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NCT01453205 · ClinicalTrials.gov registry record · Phase 2
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 2 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT01453205: Completed Phase 2 study, sponsored by MedImmune.
NCT01453205 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453205, a Phase 2 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study Summary
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
Primary Outcome
Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (\>=) 50% decrease in SPD of spleen/liver nodules.
Interventions
- DRUG Rituximab
- PROCEDURE Autologous Stem Cell Transplant (ASCT)
- DRUG ICE
- DRUG DHAP
- DRUG MEDI-551 2 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2016-07-11 |
| Phase | Phase 2 |
What the finished NCT01453205 record still lists
NCT01453205 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT01453205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01453205 about?
NCT01453205 is a clinical study titled "A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)". The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has s...
What is the current status of trial NCT01453205?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2012-02-27. Estimated completion is 2016-07-11.
What interventions are being tested in trial NCT01453205?
The interventions under investigation include: Rituximab (DRUG), Autologous Stem Cell Transplant (ASCT) (PROCEDURE), ICE (DRUG), DHAP (DRUG), MEDI-551 2 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01453205?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01453205's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 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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