Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01078922 · ClinicalTrials.gov registry record · Phase 2
Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas
A Phase 2 study, sponsored by Oncology Specialists, S.C..
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01078922: Clinical Trial Phase 2 study, sponsored by Oncology Specialists, S.C..
NCT01078922 is a Phase 2 study that was terminated before completion, run by Oncology Specialists, S.C.. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078922, a Phase 2 study, was terminated before completion, sponsored by Oncology Specialists, S.C..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a phase II open label study that looks at the efficacy and toxicity of Ofatumumab monotherapy in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Patients will receive weekly infusions of Ofatumumab of 1000 mg each for 8 weeks (induction phase) followed by continuing the study drugs every other week in subsequent cycles (maintenance phase). Each 4 weeks of therapy will be calculated as one cycle. Treatment will continue until disease progression, toxicity, patient's withdrawal, or investigator's discretion.
Primary Outcome
OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients. A CR is defined as: 1. Disappearance of all disease. 2. If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative 3. If the nodal masses were Variably or PET negative; they must regress to normal. 4. No palpable liver or spleen 5. Palpable nodal masses are no longer palpable 6. Negative bone marrow bio
Interventions
- DRUG Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
Why NCT01078922 stopped before completion
NCT01078922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Ofatumumab is the first listed.
NCT01078922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078922 about?
NCT01078922 is a clinical study titled "Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas". This is a phase II open label study that looks at the efficacy and toxicity of Ofatumumab monotherapy in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Patients will receive weekly infusions of Ofatumumab of 1000 mg each for 8 weeks (induction phase) followed by cont...
What is the current status of trial NCT01078922?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2010-02. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01078922?
The interventions under investigation include: Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01078922?
This trial is sponsored by Oncology Specialists, S.C., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078922's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia