Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Z-RIC-Allo
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
2 other identifiers
interventional
20
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2007
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2013
CompletedMarch 27, 2017
March 1, 2017
3.3 years
March 18, 2008
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
12 months
Secondary Outcomes (7)
safety (toxicity, transplantation- and graft-related mortality)
36 months
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
36 months
overall survival
36 months
relapse rate
36 months
acute and chronic Graft-versus-Host Disease
36 months
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Conditioning Regimen 1. Rituximab, 250 mg/m2 on days -21 and -14. 2. Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14. Chemotherapy: * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion. Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months: * Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8. * Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion. * Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
H. Santa Creu i Sant Pau.
Barcelona, Barcelona., Spain
H. U. Marqués de Valdecilla.
Santander, Cantabria, Spain
H.U. 12 de Octubre
Madrid, Madrid, Spain
H.U. Gregorio Marañón
Madrid, Madrid, Spain
H.U. La Princesa
Madrid, Madrid, Spain
H.U. Ramón y Cajal.
Madrid, Madrid, Spain
H. Morales Meseguer.
Murcia, Murcia, Spain
H. Virgen de la Arrixaca
Murcia, Murcia, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
H. Central de Asturias
Oviedo, Oviedo, Spain
H. Clinico de Salamanca
Salamanca, Salamanca, Spain
H. Clínico Valencia
Valencia, Valencia, Spain
H. La Fe
Valencia, Valencia, Spain
H.U. Miguel Servet
Zaragoza, Zaragoza., Spain
Related Publications (1)
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.
PMID: 27771496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dolores Caballero, MD
Hospital Clínico Universitario de Salamanca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 26, 2008
Study Start
November 1, 2007
Primary Completion
February 21, 2011
Study Completion
February 4, 2013
Last Updated
March 27, 2017
Record last verified: 2017-03