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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
Must not have
Grade 3 or 4 cardiac failure and/or ejection fraction < 50
Presence of hepatitis or hepatitis B virus (HBV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is significantly reduced.
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I have hepatitis or hepatitis B virus infection.
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I have had treatments like chemotherapy for my mantle cell lymphoma.
Select...
My cancer has spread to my brain or spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Progression-Free Survival (PFS)
Secondary study objectives
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
935 Previous Clinical Trials
422,192 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
~2 spots leftby Sep 2025
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