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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT00644371
First received: March 18, 2008
Last updated: March 27, 2008
Last verified: March 2008
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety (toxicity, transplantation- and graft-related mortality) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007). [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • relapse rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • acute and chronic Graft-versus-Host Disease [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • haematological and immunological reconstitution, and chimerism. [ Time Frame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100. ] [ Designated as safety issue: No ]
  • the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Primary Completion Date: September 2009 (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 Names:
  • Ibritumomab Tiuxetan (Zevalin)
  • Rituximab (Mabthera)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Contacts
Contact: Dolores Caballero, MD cabarri@usal.es

Locations
Spain
H. Santa Creu i Sant Pau. Recruiting
Barcelona, Barcelona., Spain
Contact: Javier Briones, MD         
Clinica Universitaria de Navarra Recruiting
Pamplona, Navarra, Spain
Contact: José Rifón, MD         
H.U. La Princesa Recruiting
Madrid, Spain
Contact: Reyes Arranz, MD         
H.U. Gregorio Marañón Recruiting
Madrid, Spain
Contact: Jorge Gayoso, MD         
H.U. Ramón y Cajal. Recruiting
Madrid, Spain
Contact: Jaime Perez de Oteyza, MD         
H.U. 12 de Octubre Recruiting
Madrid, Spain
Contact: Carlos Grande, MD         
H. Virgen de la Arrixaca Recruiting
Murcia, Spain
Contact: Jose Moraleda, MD         
H. Morales Meseguer. Recruiting
Murcia, Spain
Contact: Inmaculada Heras, MD         
H. Central de Asturias Recruiting
Oviedo, Spain
Contact: Teresa Bernal, MD         
H. Clinico de Salamanca Recruiting
Salamanca, Spain
Contact: Dolores Caballero, MD       cabarri@usal.es   
H. U. Marqués de Valdecilla. Recruiting
Santander, Spain
Contact: Eulogio Conde, MD         
H. Clínico Valencia Recruiting
Valencia, Spain
Contact: Carlos Solano, MD         
H. La Fe Recruiting
Valencia, Spain
Contact: Isidro Jarque, MD         
H.U. Miguel Servet Recruiting
Zaragoza., Spain
Contact: Pilar Giraldo, MD         
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

No publications provided

Responsible Party: Dra. Dolores Caballero, GELTAMO
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 27, 2008
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014