CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 546 enrolled
Drug / intervention
Busulfan +9 moredrug
Likely dose
Decitabine given IV (specific dose not stated in interventions)AI-extracted
Key inclusion· 5
  • ✓Unequivocal histologic diagnosis of AML with >20% blasts in bone marrow (WHO and/or FAB classification), excluding M3 (acute promyelocytic leukemia)
  • ✓No prior azacitidine or decitabine therapy
  • ✓Age <60 years
  • ✓Patients with antecedent myelodysplasia eligible only if no bone marrow biopsy showing MDS >3 months prior to enrollment
Key exclusion· 1
  • ✕Prior treatment for leukemia or MDS, except emergency leukapheresis, emergency hydroxyurea for hyperleukocytosis, cranial RT for CNS leukostasis (one dose only), or growth factor/cytokine support

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00416598
NCT00416598Phase 2Completed
CompareCT.gov

Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML &lt; 60 Years

National Cancer Institute (NCI)·interventional·Posted Dec 28, 2006·Updated Feb 19, 2019

In Brief

A Phase 2 clinical trial evaluating Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, and 8 other interventions for Acute Myeloid Leukemia and 6 related conditions. Completed, enrolled 546 participants across 46 sites.

Detailed Summary

This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartNov 15, 2006
Primary CompletionJan 31, 2011
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 19.5 years ago

Interventions

Autologous Bone Marrow Transplantationprocedure

Undergo autologous bone marrow transplantation

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous PBSC transplantation

Busulfandrug

Given IV

Cytarabinedrug

Given IV

Daunorubicin Hydrochloridedrug

Given IV

Decitabinedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies