Status:
COMPLETED
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 haem...
Eligibility Criteria
Inclusion
- Written informed consent
- 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
- 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
- Stable disease at the time of transplantation
- Age between 18 and 65
- Performance status (ECOG) ≤ 2
- Normal and suitable pulmonary function (DLCO ≥ 30%)
- Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
- 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
- Prior treatment with radiopharmaceutical agents
- HIV-associated lymphoma
- Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
- Patient's inability to follow the protocol
- Hypersensitivity to 90Y-itritumomab tiuxetan
- Presence of severe pathologies that preclude chemotherapeutic treatment
- Pregnant women or pregnancy risk due to inappropriate contraceptive measures
- Breastfeeding women
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00644371
Start Date
November 1 2007
End Date
February 4 2013
Last Update
March 27 2017
Active Locations (14)
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1
H. Santa Creu i Sant Pau.
Barcelona, Barcelona., Spain
2
H. U. Marqués de Valdecilla.
Santander, Cantabria, Spain
3
H.U. 12 de Octubre
Madrid, Madrid, Spain
4
H.U. Gregorio Marañón
Madrid, Madrid, Spain