Phase 2
N=24
Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00460109 ↗Enrolled (actual)
24
Serious AEs
30.4%
Results posted
Apr 2017
Primary outcome: Primary: Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) — 0.48 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- denileukin diftitox (Biological); rituximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) |
0.48 | — |
| SECONDARY Survival Time |
NA | — |
| SECONDARY Time to Disease Progression |
NA | — |
| SECONDARY Duration of Response |
22.5 | — |
| SECONDARY Time to Subsequent Therapy |
NA | — |
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
- Stage III or IV disease
- Grade 1 or 2 disease
- Previously untreated disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
- Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR > 2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging
- Splenic enlargement may be used as a measurable parameter if the spleen is palpable ≥ 3 cm below the left costal margin
- Circulating tumor cells < 5,000/mm³
- Must have paraffin-embedded tissue blocks/slides available
- No CNS lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 1 year
- WBC ≥ 3,400/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10.0 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- AST ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Albumin ≥ 3 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after completion of study therapy
- No HIV infection
- No other active malignancies
- No active uncontrolled infection
- No known hypersensitivity to denileukin diftitox or any of its components, including diphtheria toxin, aldesleukin, or excipients
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL
Data sourced from ClinicalTrials.gov (NCT00460109). 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.