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NCT03033914 · ClinicalTrials.gov registry record · Phase 1
A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)
A Phase 1 study of Hodgkin Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
- 10
- Study locations
NCT03033914: Active Phase 1 study of Hodgkin Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03033914 is a Phase 1 study of Hodgkin Lymphoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 82 participants, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (50% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03033914, a Phase 1 study of Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
- 10
- Study locations
Study Summary
The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether including nivolumab in treatment for untreated Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2 cycles of ABVD.
Primary Outcome
For this objective, the standard 3+3 scheme will be used. Initially, 3 patients will enroll onto dose level 1. If no patients experience DLT, enrollment will proceed to the next dose level. If 1 DLT is observed, 3 additional patients will enroll onto dose level 1. If 1 or fewer patients out of 6 experience DLT, enrollment will proceed to the next dose level. If 2 or more DLTs are observed at a given dose level, the previous dose will be declared the MTD. Adverse events will be assessed according
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG doxorubicin
- DRUG Bleomycin
- DRUG vinblastine
- DRUG dacarbazine
Study Locations (10)
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Hackensack Meridian Health - Hackensack
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Michigan
- Karmanos Cancer Institute - Detroit
Other
- BC Cancer (Data Collection Only) - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2017-01-25 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What the registry record for NCT03033914 still lists
NCT03033914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Nivolumab is the first listed.
NCT03033914 lists 10 locations in 4 states (New Jersey, New York, Michigan).
Frequently Asked Questions
What is clinical trial NCT03033914 about?
NCT03033914 is a clinical study titled "A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)". The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study i...
What is the current status of trial NCT03033914?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2017-01-25. Estimated completion is 2027-01.
What conditions does trial NCT03033914 study?
This clinical trial studies the following conditions: Hodgkin Lymphoma.
What interventions are being tested in trial NCT03033914?
The interventions under investigation include: Nivolumab (DRUG), doxorubicin (DRUG), Bleomycin (DRUG), vinblastine (DRUG), dacarbazine (DRUG).
Who is sponsoring clinical trial NCT03033914?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03033914 being conducted?
This trial has 10 study locations across Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03033914's enrollment target sits among peer trials
82 24th of 71 higher than 47 of 71 other Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hodgkin Lymphoma 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.
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