Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Procedure: Transplantation with Stem Cells from Umbilical Cord


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HSCT from matched family or unrelated donors(MD)<br>HSCT from matched family or unrelated donors(MD) to matched related donors. | Procedure: Transplantation with Stem Cells from Umbilical Cord<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSCT, ALL, GvHD