Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01613300
First received: June 5, 2012
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

The aim of this study is rate of acute graft-versus-host disease II-IV measured at day +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant


Condition Intervention Phase
B-Cell Lymphomas
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ofatumumab as Part of the Reduced Intensity Conditioning Regimen (RIC) for Patients With High Risk B Non Hodgkin's Lymphoma Undergoing Allogeneic Hematopoietic Cell Transplantation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of acute grade II-IV graft-versus-host disease at 1 year [ Time Frame: 5 years follow-up ] [ Designated as safety issue: Yes ]
    According to conventional criteria. This endpoint will be descriptively reported. Confidence intervals (95% bounds) will be provided. The rate will be analyzed in all patients enrolled at the clinical trial and that no major violation has been produced.


Secondary Outcome Measures:
  • To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: May 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Drug: Ofatumumab
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Other Name: ARZERRA

Detailed Description:

In addition to above:

  • Rate of progression-free survival (PFS) at 12, 24, 36 and 60 months post-transplant defined as the time between the infusion of progenitors and the disease progression or death. Patients alive or in complete remission will be censored at the time of last follow up
  • Transplant-related mortality (TRM) at 12, 24, 36 and 60 months after transplantation, defined as any death not caused directly by lymphoma (any death caused by complications related to transplantation).
  • Overall survival (OS) defined as the time between infusion of progenitors and the patient's death from any cause. Alive Patients will be censored at the time of last follow-up
  • Incidence of chronic graft versus host disease (GVHD) wide at 1 and 5 years according to conventional criteria (Atkinson et al. 1989) and Filipovich et al. (BBMT, 2005).
  • Rate of event-free survival (DFS) defined as time interval between diagnosis of lymphoma and lymphoma progression or relapse or death if the above does not occur.
  • Successful graft implantation: is defined as:

    1. º: three consecutive days with absolute neutrophil count greater than 0.5 * 109 / L
    2. ° thrombocythemia exceeds 20 * 109 / L.
  • Reconstitution of the immune system: lymphocyte count populations CD20, CD3, CD4 and CD8 and immunoglobulinemia serum (days +100, 180, 360, 18 months and 24 months).
  • intercurrent infections. All sorts of infections (viral, fungal and bacterial)will be recorded
  • Safety assessment by the standards of Common Terminology Criteria for adverse events v. 4.0
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have given their informed consent before any study-specific procedures
  2. Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes:
  3. High risk CD +20 Lymphoma having at least one of the following characteristics:

    • Less than a partial remission after two courses of treatment
    • Relapse after autologous peripheral blood stem cell (PBSCT)
    • Evidence of measurable disease (With CT and PET or PET / CT) three months after PBSCT
    • Hematopoietic precursors improper count in patients with relapsed or partial remission after two treatment lines that prevent the realization of a PBSCT.
    • Patients after first relapse in RP after two lines of treatment in whom the probability of freedom from progression per year is very low due to risk factors such as: first CR less than 12 months after PBSCT low SLP, etc..
  4. Age between 18 and 65 years
  5. ECOG between 0 to 1 (Appendix III).
  6. Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be include in the study but must undergo HBV DNA monitoring
  7. Adequate lung Function
  8. Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography.
  9. Adequate renal and hepatic function defined by the following biochemical parameters
  10. The disease status prior to transplantation had to be in place in accordance with the criteria of Revised Response Criteria for Malignant Lymphoma, Cheson 2007. CT and PET or PET / CT.
  11. Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated
  12. Adults with ability to procreate must commit to use an effective method of birth control during the study treatment and at least 6 months.

