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NCT01716208 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
A Phase 2 study, sponsored by Joseph Tuscano.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01716208: Completed Phase 2 study, sponsored by Joseph Tuscano.
NCT01716208 is a Phase 2 study that has completed, run by Joseph Tuscano. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01716208, a Phase 2 study, has completed, sponsored by Joseph Tuscano.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
Interventions
- DRUG Ofatumumab + Fresh Frozen Plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-01-14 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 2 |
What the finished NCT01716208 record still lists
NCT01716208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Ofatumumab + Fresh Frozen Plasma is the first listed.
NCT01716208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01716208 about?
NCT01716208 is a clinical study titled "Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma". 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 mo...
What is the current status of trial NCT01716208?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-01-14. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT01716208?
The interventions under investigation include: Ofatumumab + Fresh Frozen Plasma (DRUG).
Who is sponsoring clinical trial NCT01716208?
This trial is sponsored by Joseph Tuscano, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01716208's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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