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Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAPLO group | Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013 | ||
| MUD group | Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012 | ||
| MMUD group | Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 | ||
| UCB group | Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 |
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| Measure | Description | Time Frame |
|---|---|---|
| Transplant-related mortality | Up to 12 months after the transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 12 months after the transplantation | |
| Incidence of acute and chronic graft versus host disease | Up to 12 months after the transplantation | |
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Inclusion Criteria:
Any of the following hematologic malignancies:
Patient received any of the following transplantations:
Male or female, age ≥ 18, ≤ 65 years.
Exclusion Criteria:
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Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Rovers, MD | Kiadis Pharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States | ||
| Algemeen Ziekenhuis Sint-Jan |
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| Progression-free survival |
| Up to 12 months after the transplantation |
| Severity of acute and chronic graft versus host disease | Up to 12 months after the transplantation |
| Relapse-related mortality | Up to 12 months after the transplantation |
| Bruges |
| 8000 |
| Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Universitair Ziekenhuis Gasthuisberg | Leuven | 3000 | Belgium |
| Hamilton Niagara Regional Haemophilia Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Hammersmith Hospital | London | W12 OHS | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D006086 | Graft vs Host Disease |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D009371 | Neoplasms by Site |
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