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low rate of enrolment
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TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT).
The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Treatment | Experimental | Conditioning treatment "Treosulfan+TMI"; SCT; GvHD prophylaxis; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conditioning treatment "Treosulfan-TMI" | Drug | Treosulfan i.v.: 14 g/m²/d (day -6 to -4) Fludarabine i.v.: 30 mg/m²/d (day -6 to -2) Antithymocyte globulin (ATG)-Fresenius i.v.: 5/0 mg/kg (day -4 to -2) Mabthera i.v.: 200/0* mg/m2 (day -1) TMI: (10 Gy) 2 Gy bis in die (BID) (day -2 to -1) or TMI: (12 Gy) 2 Gy BID (day -3 to -1) or TMI: (14 Gy) 2 Gy BID (day -3 to -1) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the maximum tolerated dose of TMI (FEASIBILITY of TMI) | To determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule | From administration of TMI (-5) to transplant |
| Rate of Survival post transplant | Evaluation of survival and engraftment | +30 days post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - progression free survival (PFS) | PFS | End of total follow-up is 365 days after transplantation of the last patient included |
| Efficacy - Overall survival (OS) | OS |
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Inclusion Criteria:
Patients with haematological malignancies such as
Karnofsky Index ≥ 80 %
Adequate contraception in female patients of child-bearing potential.
Written informed consent
Availability of one of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| SCT | Procedure | Stem Cell Transplant |
|
| GvHD prophylaxis | Drug | Rapamycin p.o.: 4 mg/d, (target 8-15 ng/ml) (starting day -7) Mycofenolate mofetile: 10 mg/kg tid, (Maximum dose 720 mg/tid) (starting from day 0) |
|
| End of total follow-up is 365 days after transplantation of the last patient included |
| Efficacy - Relapse incidence (RI) | RI | End of total follow-up is 365 days after transplantation of the last patient included |
| Evaluation of Transplant Safety - incidence of non-relapse mortality (NRM) | Evaluation of incidence of NRM | Eon day +28, day +100 and +360 |
| Evaluation of Transplant Safety | Cumulative of incidence and cumulative severity of GvHD | End of total follow-up is 365 days after transplantation of the last patient included |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |