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Anti-tumor antibiotic, Anti-metabolites, Alkylating agents, Topoisomerase II inhibitors, Vinca alkaloids

Rituximab + Chemotherapy for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Izidore S. Lossos, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated, histologically confirmed mantle cell lymphoma
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

Study Summary

This trial is testing if a combination of drugs, including Rituximab, will be more effective than current treatments for Mantle Cell Lymphoma.

Who is the study for?
This trial is for adults over 18 with previously untreated Mantle Cell Lymphoma. Participants must have measurable disease, proper liver and kidney function, not be pregnant or breastfeeding, agree to use birth control, and have a life expectancy of more than 6 months. Those with severe heart issues, other active cancers (except certain skin/cervix cancers), HIV/AIDS, hepatitis infection or CNS involvement cannot join.Check my eligibility
What is being tested?
The study tests Rituximab combined with chemotherapy drugs (Cyclophosphamide, Cytarabine, Doxorubicin etc.), followed by maintenance therapy with Rituximab alone. The goal is to see if this regimen improves response rates and overall survival in patients who haven't been treated for MCL before.See study design
What are the potential side effects?
Possible side effects include reactions to infusions like fever and chills; blood disorders such as anemia; infections due to low white blood cell counts; nausea/vomiting from chemotherapy; hair loss; fatigue; organ damage risks especially the heart and kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mantle cell lymphoma and have not received any treatment for it.
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I am older than 18 years.
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My liver and kidney functions are within the required ranges.
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I can take care of myself and am up and about more than half of my waking hours.
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I have a tumor larger than 1.5 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Progression-Free Survival (PFS)
Secondary outcome measures
Rate of Overall Survival (OS)
Rate of Response to Protocol Therapy
Rate of Treatment-Related Toxicity in Study Participants

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: R-MACLO/IVAMExperimental Treatment11 Interventions
Four 21-day cycles, followed by Maintenance Therapy as follows: Cycles 1 and 3: Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Methotrexate, Leucovorin, and G-CSF per study protocol. Cycles 2 and 4: Rituximab, Cytarabine, Ifosfamide, Mesna, Etoposide, and G-CSF per study protocol. Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years, per study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Rituximab
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Doxorubicin
FDA approved
Etoposide
FDA approved
Ifosfamide
FDA approved
Leucovorin
FDA approved
Coenzyme M
FDA approved
Methotrexate
FDA approved
Vincristine
FDA approved

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,235 Total Patients Enrolled
Izidore S. Lossos, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

Combination Chemotherapy (Anti-tumor antibiotic, Anti-metabolites, Alkylating agents, Topoisomerase II inhibitors, Vinca alkaloids) Clinical Trial Eligibility Overview. Trial Name: NCT00878254 — Phase 2
Mantle Cell Lymphoma Research Study Groups: R-MACLO/IVAM
Mantle Cell Lymphoma Clinical Trial 2023: Combination Chemotherapy Highlights & Side Effects. Trial Name: NCT00878254 — Phase 2
Combination Chemotherapy (Anti-tumor antibiotic, Anti-metabolites, Alkylating agents, Topoisomerase II inhibitors, Vinca alkaloids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00878254 — Phase 2

Frequently Asked Questions

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

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

"Rituximab can be used to fight three types of cancer: lung cancers, small cell lung cancer (sclc), and polyangium."

Answered by AI

Can you give some examples of other times Rituximab has been used in medical research?

"Presently, 442 Rituximab trials are in Phase 3 and 1952 studies are ongoing. Most of these research projects are situated in Bethesda, Maryland; however, there are a total of 68731 clinical trial sites for this medication."

Answered by AI

Are we currently recruiting participants for this research?

"No, this particular study is not looking for new participants. However, there are over 3000 other clinical trials that might be a match for patients seeking to enroll in medical research."

Answered by AI

How many people will be given the opportunity to participate in this test program?

"This study is not recruiting at the moment. It was originally posted on 3/25/2009 and updated for the last time on 8/17/2022. However, there are currently 1762 clinical trials actively enrolling patients with mantle cell lymphoma (mcl) and 1952 trials for Rituximab admitting patients right now."

Answered by AI

Can you quantify the risks associated with Rituximab?

"Rituximab's safety is unproven but there is some data supporting its use, so it received a score of 2."

Answered by AI
~1 spots leftby Sep 2024