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The study hypotheses is that the introduction of dose escalated thiotepa, 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 |
|---|---|---|---|
| thiotepa | Experimental | Thiotepa 5-10 mg/kg/d x 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiotepa | Drug | Chemotherapy given prior to allogeneic stem cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | The percentage of patients alive without disease recurrence 2 years after transplant | 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| treatment-related mortality | The percentage of patients who die of complications related to the transplant | 2 years after transplantation |
| graft versus host disease | The percentage of patients experiencing graft-versus-host disease after transplant |
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Inclusion Criteria:
Age less than physiologic 68 years.
Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
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, -DQB) 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Avichai Shimoni, MD | Contact | 972 3 530 5830 | ashimoni@sheba.health.gov.il | |
| Arnon Nagler, MD | Contact | 9972 3 530 5830 | a.nagler@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Arnon Nagler, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D013852 | Thiotepa |
| ID | Term |
|---|---|
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
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| 1 year after transplantation |
| relapse | The percentage of patients experiencing disease recurrence after transplant | 2 years after transplantation |
| Chaim Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001388 |
| Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |