Clinical trial NCT00644371: Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Keywords: Allogeneic
Lymphoma
GELTAMO
Z-RIC
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 haematopoietic stem cells from family donor's peripheral blood.


Eligibility criteria: 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

Primary outcomes:
measure: progression-free survival
timeFrame: 12 months
Secondary outcomes:
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
measure: overall survival
timeFrame: 36 months
measure: relapse rate
timeFrame: 36 months
measure: acute and chronic Graft-versus-Host Disease
timeFrame: 36 months
measure: haematological and immunological reconstitution, and chimerism.
timeFrame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
measure: the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: H. Santa Creu i Sant Pau.
state: Barcelona.
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Madrid
country: Spain
facility: H.U. 12 de Octubre
city: Madrid
country: Spain
facility: H.U. Gregorio Marañón
city: Madrid
country: Spain
facility: H.U. La Princesa
city: Madrid
country: Spain
facility: H.U. Ramón y Cajal.
city: Murcia
country: Spain
facility: H. Morales Meseguer.
city: Murcia
country: Spain
facility: H. Virgen de la Arrixaca
city: Oviedo
country: Spain
facility: H. Central de Asturias
city: Salamanca
country: Spain
facility: H. Clinico de Salamanca
city: Santander
country: Spain
facility: H. U. Marqués de Valdecilla.
city: Valencia
country: Spain
facility: H. Clínico Valencia
city: Valencia
country: Spain
facility: H. La Fe
city: Zaragoza.
country: Spain
facility: H.U. Miguel Servet
Study officials:
affiliation: Hospital Clínico Universitario de Salamanca
name: Dolores Caballero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabrero 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.