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NCT01859819 · ClinicalTrials.gov registry record · Phase 2
Treatment for Advanced B-Cell Lymphoma
A Phase 2 study, sponsored by New York Medical College.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01859819: Completed Phase 2 study, sponsored by New York Medical College.
NCT01859819 is a Phase 2 study that has completed, run by New York Medical College. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859819, a Phase 2 study, has completed, sponsored by New York Medical College.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, \[Depocyt®\]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy).
Primary Outcome
To determine if the addition of intrathecal (\[IT\] \[Depocyt®\]) and reduction of standard IT dosing and the reduction of anthracycline exposure (doxorubicin) (60%) within the ANHL01P1 FAB/LMB B4 + Rituximab chemoimmunotherapy backbone in children, adolescents and young adults with good risk CD20+ mature B-NHL (Stage I and II unresected and Stage III/IV with LDH \< 2 UNL) will result in similar response rates compared to historical controls (Subgroup I).
Interventions
- DRUG Rituximab
- DRUG IT Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-01 |
| Est. Completion | 2021-06 |
| Phase | Phase 2 |
What the finished NCT01859819 record still lists
NCT01859819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01859819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01859819 about?
NCT01859819 is a clinical study titled "Treatment for Advanced B-Cell Lymphoma". To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, \[Depocyt®\]) and reducing the dose of anthracycline (doxorubicin) in good risk patients w...
What is the current status of trial NCT01859819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2013-01. Estimated completion is 2021-06.
What interventions are being tested in trial NCT01859819?
The interventions under investigation include: Rituximab (DRUG), IT Cytarabine (DRUG).
Who is sponsoring clinical trial NCT01859819?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01859819's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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