CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
AMD3100 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Recipient aged 18 to 65 years inclusive
  • ✓6/6 HLA-matched sibling willing to donate peripheral blood stem cells for transplant
  • ✓Diagnosed with AML, ALL, MDS, CML, NHL, HD, CLL, or MM with defined disease status/risk
  • ✓ECOG performance status 0 or 1
Key exclusion· 4
  • ✕Active alcohol or substance abuse within 6 months of study entry
  • ✕Concurrently enrolled in another investigational agent study
  • ✕Severe or symptomatic restrictive or obstructive lung disease
  • ✕History of cerebrovascular accident or seizure disorder requiring anticonvulsant medication (donor); evidence of severe central or peripheral neurologic abnormality (recipient)

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

Search/NCT00241358
NCT00241358Phase 2Completed
CompareCT.gov

A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies

Washington University School of Medicine·interventional·Posted Oct 18, 2005·Updated Jun 6, 2017

In Brief

A Phase 2 clinical trial evaluating AMD3100 and Stem Cell Transplant for Leukemia, Myeloid, Acute and 7 related conditions. Completed, enrolled 92 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Leukemia, Lymphoblastic, Acute, Lymphocytic Leukemia, Chronic, Myelodysplastic Syndromes, Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartMay 1, 2004
Primary CompletionDec 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 20.7 years ago

Interventions

AMD3100drug

Stem Cell Transplantprocedure