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Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma

NCT00290511 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-04-22

Study results available
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Summary

The goal of this clinical research study is to learn if chemotherapy given with rituximab, followed by Ibritumomab tiuxetan (Zevalin), and then followed by rituximab can help to control lymphoma. The safety of this treatment schedule will also be studied.

Objectives:

1. To assess whether the time to progression for these high-risk patients can be prolonged to a median of 36 months, compared to the historical expectation of approximately 24 months.
2. To assess the tolerance and efficacy of Y2B8 (Zevalin) after R-FND (rituximab, fludarabine, mitoxantrone, dexamethasone) in patients with high-risk stage III-IV follicular lymphoma
3. To assess overall response, failure-free survival, and survival of this strategy compared to our historical experience with FND (fludarabine, mitoxantrone, dexamethasone) alone or R-FND
4. To assess the tolerance and efficacy of maintenance therapy with rituximab.
5. To maximize the 12-month molecular remission rate for patients with high-risk stage III-IV follicular lymphoma
6. to correlate the results of quantitative PCR assay with classical PCR and with clinical outcome

Conditions

Interventions

DRUG

Fludarabine

25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4.

DRUG

Mitoxantrone

10 mg/m\^2 IV over 5-30 minutes on Day 2.

DRUG

Rituximab

375 mg/m\^2 IV over 4-6 hours on Day 1 and 8; maintenance Rituximab = 375 mg/m\^2 IV over 4-6 hours on Day 1 only, a single dose every other month for 12 months (6 doses total).

DRUG

Zevalin

0.3 mCi/kg IV after 4 cycles of R-FND.

DRUG

Dexamethasone

20 mg by mouth (PO) or IV daily on Days 2-6.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Biogen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nathan Fowler, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-29
Primary Completion
2021-02-12
Completion
2021-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290511 on ClinicalTrials.gov