Clinical trial · Interventional
Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors
NCT00354120CI-TRIAL-00064618GLOBALcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloblastic Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Lympho-proliferative Diseases | — | UNRESOLVED | — |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alentuzumab | Drug | — | UNRESOLVED |
| Globulina antilinfocitaria | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Alentuzumab
- interventionNames
- Drug: Alentuzumab
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Globulina antilinfocitaria
- interventionNames
- Drug: Globulina antilinfocitaria
Primary outcomes (5)
- measure
- Overall Survival
- timeFrame
- 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual) * Group 2: patients \<= 65 yo suffering from lympho-proliferative diseases according the REAL classification: * High-doses chemotherapy relapsed CLL (B and T) * Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy * Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy * Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy * Advanced (stage ≥ III A) or relapsed T lymphomas * Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens * Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy * Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells. Exclusion Criteria: * Performance status \< 70% (Karnofsky) * Left ventricular cardiac ejection fraction \< 40% or receiving treatment for heart failure * DLCO pulmonary \< 40% or receiving continuous oxygen therapy * Neuropathy (previous or at present) * Pregnancy * Patients with arterial hypertension not controlled with multi-pharmacological treatments * HIV positive * B-CLL with clear evidence of transformation into Richter syndrome * Mycosis fungoides with clear evidence of transformation into blasts * Hodgkin's disease refractory to chemotherapy * Absence of informed consent * Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment
References
Publications (0)
Data not yet available
No reference posted for this study.