Phase 2
N=49
Rituximab, Fludarabine, Mitoxantrone, Dexamethasone (R-FND) Plus Zevalin for High-Risk Follicular Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00290511 ↗Enrolled (actual)
49
Serious AEs
69.4%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With Time to Progression (TTP) — 42; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Mitoxantrone (Drug); Rituximab (Drug); Zevalin (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Time to Progression (TTP) |
42; 4 | — |
| SECONDARY Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT) |
37; 1 | — |
| SECONDARY Tolerance and Efficacy of Maintenance Therapy With Rituximab |
38; 3 | — |
| SECONDARY Median Progression Free Survival |
84 | — |
| SECONDARY Progression Free Survival at 10 Years |
49 | — |
| SECONDARY Overall Survival |
143 | — |
| SECONDARY Percentage of Participants With Overall Survival Rate at 10 Years |
69 | — |
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
Eligibility Criteria
Inclusion Criteria
- Patients with high-risk Ann Arbor stage III-IV follicular lymphoma. High-risk is defined by advanced stage (III or IV), plus any 2 of the following features: age 60 or greater; elevated LDH; Hgb 2 mg% or serum creatinine level > 2 mg%, unless the alteration is due to lymphoma.
- Patients with HIV infection should not be registered on this protocol.
- Patients with an antecedent malignancy whose prognosis is poor (< 90% probability of surviving for 5 yrs).
- All patients should have a cardiac ejection fraction of 50% or more by echocardiography or multiple gated acquisition scan (MUGA).
- Patients who will not accept transfusions of blood products or supportive care measures such as antibiotics are not eligible for this study.
- Female patients must not be pregnant or lactating, and men and women of reproductive potential must follow accepted birth control methods.
- Patients who have received prior murine antibody therapy will be excluded.
- Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have + antibodies are not excluded).
Data sourced from ClinicalTrials.gov (NCT00290511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.