Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)

Phase 2

Completed

• Conditions: Non-Hodgkin Lymphoma
• Interventions: Drug: Ibritumomab Tiuxetan (Zevalin)

• Registration Number: NCT00644371
• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Primary Completion: 2011-02-21
• Study Completion: 2013-02-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ibritumomab Tiuxetan (Zevalin)	-

Primary Outcome Measures

Name	Time	Method
progression-free survival	12 months

Secondary Outcome Measures

Name	Time	Method
acute and chronic Graft-versus-Host Disease	36 months
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
the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival	36 months
haematological and immunological reconstitution, and chimerism.	Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.

Trial Locations

Locations (14)

H. Santa Creu i Sant Pau.; 🇪🇸 Barcelona, Barcelona., Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

H.U. Gregorio Marañón; 🇪🇸 Madrid, Spain

H.U. 12 de Octubre; 🇪🇸 Madrid, Spain

H.U. La Princesa; 🇪🇸 Madrid, Spain

H.U. Ramón y Cajal.; 🇪🇸 Madrid, Spain

H. Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

H. Morales Meseguer.; 🇪🇸 Murcia, Spain

H. Central de Asturias; 🇪🇸 Oviedo, Spain

H. Clinico de Salamanca; 🇪🇸 Salamanca, Spain

H. U. Marqués de Valdecilla.; 🇪🇸 Santander, Spain

H.U. Miguel Servet; 🇪🇸 Zaragoza., Spain

H. La Fe; 🇪🇸 Valencia, Spain

H. Clínico Valencia; 🇪🇸 Valencia, Spain