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Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

NCT00861679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2021-03-29

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-09-30
Completion
2014-09-30

Countries

  • Israel

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861679 on ClinicalTrials.gov