Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Procedure: Transplantation with Stem Cells from Umbilical Cord

• Registration Number: NCT00861679
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Status Verified: 2009-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2009-09
• Study Completion: 2014-09
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSCT from matched family or unrelated donors(MD)	Transplantation with Stem Cells from Umbilical Cord	HSCT from matched family or unrelated donors(MD) to matched related donors.

Primary Outcome Measures

Name	Time	Method
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	11 years

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikvah, Israel