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NCT01497496 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01497496: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01497496 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497496, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
The main purpose of this study is to see if the combination of ofatumumab with high dose methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.
Primary Outcome
ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (\>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Interventions
- DRUG Lenalidomide
- DRUG Ofatumumab
- DRUG High Dose Methylprednisolone (HDMP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-01-26 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 2 |
What the finished NCT01497496 record still lists
NCT01497496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.
NCT01497496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497496 about?
NCT01497496 is a clinical study titled "Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)". The main purpose of this study is to see if the combination of ofatumumab with high dose methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with relapsed or refractory CLL/SLL get rid of their CLL/SLL for a long period of time. Researchers also want ...
What is the current status of trial NCT01497496?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2012-01-26. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT01497496?
The interventions under investigation include: Lenalidomide (DRUG), Ofatumumab (DRUG), High Dose Methylprednisolone (HDMP) (DRUG).
Who is sponsoring clinical trial NCT01497496?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01497496's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 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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