ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-Cell Difusse Lymphom (Z-BEAM LDGGB)

This study is currently recruiting participants.
Verified by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, March 2008

Sponsored by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT00646750
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
Phase II

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Etoposide    Melphalan    Rituximab    Etoposide phosphate    Ibritumomab tiuxetan    Melphalan hydrochloride    Sarcolysin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-Cell Diffuse Lymphom

Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Overall response rate (complete + partial response) [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • Progression-free-survival [ Time Frame: 36 month ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 96 months ] [ Designated as safety issue: No ]
  • Post-transplantation haematological and immunological reconstitution [ Time Frame: Until post-transplantation day +100 ] [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   January 2008

Arms Assigned Interventions
1: Experimental
BEAM preceded by Ybritumomab Tiuxetan (Zevalin)
Drug: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)

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.


  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646750

Contacts
Contact: Dolores Caballero, MD     +34618834923     cabarri@usal.es    
Contact: Ana M Mendez     +34942203450     geltamo@humv.es    

Locations
Spain
Hospital Universitario de Alicante     Recruiting
      Alicante, Spain
      Contact: Pascual Fernández, MD            
H. de la Santa Creu i Sant Pau     Recruiting
      Barcelona, Spain
      Contact: Javier Briones, MD            
Instituto Catalán de Oncología,     Recruiting
      Barcelona, Spain
      Contact: Eva González, MD            
H. Reina Sofía     Recruiting
      Córdoba, Spain
      Contact: Antonio Torres, MD            
H.U. La Paz     Recruiting
      Madrid, Spain
      Contact: Miguel Canales, MD            
H.U. Gregorio Marañón,     Recruiting
      Madrid, Spain
      Contact: Jorge Gayoso, MD            
Clínica Puerta de Hierro,     Recruiting
      Madrid, Spain
      Contact: José Antonio García-Marco, MD            
H.U. La Princesa     Recruiting
      Madrid, Spain
      Contact: Reyes Arranz, MD            
M.D. Anderson Internacional     Recruiting
      Madrid, Spain
      Contact: José Francisco Tomás, MD            
H.U. 12 de Octubre,     Recruiting
      Madrid, Spain
      Contact: Carlos Grande, MD            
H.U. Virgen de la Arrixaca     Recruiting
      Murcia, Spain
      Contact: José M Moraleda, MD            
H. Morales Messeguer     Recruiting
      Murcia, Spain
      Contact: Inmaculada Heras, MD            
H. Clínico Universitario de Salamanca     Recruiting
      Salamanca, Spain
      Contact: Dolores Caballero, MD            
      Principal Investigator: Caballero, MD            
H.U. Marqués de Valdecilla     Recruiting
      Santander, Spain
      Contact: Eulogio Conde, MD            
H.U. La Fe     Recruiting
      Valencia, Spain
      Contact: Isidro Jarque, MD            
Spain, Asturias
H.U. Central de Asturias, Oviedo     Recruiting
      Oviedo, Asturias, Spain
      Contact: Teresa Bernal del Castillo, MD            
Spain, Canarias
H.Universitario de Canarias     Recruiting
      Santa Cruz de Tenerife, Canarias, Spain
      Contact: Miguel Hernández, MD            
Spain, Navarra
Clínica Universitaria de Navarra     Recruiting
      Pamplona, Navarra, Spain
      Contact: Carlos Panizo, MD            

Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators
Principal Investigator:     Javier Briones, MD     Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau    
Principal Investigator:     Dolores Caballero, MD     Hospital Clínico Universitario de Salamanca    
  More Information


Responsible Party:   Hospital de la Santa Creu i Sant Pau, Servicio de Hematología ( Dr. Javier Briones )
Study ID Numbers:   GELTAMO-Z-BEAM LDGGB, EudraCT No.: 2007-003198 - 22
First Received:   March 17, 2008
Last Updated:   March 25, 2008
ClinicalTrials.gov Identifier:   NCT00646750
Health Authority:   Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Z-BEAM  
Autologous  
Lymphoma  
GELTAMO  

Study placed in the following topic categories:
Melphalan
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Etoposide phosphate
Etoposide
Lymphoma
Cytarabine

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 14, 2008




Links to all studies - primarily for crawlers