Phase 2
Completed N=40
High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
B-cell Lymphoma · Indolent B-cell Lymphoma
Source: ClinicalTrials.gov NCT00895661 ↗
Enrolled (actual)
40
Serious AEs
10.0%
Results posted
May 2017
Primary outcomePrimary: Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas — 21 Participants
Summary
The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may offer superior efficacy to the current standard dose. This trial also employs intermittent maintenance doses of rituximab at the standard dose, which has been shown to prolong remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly good results to chemotherapy approaches, but without chemotherapy-related toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas |
21 | — |
| SECONDARY Overall Response Rate (ORR) |
32 | — |
| SECONDARY Progression-free Survival (PFS) |
19 | — |
| SECONDARY Incidence of Severity of Infusion Reactions, Infections and Neutropenia |
3; 19; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Indolent B-Cell NHL of the following histologies:
- Follicular lymphoma (grades 1-3A);
- marginal zone lymphoma (extranodal, nodal or splenic):
- Extranodal marginal zone lymphomas (MALT lymphomas) may not be candidates for cure with antibiotics or local radiotherapy. Patients who have failed antibiotics or local therapy are eligible for the protocol as long as they have measurable disease and are naive to chemotherapy and monoclonal antibody;
- splenic marginal zone lymphoma patients may have received prior splenectomy as long as they have measureable disease and are naive to chemotherapy and monoclonal antibody therapy;
- Small lymphocytic lymphoma (must have less than 5000 circulating clonal B-lymphocytes);
- Indolent CD20+ B-cell lymphoma not otherwise specified with CD20+ expression
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan
- No previous chemotherapy, antibody therapy or radioimmunotherapy for NHL. Patients previously treated with external bean radiation alone, surgery, or with antibiotics are eligible
- 18 years of age or older
- Life expectancy of greater than 3 months
- ECOG performance status of 2 or less
- Adequate bone marrow function
- Use of adequate contraception
Exclusion Criteria
- Prior chemotherapy, monoclonal antibody therapy or radioimmunotherapy for lymphoma
- Receiving any other investigational agent
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab
- HIV positivity
- Active hepatitis B infection
- Candidate for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient
- NYHA Classification III or IV disease
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection that is not optimally treated with antibiotics, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women
- Individuals with a history of a different malignancy except for the following circumstances:
- disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy;
- localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ; and
- non-melanoma skin cancers
Data sourced from ClinicalTrials.gov (NCT00895661). 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. Informational only — not medical advice.