

Similar Trials

1
Nab-paclitaxel/Rituximab-coated Nanoparticle AR160
1
HDMP + rituximab as a means of debulking prior to initiating venetoclax.
1
CB-010

Trial Design

1 Treatment Group

Treatment (rituximab, polatuzumab vedotin, venetoclax)
1 of 1

Experimental Treatment

63 Total Participants · 1 Treatment Group

Primary Treatment: Rituximab · No Placebo Group · Phase 2

Treatment (rituximab, polatuzumab vedotin, venetoclax)Experimental Group · 4 Interventions: Polatuzumab Vedotin, Rituximab, Rituximab and Hyaluronidase Human, Venetoclax · Intervention Types: Drug, Biological, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab vedotin
FDA approved
Rituximab
FDA approved
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
50 Previous Clinical Trials
5,186 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,155 Previous Clinical Trials
41,163,486 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorAcademic and Community Cancer Research United
3 Previous Clinical Trials
197 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one visible lump or abnormality that measures at least 1 x 1.5 cm.
You must be able to carry out daily activities without any major issues (ECOG performance status of 0, 1, or 2).
Your blood clotting ability, measured by PTT or aPTT, must not be more than 1.5 times the upper limit of normal.
You have mantle cell lymphoma that has either come back after treatment or did not respond to initial treatment. Tests have shown that your cancer cells have a specific marker called cyclin D1 or a genetic abnormality called t(11;14).
You have a certain type of lymphoma called MCL, follicular lymphoma [FL] [grades I-IIIa], marginal zone lymphoma [MZL], or small lymphocytic lymphoma (SLL) that has come back or gotten worse after trying at least two treatments (or one treatment that contains a specific type of medication called BTK inhibitor). There is no limit to the number of treatments you have tried before. Also, your doctor has determined that your risk of developing tumor lysis syndrome (TLS) is low.
This applies only to the Expansion Portion of the study. You have a type of cancer called MCL that has come back or gotten worse after being treated with at least two different therapies or one specific therapy called a BTK inhibitor. You may have had a stem cell transplant in the past and there is no limit to the number of previous treatments you have had. You may have also received BTK inhibitor therapy before.
You must have enough infection-fighting cells in your blood (ANC >= 1000/mm^3) within 14 days before starting the study.
You must have a minimum number of platelets in your blood, which will be checked within 14 days before starting the trial.
Your blood count needs to show a hemoglobin level of at least 9.0 g/dL within two weeks before enrolling in the trial.
Your blood clotting test, called international normalized ratio, should not be more than 1.5 times the normal limit, unless you are taking anticoagulant medication. The test should have been done within 14 days before registration.
References

Frequently Asked Questions

What is the precedent for Rituximab's efficacy?

"Rituximab is being trialed in 130 Phase 3 clinical trials, 656 studies in total. The medication is being tested at 24017 locations worldwide, with the majority of these sites based in Edmonton, Alberta." - Anonymous Online Contributor

Unverified Answer

How many people are allowed to participate in this test phase of the treatment?

"This clinical trial needs 63 eligible participants. The inclusion criteria for this study are specified on the website. Those who meet these qualifications and live near either Laura and Isaac Perlmutter Cancer Center at NYU Langone in New York, New York or University of Pennsylvania Abramson Cancer Center in Philadelphia, Pennsylvania are encouraged to apply." - Anonymous Online Contributor

Unverified Answer

What is the primary indication for Rituximab?

"Rituximab is an effective treatment for patients suffering from inflammatory breast cancer (IBC), b-cell lymphomas, and polyangiitis." - Anonymous Online Contributor

Unverified Answer

Are there any geographical restrictions to participating in this research?

"There are 7 sites recruiting patients for this study, including the Laura and Isaac Perlmutter Cancer Center at NYU Langone in New York, University of Pennsylvania Abramson Cancer Center in Philadelphia, Mayo Clinic in Rochester in Rochester, as well as other locations." - Anonymous Online Contributor

Unverified Answer

Are people still being recruited to participate in this trial?

"Yes, this is an ongoing study that is currently recruiting patients. The trial was first posted on 4/1/2021 and was most recently edited on 8/25/2022. The study is looking for 63 participants between 7 sites." - Anonymous Online Contributor

Unverified Answer

Has Rituximab been federally sanctioned for medical use?

"Rituximab's safety has been studied to some extent, but there is no data indicating that it is an effective treatment. Consequently, it received a score of 2." - 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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