CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Stem Cell Transplant +1 morebiological
Likely dose
Busulfan, cyclophosphamide, melphalan, and anti-thymocyte globulin (ATG) as preparative regimen; stem cell transplant on Day 0AI-extracted
Key inclusion· 7
  • ✓Diagnosis of JMML meeting international diagnostic criteria: leukocytosis >13,000 with absolute monocytosis >1,000
  • ✓Presence of immature myeloid cells in peripheral blood
  • ✓Less than 30% marrow blasts
  • ✓Absence of t(9;22) or BCR-ABL transcript
Key exclusion· 1
  • ✕Active uncontrolled infection within one week of transplant

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

Search/NCT00167219
NCT00167219Phase 2Completed
CompareCT.gov

Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia

Masonic Cancer Center, University of Minnesota·interventional·Posted Sep 14, 2005·Updated Nov 7, 2023

In Brief

A Phase 2 clinical trial evaluating Stem Cell Transplant and Preparative Regimen for Juvenile Myelomonocytic Leukemia. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Myelomonocytic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartNov 18, 1999
Primary CompletionJul 12, 2022
Study CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 22.7 yearsPosted 20.8 years ago

Interventions

Stem Cell Transplantbiological

Transplantation on Day 0.

Preparative Regimendrug

* Busulfan * Cyclophosphamide * Mesna * Melphalan * Anti-thymocyte Globulin (ATG)