Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

NACompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2014

Conditions
Acute Lymphoblastic Leukemia
Interventions
PROCEDURE

Transplantation with Stem Cells from Umbilical Cord

"According to results from published experiences in children following suggestions are given:~1. Number of Cells:~ * Number of nucleated cells infused exceed 2,5x10\*7/kg recipient BW or~ * Number of nucleated cells collected exceed 3x10\*7/kg BW~ * Number of CD34+ cells infused exceed 2x10\*5/kg Recipient BW~2. GVHD-prophylaxis:~ • MSD: CSA 3 mg/kg as described in the protocol + Prednisolone 1 mg/kg (day O to day 15, then tapering until day 28)~ • UD: as above + additional immunosuppression according to local protocols; ATG might increase risk of infectious complication and might be replaced by other drugs according to local protocols.~3. HLA-matching for unrelated CB: a matched UB is defined by 6/6 HLA matches (A, B antigenic medium resolution and DRB1 allelic) and allocate to the transplantation group MD. Less than 6/6 HLA matches allocate the patient to the MMD group.~4. If many choices available ABO- major incompatibility should be avoided."

Trial Locations (1)

49202

Schneider Children's Medical Center of Israel, Petach Tikvah

All Listed Sponsors
lead

Hadassah Medical Organization

OTHER

NCT00861679 - Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International | Biotech Hunter | Biotech Hunter