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

March 23, 2017 updated by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • H.U. 12 de Octubre
      • Madrid, Spain
        • H.U. Gregorio Maranon
      • Madrid, Spain
        • H.U. La Princesa
      • Madrid, Spain
        • H.U. Ramón y Cajal.
      • Murcia, Spain
        • H. Virgen de la Arrixaca
      • Murcia, Spain
        • H. Morales Meseguer.
      • Oviedo, Spain
        • H. Central de Asturias
      • Salamanca, Spain
        • H. Clínico de Salamanca
      • Santander, Spain
        • H. U. Marqués de Valdecilla.
      • Valencia, Spain
        • H. Clínico Valencia
      • Valencia, Spain
        • H. La Fe
      • Zaragoza., Spain
        • H.U. Miguel Servet
    • Barcelona.
      • Barcelona, Barcelona., Spain
        • H. Santa Creu i Sant Pau.
    • Navarra
      • Pamplona, Navarra, Spain
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Rituximab (Mabthera)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
safety (toxicity, transplantation- and graft-related mortality)
Time Frame: 36 months
36 months
response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).
Time Frame: 36 months
36 months
overall survival
Time Frame: 36 months
36 months
relapse rate
Time Frame: 36 months
36 months
acute and chronic Graft-versus-Host Disease
Time Frame: 36 months
36 months
haematological and immunological reconstitution, and chimerism.
Time Frame: Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Principal Investigator: Dolores Caballero, MD, Hospital Clinico Universitario de Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 21, 2011

Study Completion (Actual)

February 4, 2013

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GELTAMO-Z-RIC-Allo
  • EuDRACT nº:2007-003302-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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