Clinical trial · Interventional
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma
NCT00644371CI-TRIAL-00026627Z-RIC-AllocompletedPhase 2ClinicalTrials.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)
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) | Drug | Ibritumomab Tiuxetan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Ibritumomab Tiuxetan (Zevalin)
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 12 months
Secondary outcomes (7)
- measure
- safety (toxicity, transplantation- and graft-related mortality)
- timeFrame
- 36 months
- measure
- response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent 2. Histologically confirmed B-cell lymphoma of the following subtypes: * LBCDL * Grade 3b follicular lymphoma * Mantle-cell lymphoma * Transformed B-cell lymphoma * Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant 3. High-risk B-cell CD20+ lymphoma defined by * Having attained less than PR after two chemotherapy lines * Post-transplantation relapse * Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation * Inability to collect enough stem cells for autologous transplantation 4. Stable disease at the time of transplantation 5. Age between 18 and 65 6. Performance status (ECOG) ≤ 2 7. Normal and suitable pulmonary function (DLCO ≥ 30%) 8. Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40% 9. Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration) Exclusion Criteria: 1. Prior treatment with radiopharmaceutical agents 2. HIV-associated lymphoma 3. Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA) 4. Patient's inability to follow the protocol 5. Hypersensitivity to 90Y-itritumomab tiuxetan 6. Presence of severe pathologies that preclude chemotherapeutic treatment 7. Pregnant women or pregnancy risk due to inappropriate contraceptive measures 8. Breastfeeding women
References
Publications (1)
- DERIVEDCabrero M, Martin A, Briones J, Gayoso J, Jarque I, Lopez J, Grande C, Heras I, Arranz R, Bernal T, Perez-Lopez E, Lopez-Godino O, Conde E, Caballero D. Phase II Study of Yttrium-90-Ibritumomab Tiuxetan as Part of Reduced-Intensity Conditioning (with Melphalan, Fludarabine +/- Thiotepa) for Allogeneic Transplantation in Relapsed or Refractory Aggressive B Cell Lymphoma: A GELTAMO Trial. Biol Blood Marrow Transplant. 2017 Jan;23(1):53-59. doi: 10.1016/j.bbmt.2016.10.003. Epub 2016 Oct 19. PMID 27771496