Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01760226 · ClinicalTrials.gov registry record · Early Phase 1
Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT01760226: Completed Early Phase 1 study, sponsored by Baylor College of Medicine.
NCT01760226 is a Early Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01760226, a Early Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
Primary Outcome
To evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of use in children and young adults with mature B-cell malignancies, including, DLBCL, and PMBCL, as well as in patients with post-transplant lymphoproliferative disorder (PTLD).
Interventions
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Vincristine
- DRUG Methotrexate
- DRUG DA-EPOCH-R for DLBCL, PTLD, AND PMBCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-12 |
| Phase | Early Phase 1 |
What the finished NCT01760226 record still lists
NCT01760226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT01760226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01760226 about?
NCT01760226 is a clinical study titled "Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies". The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effe...
What is the current status of trial NCT01760226?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2013-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01760226?
The interventions under investigation include: Doxorubicin (DRUG), Etoposide (DRUG), Vincristine (DRUG), Methotrexate (DRUG), DA-EPOCH-R for DLBCL, PTLD, AND PMBCL (DRUG).
Who is sponsoring clinical trial NCT01760226?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01760226's enrollment target sits among peer trials
4 1922nd of 2000 higher than 53 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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 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