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NCT01444716 · ClinicalTrials.gov registry record · Phase 2

Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT01444716: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01444716 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01444716, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.

Primary Outcome

Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.

Interventions

  • BIOLOGICAL Ofatumumab

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2011-12-15
Est. Completion 2020-06-11
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01444716 record still lists

NCT01444716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Ofatumumab is the first listed.

NCT01444716 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01444716 about?

NCT01444716 is a clinical study titled "Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia". This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.

What is the current status of trial NCT01444716?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-12-15. Estimated completion is 2020-06-11.

What interventions are being tested in trial NCT01444716?

The interventions under investigation include: Ofatumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01444716?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01444716's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 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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Source: ClinicalTrials.gov NCT01444716, the US trial registry maintained by the National Library of Medicine. NCT01444716 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.