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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

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

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

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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