CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Alemtuzumab +3 moredrug
Likely dose
Alemtuzumab 100mLfrom 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/NCT01877837
NCT01877837Phase 3Completed
CompareCT.gov

Reduced Intensity Matched Sibling Bone Marrow Transplantation for Sickle Cell Anemia in Patients 2-30 Years Old

Hackensack Meridian Health·interventional·Posted Jun 14, 2013·Updated Nov 7, 2022

In Brief

A Phase 3 clinical trial evaluating Alemtuzumab, Fludarabine, and 2 other interventions for Sickle Cell Disease. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to vaso-occlusion, which causes irreversible damage in almost all systems in the body, including the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2013
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 13.0 years ago

Interventions

Alemtuzumabdrug

Adjusted Ideal Body Weight Formula: AIBW = IBW + \[(0.4) x (ABW - IBW)\] b) Medications i.) Alemtuzumab I. Hb S% must be \< or = 45% within 7 days prior to initiation of Alemtuzumab II. Iron chelation and hydroxyurea must be discontinued \>48 hours before initiating therapy III. Alemtuzumab will be diluted in 100mL of 0.9% NS and infused at a rate as below

Fludarabinedrug

I. Fludarabine should be diluted in 100 ml 0.9%NS and given over 30 minutes. II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Fludarabine

Melphalandrug

I. Melphalan should be diluted in 0.9%NS to a concentration of 0.1 -0.45 mg/mL and given over 45 minutes. \*Entire dose must be infused within 60 minutes of reconstitution in Pharmacy. II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Melphalan III. Patients should be encouraged to suck on a popsicle or something similar during the Melphalan infusion.

Stem Cellsprocedure

Infusion of Hematopoietic Stem Cells