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NCT02561273 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
A Phase 1 study of Hepatosplenic T-cell Lymphoma and Anaplastic Large Cell Lymphoma, ALK-Positive, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 8
- Study locations
NCT02561273: Completed Phase 1 study of Hepatosplenic T-cell Lymphoma and Anaplastic Large Cell Lymphoma, ALK-Positive, sponsored by University of Nebraska.
NCT02561273 is a Phase 1 study of Hepatosplenic T-cell Lymphoma and Anaplastic Large Cell Lymphoma, ALK-Positive that has completed, run by University of Nebraska. The registered enrollment target is 54 participants, below the 90-participant average among 12 other Hepatosplenic T-cell Lymphoma trials with a reported enrollment target (40% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561273, a Phase 1 study of Hepatosplenic T-cell Lymphoma and Anaplastic Large Cell Lymphoma, ALK-Positive, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.
Primary Outcome
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Study Locations (8)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Stanford Cancer Institute - Palo Alto
Colorado
- University of Colorado Cancer Center, Anschutz Cancer Pavilion - Aurora
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University School of Medicine - St Louis
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-09-28 |
| Est. Completion | 2020-11-01 |
| Phase | Phase 1 |
What the finished NCT02561273 record still lists
NCT02561273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 90-participant average among 12 other Hepatosplenic T-cell Lymphoma trials with a reported enrollment target (40% lower).
The record links to 10 conditions, with Hepatosplenic T-cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02561273 lists 8 locations in 7 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT02561273 about?
NCT02561273 is a clinical study titled "Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma". This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosph...
What is the current status of trial NCT02561273?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-09-28. Estimated completion is 2020-11-01.
What conditions does trial NCT02561273 study?
This clinical trial studies the following conditions: Hepatosplenic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Anaplastic Large Cell Lymphoma, ALK-negative, Stage II Angioimmunoblastic T-cell Lymphoma.
What interventions are being tested in trial NCT02561273?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02561273?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02561273 being conducted?
This trial has 8 study locations across California, Colorado, Georgia, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02561273's enrollment target sits among peer trials
54 6th of 12 higher than 7 of 12 other Hepatosplenic T-cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatosplenic T-cell 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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