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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00290511
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4.
  • Mitoxantrone — DRUG
    10 mg/m\^2 IV over 5-30 minutes on Day 2.
  • Rituximab — DRUG
    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).
  • Zevalin — DRUG
    0.3 mCi/kg IV after 4 cycles of R-FND.
  • Dexamethasone — DRUG
    20 mg by mouth (PO) or IV daily on Days 2-6.

Study Details

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

Key Dates

Start date
Jun 29, 2004
Status verified
Mar 2022
Primary completion
Feb 12, 2021
Completion
Feb 12, 2021

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-FIND + Zevalin
    Fludarabine 25 mg/m\^2 intravenous (IV) over 5-30 minutes on Days 2-4. Mitoxantrone 10 mg/m\^2 IV over 5-30 minutes on Day 2. 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). Zevalin 0.3 mCi/kg IV after 4 cycles of R-FND. Dexamethasone 20 mg by mouth (PO) or IV daily on Days 2-6.

Primary Outcome Measure

Number of Participants With Time to Progression (TTP) [ Time Frame: baseline, 2 and 4 courses, approximately month 8, 9, and 12 months, then restaging every 4 months, then at 2 years every 4-6 months, then yearly until progressive disease or lost to follow up, average of 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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