CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Ofatumumab + Fresh Frozen Plasmadrug
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/NCT01716208
NCT01716208Phase 2Completed

Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Joseph Tuscano·interventional·Posted Oct 29, 2012·Updated May 11, 2021

In Brief

A Phase 2 clinical trial evaluating Ofatumumab + Fresh Frozen Plasma for Chronic Lymphocytic Leukemia. Completed, enrolled 12 participants across 1 site.

Detailed Summary

It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have low levels of complement. Several drugs have been approved by the Food and Drug Administration (FDA) for use in this cancer. However, these drugs are often used as combination therapies which means two or more drugs are part of the treatment. Many people, especially elderly patients, cannot put up with the use of multiple drugs because of the side effects. The main purpose of this study is to see if patients respond to therapy with human plasma (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find out if this therapy will increase chances of getting rid of leukemia. This study will also look at the levels of complement in your blood. The levels of complement may allow better understanding of whether increasing the levels of complement by giving FFP may help control leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2012
Enrollment StartJan 14, 2013
Primary CompletionOct 1, 2019
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 13.7 years ago

Interventions

Ofatumumab + Fresh Frozen Plasmadrug