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NCT01636388 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma
A Phase 2 study, sponsored by New York Medical College.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01636388: Clinical Trial Phase 2 study, sponsored by New York Medical College.
NCT01636388 is a Phase 2 study that was terminated before completion, run by New York Medical College. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636388, a Phase 2 study, was terminated before completion, sponsored by New York Medical College.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity conditioning regimens predetermined at each institutional center of the Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL infusion for three doses post AlloSCT. The investigators hypothesize that the addition of donor derived LMP specific CTLs will be safe and feasible.
Primary Outcome
The number of serious adverse events associated with administering allogeneic HLA matched donor derived LMP specific-CTLs in CAYA with EBV-associated refractory/relapsed HL following reduced intensity conditioning (RIC) and allogeneic HSCT will be monitored to determine the safety of this treatment.
Interventions
- BIOLOGICAL allogeneic donor derived LMP specific cytotoxic T-lymphocyte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
Why NCT01636388 stopped before completion
NCT01636388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which allogeneic donor derived LMP specific cytotoxic T-lymphocyte is the first listed.
NCT01636388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636388 about?
NCT01636388 is a clinical study titled "Allogeneic Stem Cell Transplantation With Adoptive Immunotherapy in Epstein-Barr Virus Positive Recurrent/Refractory Hodgkins Lymphoma". The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV positive patients with ...
What is the current status of trial NCT01636388?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-01. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01636388?
The interventions under investigation include: allogeneic donor derived LMP specific cytotoxic T-lymphocyte (BIOLOGICAL).
Who is sponsoring clinical trial NCT01636388?
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 NCT01636388's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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