Rituximab + Chemotherapy for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByIzidore Lossos, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).

Eligibility Criteria

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.

Inclusion Criteria

I have mantle cell lymphoma and have not received any treatment for it.

I am older than 18 years.

My liver and kidney functions are within the required ranges.

I can take care of myself and am up and about more than half of my waking hours.

I have a tumor larger than 1.5 cm.

Exclusion Criteria

My heart's pumping ability is significantly reduced.

I have hepatitis or hepatitis B virus infection.

I have had treatments like chemotherapy for my mantle cell lymphoma.

My cancer has spread to my brain or spinal cord.

Participant Groups

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.

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.