CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Alemtuzumab +7 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/NCT00553098
NCT00553098Phase 2Completed
CompareCT.gov

Hematopoietic Cell Transplantation for Treatment of Patients With Primary Immunodeficiencies and Other Nonmalignant Inherited Disorders Using Low-Dose TBI and Fludarabine With or Without Campath®

Fred Hutchinson Cancer Center·interventional·Posted Nov 5, 2007·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab, Allogeneic Bone Marrow Transplantation, and 6 other interventions for Immunodeficiency Syndrome and Non-Cancer Diagnosis. Completed, enrolled 29 participants across 6 sites.

Detailed Summary

This phase II trial studies fludarabine phosphate and total-body irradiation with or without alemtuzumab followed by donor stem cell transplant to see how well it works in treating patients with immunodeficiency or other nonmalignant inherited disorders. Giving chemotherapy, such as fludarabine phosphate, a monoclonal antibody such as alemtuzumab, and radiation therapy before a donor stem cell transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunodeficiency Syndrome, Non-Cancer Diagnosis
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2007
Enrollment StartJun 1, 2006
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 18.7 years ago

Interventions

Alemtuzumabbiological

Given IV

Allogeneic Bone Marrow Transplantationprocedure

Undergo HCT

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo HCT

Cyclosporinedrug

Given PO or IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative study

Mycophenolate Mofetildrug

Given PO or IV

Total-Body Irradiationradiation

Undergo low dose TBI