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Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom (Z-BEAM LDGGB)

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
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's Lymphoma focused on measuring Z-BEAM, Autologous, Lymphoma, GELTAMO

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Give their written informed consent.

  2. Abide by at least one of the following conditions:

    • Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
    • Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
    • Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
    • Patients with transformed lymphoma, on first partial remission (No CR).
  3. Stable disease at the time of transplantation.
  4. Age ≥ 18 but ≤ 70.
  5. Life expectancy of greater than three months.

Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:

  1. Performance status (ECOG) < 3.
  2. FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
  3. Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
  4. Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease.
  5. Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease.
  6. Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
  7. HIV negative.

Exclusion Criteria:

  1. Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
  2. Known hypersensitivity to mouse proteins.
  3. Involvement of CNS by lymphoma.
  4. Progressive lymphoma during the month prior to the date of transplantation.
  5. Previous radioimmunotherapy.
  6. Previous autologous transplantation of haematopoietic stem cells.
  7. Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
  8. Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
  9. Active psychiatric disease, including addiction disorders.
  10. Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.

Sites / Locations

  • H.U. Central de Asturias, Oviedo
  • H.Universitario de Canarias
  • Clínica Universitaria de Navarra
  • Hospital Universitario de Alicante
  • H. de la Santa Creu i Sant Pau
  • Instituto Catalán de Oncología,
  • H. Reina Sofía
  • Clínica Puerta de Hierro,
  • H.U. 12 de Octubre,
  • H.U. Gregorio Marañón,
  • H.U. La Paz
  • H.U. La Princesa
  • M.D. Anderson Internacional
  • H. Morales Messeguer
  • H.U. Virgen de la Arrixaca
  • H. Clínico Universitario de Salamanca
  • H.U. Marqués de Valdecilla
  • H.U. La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

BEAM preceded by Ybritumomab Tiuxetan (Zevalin)

Outcomes

Primary Outcome Measures

Disease clinical response to treatment - complete response rate.

Secondary Outcome Measures

Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
Overall response rate (complete + partial response)
Progression-free-survival
Overall survival
Post-transplantation haematological and immunological reconstitution

Full Information

First Posted
March 17, 2008
Last Updated
February 12, 2016
Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT00646750
Brief Title
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom
Acronym
Z-BEAM LDGGB
Official Title
Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2012 (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 efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Z-BEAM, Autologous, Lymphoma, GELTAMO

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
BEAM preceded by Ybritumomab Tiuxetan (Zevalin)
Intervention Type
Drug
Intervention Name(s)
Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
Other Intervention Name(s)
Ybritumomab Tiuxetan (Zevalin), Rituximab (Mabthera)
Intervention Description
Day -21: rituximab. 250 mg/m2 iv Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi). Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.
Primary Outcome Measure Information:
Title
Disease clinical response to treatment - complete response rate.
Time Frame
Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
Secondary Outcome Measure Information:
Title
Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.
Time Frame
36 months
Title
Overall response rate (complete + partial response)
Time Frame
36 month
Title
Progression-free-survival
Time Frame
36 month
Title
Overall survival
Time Frame
96 months
Title
Post-transplantation haematological and immunological reconstitution
Time Frame
Until post-transplantation day +100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Give their written informed consent. Abide by at least one of the following conditions: Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like. Patients on first recidivation who do not attain partial remission after salvage chemotherapy. Patients with transformed lymphoma, on first partial remission (No CR). Stable disease at the time of transplantation. Age ≥ 18 but ≤ 70. Life expectancy of greater than three months. Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.: Performance status (ECOG) < 3. FEV1, DLCO and FVC ≥ 50% of the normal theoretical values. Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%. Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease. Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease. Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis. HIV negative. Exclusion Criteria: Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg. Known hypersensitivity to mouse proteins. Involvement of CNS by lymphoma. Progressive lymphoma during the month prior to the date of transplantation. Previous radioimmunotherapy. Previous autologous transplantation of haematopoietic stem cells. Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method. Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial. Active psychiatric disease, including addiction disorders. Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Briones, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
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.U. Central de Asturias, Oviedo
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
H.Universitario de Canarias
City
Santa Cruz de Tenerife
State/Province
Canarias
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Hospital Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
H. de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Instituto Catalán de Oncología,
City
Barcelona
Country
Spain
Facility Name
H. Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Clínica Puerta de Hierro,
City
Madrid
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 Paz
City
Madrid
Country
Spain
Facility Name
H.U. La Princesa
City
Madrid
Country
Spain
Facility Name
M.D. Anderson Internacional
City
Madrid
Country
Spain
Facility Name
H. Morales Messeguer
City
Murcia
Country
Spain
Facility Name
H.U. Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
H. Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
H.U. Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
H.U. La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom

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