NL-OMON32010
Completed
Phase 2
Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- minitransplantation / GvHD
- Sponsor
- Academisch Ziekenhuis Maastricht
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hematological malignancies confirmed histologically and not rapidly progressing:
- •\- AML in CR (defined as \* 5% marrow blasts and absence of blasts in the peripheral blood);
- •\- MDS with \* 5% marrow blasts and absence of blasts in the peripheral blood;
- •\- CML in CP;
- •\- MPS not in blast crisis and not with extensive marrow fibrosis,
- •\- ALL in CR;
- •\- Multiple myeloma not rapidly progressing;
- •\- Non\-Hodgkin\*s lymphoma (aggressive NHL should have chemosensitive disease);
- •\- Hodgkin\*s disease with chemosensitive disease.;Clinical situations
- •· Theoretical indication for a standard allo\-transplant, but not feasible because:
Exclusion Criteria
- •· Any condition not fulfilling inclusion criteria;
- •· HIV positive;
- •· Non\-hematological malignancy(ies) (except non\-melanoma skin cancer) \< 3 years before nonmyeloablative HCT.
- •· Life expectancy severely limited by disease other than malignancy;
- •· Administration of cytotoxic agent(s) for \*cytoreduction\* within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
- •· CNS involvement with disease refractory to intrathecal chemotherapy.
- •· Terminal organ failure, except for renal failure (dialysis acceptable)
- •a. Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction \<35%; uncontrolled arrhythmia, uncontrolled hypertension;
- •b. Pulmonary: DLCO \< 35% and/or receiving supplementary continuous oxygen;
- •c. Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \>3 mg/dL, and symptomatic biliary disease;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLIPatients with hematological malignancies not candidate for conventional allogeneic transplantation because of age or comorbiditiesMedDRA version: 9.1Level: LLTClassification code 10001756Term: Allogenic bone marrow transplantation therapyEUCTR2007-002548-12-BECHU-ULG60
Active, not recruiting
Phase 1
Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLIPatients with hematological malignancies not candidate for conventional allogeneic transplantation because of age or comorbiditiesMedDRA version: 9.1Level: LLTClassification code 10001756Term: Allogenic bone marrow transplantation therapyEUCTR2007-002548-12-NLCHU-ULG107
Active, not recruiting
Not Applicable
Allogeneic Hematopoietic Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic Malignancies - NDPreparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic MalignanciesMedDRA version: 6.1Level: PTClassification code 10028228EUCTR2007-005563-10-ITFONDAZIONE NEOPLASIE SANGUE ONLUS
Active, not recruiting
Not Applicable
Allogeneic Haematopoietic Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Refractory ?Triple Negative? Breast Cancer - NDPatients with Refractory ?Triple Negative? Breast CancerMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancerEUCTR2008-006262-28-ITISTITUTO EUROPEO DI ONCOLOGIA
Active, not recruiting
Phase 1
Comparison of two methods for the prevention of graft-versus-host reactions after bone marrow transplantation.Hematologic malignancies treated by reduced-intensity conditioning allogeneic transplants.MedDRA version: 18.0Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.0Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-024297-19-BECHU de Liege200