Clinical trial
Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell…
NCT00006363 · National Cancer Institute (NCI), NIH · Completed
Key facts
| NCT number | NCT00006363 |
|---|---|
| Title | Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia |
| 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… |
| Lead sponsor | National Cancer Institute (NCI), NIH |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| 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) and 26 more |
| Intervention type | Biological, Drug, Other, Procedure |
| Interventions | cytarabine, daunorubicin hydrochloride, etoposide, valspodar, filgrastim, busulfan, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, aldesleukin, clinical observation and 1 more |
| Enrollment | 720 |
| Start date | Nov 1, 2000 |
| Primary completion | Jun 1, 2005 |
| First posted | Jan 27, 2003 |
| Last update posted | Jun 4, 2013 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: