Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT00006363. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC # 648265, IND # 41121) Followed by Cytogenetic Risk-Adapted Intensification Therapy Followed by Immunotherapy With rIL-2 (NSC # 373364, IND # 1969) vs. Observation in Previously Untreated Patients With AML < 60 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00006363
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 720 participants
Conditions and interventions
Conditions
- Adult Acute Basophilic Leukemia
- Adult Acute Eosinophilic Leukemia
- Adult Acute Erythroid Leukemia (M6)
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Acute Myelomonocytic Leukemia (M4)
- Adult Erythroleukemia (M6a)
- Adult Pure Erythroid Leukemia (M6b)
- Childhood Acute Basophilic Leukemia
- Childhood Acute Eosinophilic Leukemia
- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia With Maturation (M2)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myelomonocytic Leukemia (M4)
- Childhood Myelodysplastic Syndromes
- de Novo Myelodysplastic Syndromes
- Untreated Adult Acute Myeloid Leukemia
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions
- cytarabine Drug
- daunorubicin hydrochloride Drug
- etoposide Drug
- valspodar Drug
- filgrastim Biological
- busulfan Drug
- autologous hematopoietic stem cell transplantation Procedure
- peripheral blood stem cell transplantation Procedure
- aldesleukin Biological
- clinical observation Other
- pharmacological study Other
Drug · Biological · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 15 Years to 59 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2000
- Primary completion
- May 31, 2005
- Completion
- Not listed
- Last update posted
- Jun 3, 2013
Started 2000
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cancer and Leukemia Group B | Chicago | Illinois | 60606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00006363, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006363 live on ClinicalTrials.gov.