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NCT00006363 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
A Phase 3 study of Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Monocytic Leukemia (M5b), sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
- 1
- Study location
NCT00006363: Completed Phase 3 study of Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Monocytic Leukemia (M5b), sponsored by National Cancer Institute (NCI).
NCT00006363 is a Phase 3 study of Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Monocytic Leukemia (M5b) that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 720 participants, above the 136-participant average among 8 other Adult Acute Minimally Differentiated Myeloid Leukemia (M0) trials with a reported enrollment target (429% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006363, a Phase 3 study of Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Monocytic Leukemia (M5b), has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
- 1
- Study location
Study Summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. This randomized phase III trial is studying giving combination chemotherapy together with PSC 833 followed by a peripheral stem cell transplant with or without interleukin-2 to see how well it works compared to combination chemotherapy alone followed by a peripheral stem cell transplant with or without interleukin-2 in treating patients with acute myeloid leukemia.
Primary Outcome
An unstratified logrank test for the induction treatment comparison and a stratified logrank test for the post-remission treatment comparison will be the primary statistical methods used for treatment comparisons.
Conditions Studied
Interventions
- DRUG etoposide
- BIOLOGICAL filgrastim
- DRUG cytarabine
- DRUG daunorubicin hydrochloride
- DRUG valspodar
Study Locations (1)
Illinois
- Cancer and Leukemia Group B - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2000-11 |
| Phase | Phase 3 |
What the finished NCT00006363 record still lists
NCT00006363 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 8 other Adult Acute Minimally Differentiated Myeloid Leukemia (M0) trials with a reported enrollment target (429% higher).
The record links to 10 conditions, with Adult Acute Minimally Differentiated Myeloid Leukemia (M0) appearing as the primary indexed condition, and to 5 interventions - of which etoposide is the first listed.
NCT00006363 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00006363 about?
NCT00006363 is a clinical study titled "Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia". Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs. Combining chemotherapy with peripheral stem cell transplantation may allow the doct...
What is the current status of trial NCT00006363?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2000-11.
What conditions does trial NCT00006363 study?
This clinical trial studies the following conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Megakaryoblastic Leukemia (M7).
What interventions are being tested in trial NCT00006363?
The interventions under investigation include: etoposide (DRUG), filgrastim (BIOLOGICAL), cytarabine (DRUG), daunorubicin hydrochloride (DRUG), valspodar (DRUG).
Who is sponsoring clinical trial NCT00006363?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006363 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00006363's enrollment target sits among peer trials
720 1st of 8 higher than 8 of 8 other Adult Acute Minimally Differentiated Myeloid Leukemia (M0) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Minimally Differentiated Myeloid Leukemia (M0) 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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