search
Back to results

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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ibritumomab Tiuxetan (Zevalin)
Sponsored by
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Allogeneic, Lymphoma, GELTAMO, Z-RIC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Santa Creu i Sant Pau.
  • Clinica Universitaria de Navarra
  • H.U. 12 de Octubre
  • H.U. Gregorio Marañón
  • H.U. La Princesa
  • H.U. Ramón y Cajal.
  • H. Morales Meseguer.
  • H. Virgen de la Arrixaca
  • H. Central de Asturias
  • H. Clinico de Salamanca
  • H. U. Marqués de Valdecilla.
  • H. Clínico Valencia
  • H. La Fe
  • H.U. Miguel Servet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

safety (toxicity, transplantation- and graft-related mortality)
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
overall survival
relapse rate
acute and chronic Graft-versus-Host Disease
haematological and immunological reconstitution, and chimerism.
the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival

Full Information

First Posted
March 18, 2008
Last Updated
March 23, 2017
Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
search

1. Study Identification

Unique Protocol Identification Number
NCT00644371
Brief Title
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 21, 2011 (Actual)
Study Completion Date
February 4, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
Allogeneic, Lymphoma, GELTAMO, Z-RIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan (Zevalin)
Other Intervention Name(s)
Rituximab (Mabthera)
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
safety (toxicity, transplantation- and graft-related mortality)
Time Frame
36 months
Title
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
Time Frame
36 months
Title
overall survival
Time Frame
36 months
Title
relapse rate
Time Frame
36 months
Title
acute and chronic Graft-versus-Host Disease
Time Frame
36 months
Title
haematological and immunological reconstitution, and chimerism.
Time Frame
Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
Title
the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Caballero, MD
Organizational Affiliation
Hospital Clínico Universitario de Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Santa Creu i Sant Pau.
City
Barcelona
State/Province
Barcelona.
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
H.U. 12 de Octubre
City
Madrid
Country
Spain
Facility Name
H.U. Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
H.U. La Princesa
City
Madrid
Country
Spain
Facility Name
H.U. Ramón y Cajal.
City
Madrid
Country
Spain
Facility Name
H. Morales Meseguer.
City
Murcia
Country
Spain
Facility Name
H. Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
H. Central de Asturias
City
Oviedo
Country
Spain
Facility Name
H. Clinico de Salamanca
City
Salamanca
Country
Spain
Facility Name
H. U. Marqués de Valdecilla.
City
Santander
Country
Spain
Facility Name
H. Clínico Valencia
City
Valencia
Country
Spain
Facility Name
H. La Fe
City
Valencia
Country
Spain
Facility Name
H.U. Miguel Servet
City
Zaragoza.
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27771496
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs