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S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
NCT00492856 · View on ClinicalTrials.gov ↗
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00492856
The ClinicalTrials.gov registry entry for NCT00492856 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00492856 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Illinois, California, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00492856?
The interventions under investigation include: mercaptopurine (DRUG), methotrexate (DRUG), tretinoin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00492856?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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