Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International (ALL SCT BFM)
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|ClinicalTrials.gov Identifier: NCT00861679|
Recruitment Status : Unknown
Verified March 2009 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : March 13, 2009
Last Update Posted : March 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Procedure: Transplantation with Stem Cells from Umbilical Cord||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||552 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy Protocol ALL SCT BFM International-Open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||September 2014|
- Procedure: Transplantation with Stem Cells from Umbilical Cord
According to results from published experiences in children following suggestions are given:
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
• 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.
- 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.
- If many choices available ABO- major incompatibility should be avoided.
- event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 11 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861679
|Contact: Polina Y Stepensky, M.D.||firstname.lastname@example.org|
|Schneider Children's Medical Center of Israel||Recruiting|
|Petach Tikvah, Israel, 49202|
|Contact: Jerry Stein, M.D. 972-(50)-4057148 email@example.com|