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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSCT from matched family or unrelated donors(MD) | Other | HSCT from matched family or unrelated donors(MD) to matched related donors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation with Stem Cells from Umbilical Cord | Procedure | According to results from published experiences in children following suggestions are given:
|
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Petach Tikvah | 49202 | Israel |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |