CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
ISF35biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00772486
NCT00772486Phase 1Completed
CompareCT.gov

A Phase 1b Study of Repeated Doses of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35) in Combination With Fludarabine, Cyclophosphamide and Rituximab (FCR) in Subjects With Chronic Lymphocytic Leukemia (CLL)

Memgen, LLC·interventional·Posted Oct 15, 2008·Updated Sep 22, 2021

In Brief

A Phase 1 clinical trial evaluating ISF35 for Chronic Lymphocytic Leukemia. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The study is a Phase 1b open label, non-randomized, single institution clinical trial that is designed to evaluate the safety and tolerability of three repeat infusions of ISF35 followed by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR) in subjects with refractory, resistant, and/or 17p- CLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsThe Leukemia and Lymphoma Society, University of California, San Diego

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2008
Enrollment StartSep 1, 2008
Primary CompletionApr 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.7 years ago

Interventions

ISF35biological

Subjects participating in this study will receive a course of three infusions of 3x10\^8 ISF35-transduced cells at periods of not less than 14 days apart followed by a standard regimen of three cycles of fludarabine, cyclophosphamide and rituximab (FCR) at monthly intervals.