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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT00644371
First received: March 18, 2008
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Non-Hodgkin Lymphoma Drug: Ibritumomab Tiuxetan (Zevalin) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 12 months ]

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

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: February 4, 2013
Primary Completion Date: February 21, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ibritumomab Tiuxetan (Zevalin)

Conditioning Regimen

  1. Rituximab, 250 mg/m2 on days -21 and -14.
  2. 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.
Other Name: Rituximab (Mabthera)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00644371

Locations
Spain
H. Santa Creu i Sant Pau.
Barcelona, Barcelona., Spain
Clinica Universitaria de Navarra
Pamplona, Navarra, 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
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., Spain
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
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: NCT00644371     History of Changes
Other Study ID Numbers: GELTAMO-Z-RIC-Allo
EuDRACT nº:2007-003302-10
Study First Received: March 18, 2008
Last Updated: March 23, 2017

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Rituximab
Melphalan
Thiotepa
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 August 23, 2017