Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Medical Center of Israel

Petach Tikvah, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

age at time of initial diagnosis or relapse diagnosis, respectively

≤18 years

indication for allogeneic HSCT
complete remission (CR) is achieved before SCT
written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
no pregnancy
no secondary malignancy
no previous HSCT
HSCT is performed in a study participating centre.

Exclusion criteria

not signed inform consent of the parents (legal guardian)
pregnancy
secondary malignancy
previous HSCT

Treatment and study plan

Transplantation with Stem Cells from Umbilical Cord

Procedure

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
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.
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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study 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)

Acronym: ALL SCT BFM

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2014
First posted: Mar 13, 2009
Registry last updated: Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed