Phase 2
N=42
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00244985 ↗Enrolled (actual)
42
Serious AEs
14.3%
Results posted
Jul 2017
Primary outcome: Primary: Complete Response Rate at 20 Weeks — 45 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); pegylated liposomal doxorubicin hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate at 20 Weeks |
45 | — |
| SECONDARY Partial Response Rate at 20 Weeks |
19 | — |
| SECONDARY Overall Response Rate (Complete and Partial Responses) at 20 Weeks |
64 | — |
| SECONDARY Progression Free Survival (PFS) Rate at 2 Years |
42 | — |
| SECONDARY Overall Survival (OS) Rate at 2 Years |
83 | — |
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. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes:
- Grade 1-3 follicular lymphoma
- Mantle cell lymphoma
- Small lymphocytic lymphoma
- Diffuse large B-cell lymphoma
- Diffuse mixed cell lymphoma
- Marginal zone lymphoma
- Relapsed or refractory CD20-positive disease
- Measurable disease
- Must have received ≥ 1 but 7 g/dL
Hepatic
- AST or ALT 400 mg/m^2
- No other concurrent chemotherapy
Endocrine therapy
- Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes) allowed
- No concurrent corticosteroids except for a transient inflammatory reaction (i.e., skin rash or hives)
Radiotherapy
- Recovered from prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery (other than diagnostic surgery) and recovered
Other
- No other concurrent antitumor agents
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00244985). 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.