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

Non-Hodgkin Lymphoma Clinical Trial

— Z-RIC-Allo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644371
• Other study ID #: GELTAMO-Z-RIC-Allo
• Secondary ID: EuDRACT nº:2007-
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: March 23, 2017
• Start date: November 2007
• Est. completion date: February 4, 2013

Study information

• Verified date: March 2017
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 4, 2013
• Est. primary completion date: February 21, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• Ibritumomab Tiuxetan (Zevalin)
Conditioning Regimen Rituximab, 250 mg/m2 on days -21 and -14. 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.

Locations

Country	Name	City	State
Spain	H. Santa Creu i Sant Pau.	Barcelona	Barcelona.
Spain	H.U. 12 de Octubre	Madrid
Spain	H.U. Gregorio Marañón	Madrid
Spain	H.U. La Princesa	Madrid
Spain	H.U. Ramón y Cajal.	Madrid
Spain	H. Morales Meseguer.	Murcia
Spain	H. Virgen de la Arrixaca	Murcia
Spain	H. Central de Asturias	Oviedo
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	H. Clinico de Salamanca	Salamanca
Spain	H. U. Marqués de Valdecilla.	Santander
Spain	H. Clínico Valencia	Valencia
Spain	H. La Fe	Valencia
Spain	H.U. Miguel Servet	Zaragoza.

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		12 months
Secondary	safety (toxicity, transplantation- and graft-related mortality)		36 months
Secondary	response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).		36 months
Secondary	overall survival		36 months
Secondary	relapse rate		36 months
Secondary	acute and chronic Graft-versus-Host Disease		36 months
Secondary	haematological and immunological reconstitution, and chimerism.		Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
Secondary	the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival		36 months