NCT00861679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2009

Enrollment Period

2.7 years

First QC Date

March 12, 2009

Last Update Submit

March 24, 2021

Conditions

Acute Lymphoblastic Leukemia

Keywords

HSCTALLGvHD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

HSCT from matched family or unrelated donors(MD)

OTHER

HSCT from matched family or unrelated donors(MD) to matched related donors.

Procedure: Transplantation with Stem Cells from Umbilical Cord

Interventions

Transplantation with Stem Cells from Umbilical CordPROCEDURE

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.

HSCT from matched family or unrelated donors(MD)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petach Tikvah, 49202, Israel

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2014

Last Updated

March 29, 2021

Record last verified: 2009-03

Locations

IL(1)