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NCT01145209 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01145209: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01145209 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01145209, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: \- Ofatumumab was approved by the U.S. Food and Drug Administration to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not responded to standard chemotherapy. Ofatumumab is a substance that recognizes specific types of white blood cells called B-lymphocytes, which become cancerous in CLL/SLL. Ofatumumab attaches to a molecule called CD20, which is found on the surface of B-cells, and destroys them. Previous studies have shown that ofatumumab can decrease the number of B-cells in patients with CLL/SLL who have been treated with chemotherapy, but more research is needed to determine it if can also be used to treat patients with previously untreated CLL/SLL. Objectives: \- To determine a safe and effective dose of ofatumumab, along with chemotherapy, to treat chronic lymphocytic leukemia or small lymphocytic lymphoma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with CLL or SLL that has not been treated with chemotherapy. Design: * Eligible participants will be screened with a physical exam, blood samples, lymph node and bone marrow biopsies, and imaging studies. * Participants will be separated into 2 groups: all participants will receive ofatumumab and fludarabine, and some participants will be selected to also receive cyclophosphamide (based on results of certain blood tests). * Participants will receive the study drugs (ofatumumab and fludarabine, and optional cyclophosphamide) by infusion for a maximum of 6 days, followed by 21 days off drug. * Participants will have 6 cycles of treatment according to a schedule set by the study doctors, and may have their dose levels adjusted if side effects develop. * Participants who have disease remaining after 6 cycles will receive additional ofatumumab every 2 months, starting 2 months after the end of the 6th cycle and continuing for a total of 4 doses, before entering the follow-up phase of the trial. Participants who do
Primary Outcome
Death or disease progression defined by the 2008 IWCLL guideline as follows; * Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging * Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which w
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine Phosphate
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-07-01 |
| Est. Completion | 2023-09-15 |
| Phase | Phase 2 |
What the finished NCT01145209 record still lists
NCT01145209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01145209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01145209 about?
NCT01145209 is a clinical study titled "Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL". Background: \- Ofatumumab was approved by the U.S. Food and Drug Administration to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not responded to standard chemotherapy. Ofatumumab is a substance that recognizes specific types of white blood cell...
What is the current status of trial NCT01145209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2010-07-01. Estimated completion is 2023-09-15.
What interventions are being tested in trial NCT01145209?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine Phosphate (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01145209?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01145209's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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