Exclusion Criteria:

  1. Refractory disease at the time of transplantation
  2. Progressive disease at the time of transplantation.
  3. ECOG≤2
  4. Lymphoma associated with infection with human immunodeficiency virus (HIV).
  5. Test positive for HIV.
  6. Presence of anti-murine antibodies (HAMA) or (HACA).
  7. Treatment with any marketed or experimental drug administered not in a period between 5 terminal half-lives of clearance of therapy or 4 weeks before enrollment
  8. Participation in another interventional clinical trial.
  9. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy. This is generally required and may be excluded as applicable.
  10. Hepatitis B positive serology
  11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
  12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
  13. Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis, metastases).
  14. Other past or current malignancy.
  15. Chronic infectious disease that requires ongoing treatment with systemic antibiotics, antifungal or antiviral drugs
  16. History of cerebrovascular disease active in the last 6 months or event with significant symptoms or sequelae.
  17. Clinically significant heart disease, such as unstable angina, acute myocardial infarction in the six months prior to inclusion, congestive heart failure (grades III-IV NYHA) and arrhythmia unless it is controlled by treatment, except for premature or disorders Mild driving.
  18. Concurrent medical disorder, uncontrolled and important, such as kidney disease, liver, digestive, endocrine, pulmonary, neurological, brain, psychiatric, or which in the opinion of the investigator may represent a risk to the patient
  19. Pregnancy or breastfeeding
  20. Women of childbearing potential, including those whose last menstrual period was one year prior to screening.
  21. Men unable or unwilling to use contraception
  22. Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus, sirolimus and / or any excipients.
  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: NCT01613300

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

Locations
Spain
ICO-Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08918
Contact: Christelle Ferrá       cferra@iconcologia.net   
Principal Investigator: Christelle Ferrá, MD         
ICO-Hospital Durans i Reynals Withdrawn
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Carmen Martinez       cmarti@clinic.ub.es   
Principal Investigator: Carmen Martinez, MD         
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Javier Briones       jbriones@santpau.cat   
Principal Investigator: Javier Briones, MD         
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Contact: David Valcárcel    David    dvalcarcel.vhebron@me.com   
Principal Investigator: David Valcárcel, MD         
Hospital Reina Sofia Recruiting
Córdoba, Spain
Contact: Mª del Carmen Martín       carmen.martin.calvo.sspa@juntadeandalucia.es   
Principal Investigator: Mª del Carmen Martín, MD         
H.U. 12 de Octubre, Recruiting
Madrid, Spain
Contact: Carlos Grande, MD       carlos.grande@salud.madrid.org   
Principal Investigator: Carlos Grande, MD         
H.U. Gregorio Marañón, Recruiting
Madrid, Spain
Contact: Jorge Gayoso, MD       jgayoso.hgugm@salud.madrid.org   
Principal Investigator: Jorge Gayoso, MD         
H.U. La Paz Recruiting
Madrid, Spain
Contact: Miguel Ángel Canales       mcanales.hulp@salud.madrid.org   
Principal Investigator: Miguel Ángel Canales, MD         
H. Morales Meseguer. Recruiting
Murcia, Spain
Contact: Inmaculada Heras, MD       inmheras@um.es   
Principal Investigator: Inmaculada Heras, MD         
Complejo Hospitalario Carlos Haya Recruiting
Málaga, Spain, 29010
Contact: Mª Jesús Pascual       mariaj.pascual.sspa@juntadeandalucia.es   
Principal Investigator: Mª Jesús Pascual, MD         
Hospital Son Espasses Recruiting
Palma de Mallorca, Spain
Contact: Antonio Gutiérrez, MD       antoniom.gutierrez@ssib.es   
Contact       antoniom.gutierrez@ssib.es   
Principal Investigator: Antonio Gutierrez, MD         
H. Clinico de Salamanca Recruiting
Salamanca, Spain
Contact: Lucia López, MD       lucialopezcorral@usal.es   
Principal Investigator: Lucia López, MD         
Hospital Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Rocio Parody       rparodyp@yahoo.es   
Principal Investigator: Rocio Parody, MD         
H. La Fe Recruiting
Valencia, Spain
Contact: Isidro Jarque, MD       jarque_isi@gva.es   
Principal Investigator: Isidro Jarque, MD         
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
Principal Investigator: Maria Dolores Caballero, MD Hospital Clinico de Salamanca
  More Information

No publications provided

Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01613300     History of Changes
Other Study ID Numbers: GELTAMO-O-CRT-2011, 2011-004729-29
Study First Received: June 5, 2012
Last Updated: April 20, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
hodgkin
disease
ofatumumab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 31, 2015