CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
filgrastim +8 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00423514
NCT00423514Phase 2Completed

A Phase I/II Dose Escalation Trial of Clofarabine, in Addition to Melphalan and Thiotepa as Myeloablative Regimen Followed by an Allogeneic Unmodified Hematopoietic Stem Cell Transplant From HLA-Compatible Related or Unrelated Donors for the Treatment of High Risk and/or Advanced Hematologic Malignancies

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 18, 2007·Updated Dec 27, 2022

In Brief

A Phase 2 clinical trial evaluating filgrastim, clofarabine, and 7 other interventions for Graft Versus Host Disease and 2 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with melphalan and thiotepa, followed by a donor stem cell transplant and to see how well it works in treating patients with high-risk and/or advanced hematologic cancer or other disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartNov 20, 2006
Primary CompletionJun 18, 2021
TodayJul 2, 2026
Enrollment to primary: 14.6 yearsPosted 19.5 years ago

Interventions

filgrastimbiological

clofarabinedrug

melphalandrug

mycophenolate mofetildrug

tacrolimusdrug

thiotepadrug

allogeneic bone marrow transplantationprocedure

allogeneic hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure