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NCT00049517 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
A Phase 3 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 657
- Enrollment target
NCT00049517 is a Phase 3 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 657 participants.
The verdict
NCT00049517, a Phase 3 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 657 participants
- Enrollment target
Study Summary
RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.
Interventions
- DRUG cyclophosphamide
- DRUG cytarabine
- DRUG busulfan
- BIOLOGICAL sargramostim
- DRUG gemtuzumab ozogamicin (GO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2002-12-19 |
| Est. Completion | 2019-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00049517
The ClinicalTrials.gov registry entry for NCT00049517 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 657 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00049517 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00049517 about?
NCT00049517 is a clinical study titled "Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia". RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow ...
What is the current status of trial NCT00049517?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 657 participants. The study started on 2002-12-19. Estimated completion is 2019-12.
What interventions are being tested in trial NCT00049517?
The interventions under investigation include: cyclophosphamide (DRUG), cytarabine (DRUG), busulfan (DRUG), sargramostim (BIOLOGICAL), gemtuzumab ozogamicin (GO) (DRUG).
Who is sponsoring clinical trial NCT00049517?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
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