CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 75 enrolled
Drug / intervention
fludarabine phosphate +3 moredrug
Likely dose
fludarabine phosphate 25 mg/m2from 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/NCT00544466
NCT00544466Phase 2Active

Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies

City of Hope Medical Center·interventional·Posted Oct 16, 2007·Updated Feb 19, 2026

In Brief

A Phase 2 clinical trial evaluating fludarabine phosphate, melphalan, and 2 other interventions for Leukemia and Myelodysplastic Syndromes. Active but no longer recruiting, targeting 75 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer 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 make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening. PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.

Study Details

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

Timeline

Phase 2Active
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2007
Enrollment StartJul 31, 2006
Primary CompletionAug 1, 2013
Study CompletionDec 2, 2026
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 18.7 years ago

Interventions

fludarabine phosphatedrug

25 mg/m2 day -7 through day -3 prior to transplant

melphalandrug

140 mg/m2 day -2 prior to transplant

allogeneic hematopoietic stem cell transplantationprocedure

Cells infused on Day 0 of transplant regimen

intensity-modulated radiation therapyradiation

Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant