Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01451515 · ClinicalTrials.gov registry record · Phase 2
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01451515 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 23 participants.
The verdict
NCT01451515, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a phase II clinical trial using risk-adapted therapy. The treatment is acute lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months. Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma. The Primary Objective of this study is: To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal residual disease (MRD)- based risk-adapted therapy. The Secondary Objectives of this study are: * To estimate the event-free survival and overall survival of children with lymphoblastic lymphoma who are treated with MDD- or MRD-based risk- directed therapy. * To evaluate the prognostic value of levels of MDD at diagnosis and MRD on day 8 of remission induction.
Interventions
- DRUG Vincristine
- DRUG Prednisone
- DRUG Daunorubicin
- DRUG Erwinia asparaginase
- DRUG PEG-asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-05-25 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451515
The ClinicalTrials.gov registry entry for NCT01451515 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vincristine is the first listed.
NCT01451515 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01451515 about?
NCT01451515 is a clinical study titled "NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma". This is a phase II clinical trial using risk-adapted therapy. The treatment is acute lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months. Participants will be classified into ...
What is the current status of trial NCT01451515?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-05-25. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT01451515?
The interventions under investigation include: Vincristine (DRUG), Prednisone (DRUG), Daunorubicin (DRUG), Erwinia asparaginase (DRUG), PEG-asparaginase (DRUG).
Who is sponsoring clinical trial NCT01451515?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.