CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
rituximab +1 morebiological
Likely dose
Rituximab IV and pegylated liposomal doxorubicin IV (specific doses not stated in protocol excerpt)AI-extracted
Key inclusion· 9
  • Diagnosis of indolent or aggressive B-cell NHL (follicular grades 1-3, mantle cell, small lymphocytic, diffuse large B-cell, diffuse mixed, or marginal zone)
  • Relapsed or refractory CD20-positive disease
  • Measurable disease
  • Prior receipt of 1-3 standard chemotherapy regimens
Key exclusion· 7
  • Burkitt lymphoma or precursor B-lymphoblastic lymphoma
  • CNS lymphoma
  • History of New York Heart Association class II-IV cardiac disease or congestive heart failure
  • Prior cumulative doxorubicin (or equivalent anthracycline) dose >400 mg/m²

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00244985
NCT00244985Phase 2Completed

A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma

Roswell Park Cancer Institute·interventional·Posted Oct 27, 2005·Updated Aug 17, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab and pegylated liposomal doxorubicin hydrochloride for Lymphoma. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsOrtho Biotech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2005
Enrollment StartSep 1, 2005
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.7 years ago

Interventions

rituximabbiological

IV

pegylated liposomal doxorubicin hydrochloridedrug

IV