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The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treosulfan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treosulfan | Drug | 12 g/m2 x 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| treatment-related mortality | 2 year after transplantation | |
| GVHD | 2 year after transplantation | |
| relapse |
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Inclusion Criteria:
Age less than physiologic 68 years.
Patients with NHL and HL with an indication for allogeneic transplantation as follows:
Disease must be at chemo-sensitive or stable status to prior therapy before transplant.
Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient
Patients must sign written informed consent
Adequate birth control in fertile patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnon Nagler, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Tel Litwinsky | Tel-Hashomer | 52621 | Israel |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C018404 | treosulfan |
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| 2 year after transplantation |
| overall survival | 2 year after transplantation |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |