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Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

NCT00183989•University of Southern California

View on ClinicalTrials.gov

Summary

This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma. The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
•Newly diagnosed and patients who have received prior treatment are eligible
•Measurable or evaluable disease
•Karnofsky performance status greater or equal to 50%
•Men and women, age greater or equal to 18 years old
•AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
•Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
•Women of child bearing potential must have negative pregnancy test within 14 days of study entry.
•Signed informed consent

Exclusion Criteria

•History of congestive heart failure or significant cardiac disease
•Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab allowed
•Active infection
•HIV seropositive
•Pregnant or lactating females
•Second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
•Presence of psychological or emotional disorders which would make valid informed consent impossible

Locations (1)

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

August 1, 2000

Primary Completion Date

December 1, 2006

Completion Date

December 1, 2006

Last Updated

May 22, 2014

Enrollment

ESTIMATED participants

Conditions

Mantle Cell Lymphoma

Interventions

Fludarabine, Mitoxantrone and Rituximab

DRUG

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)