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NCT00492856 · ClinicalTrials.gov registry record · Phase 3
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
A Phase 3 study of Leukemia, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT00492856: Completed Phase 3 study of Leukemia, sponsored by SWOG Cancer Research Network.
NCT00492856 is a Phase 3 study of Leukemia that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 105 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492856, a Phase 3 study of Leukemia, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Primary Outcome
DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of
Conditions Studied
Interventions
- DRUG mercaptopurine
- DRUG methotrexate
- DRUG tretinoin
Study Locations (20)
Illinois
- Hematology Oncology Associates of Illinois - Berwyn - Berwyn
- Illinois CancerCare - Bloomington - Bloomington
- St. Joseph Medical Center - Bloomington
- Graham Hospital - Canton
- Illinois CancerCare - Canton - Canton
- Illinois CancerCare - Carthage - Carthage
- Memorial Hospital - Carthage
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
- Hematology and Oncology Associates - Chicago
- University of Chicago Cancer Research Center - Chicago
- Decatur Memorial Hospital Cancer Care Institute - Decatur
- Eureka Community Hospital - Eureka
- Illinois CancerCare - Eureka - Eureka
California
- Sutter Cancer Center at Roseville Medical Center - Roseville
- Sutter Cancer Center - Sacramento
- Stanford Cancer Center - Stanford
Delaware
- Tunnell Cancer Center at Beebe Medical Center - Lewes
- CCOP - Christiana Care Health Services - Newark
Arizona
- Mayo Clinic Scottsdale - Scottsdale
District of Columbia
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2007-06-01 |
| Est. Completion | 2016-05-04 |
| Phase | Phase 3 |
What the finished NCT00492856 record still lists
NCT00492856 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which mercaptopurine is the first listed.
NCT00492856 names 20 study sites across 5 states, led by Illinois, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT00492856 about?
NCT00492856 is a clinical study titled "S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spr...
What is the current status of trial NCT00492856?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2007-06-01. Estimated completion is 2016-05-04.
What conditions does trial NCT00492856 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00492856?
The interventions under investigation include: mercaptopurine (DRUG), methotrexate (DRUG), tretinoin (DRUG).
Who is sponsoring clinical trial NCT00492856?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00492856 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00492856's enrollment target sits among peer trials
105 55th of 233 higher than 178 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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