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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT00646750
First received: March 17, 2008
Last updated: February 12, 2016
Last verified: February 2016
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom

Resource links provided by NLM:


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 ]

Enrollment: 31
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Other Names:
  • Ybritumomab Tiuxetan (Zevalin)
  • Rituximab (Mabthera)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
H.U. Central de Asturias, Oviedo
Oviedo, Asturias, Spain
H.Universitario de Canarias
Santa Cruz de Tenerife, Canarias, Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain
Hospital Universitario de Alicante
Alicante, Spain
H. de la Santa Creu i Sant Pau
Barcelona, Spain
Instituto Catalán de Oncología,
Barcelona, Spain
H. Reina Sofía
Córdoba, Spain
Clínica Puerta de Hierro,
Madrid, Spain
H.U. 12 de Octubre,
Madrid, Spain
H.U. Gregorio Marañón,
Madrid, Spain
H.U. La Paz
Madrid, Spain
H.U. La Princesa
Madrid, Spain
M.D. Anderson Internacional
Madrid, Spain
H. Morales Messeguer
Murcia, Spain
H.U. Virgen de la Arrixaca
Murcia, Spain
H. Clínico Universitario de Salamanca
Salamanca, Spain
H.U. Marqués de Valdecilla
Santander, Spain
H.U. La Fe
Valencia, Spain
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: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT00646750     History of Changes
Other Study ID Numbers: GELTAMO-Z-BEAM LDGGB  EudraCT No.: 2007-003198 - 22 
Study First Received: March 17, 2008
Last Updated: February 12, 2016
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Melphalan
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on December 06, 2016