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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613300
Recruitment Status : Active, not recruiting
First Posted : June 7, 2012
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Brief Summary:
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 or disease Intervention/treatment Phase
B-Cell Lymphomas Drug: Ofatumumab Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Primary Completion Date : June 2016
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ofatumumab
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of acute grade II-IV graft-versus-host disease at 1 year [ Time Frame: 5 years follow-up ]
    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 :
  1. To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary [ Time Frame: 5 years follow up ]
    To analyze the complete response rate after treatment

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613300

Hospital Vall d'Hebron
Barcelona, Spain
Hospital Reina Sofia
Córdoba, Spain
H.U. 12 de Octubre,
Madrid, Spain
H.U. Gregorio Marañón,
Madrid, Spain
H.U. La Paz
Madrid, Spain
H. Morales Meseguer.
Murcia, Spain
Complejo Hospitalario Carlos Haya
Málaga, Spain, 29010
H. Clinico de Salamanca
Salamanca, Spain
Hospital Virgen del Rocío
Sevilla, Spain, 41013
H. La Fe
Valencia, Spain
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Principal Investigator: Maria Dolores Caballero, MD Hospital Clinico de Salamanca

Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Identifier: NCT01613300     History of Changes
Other Study ID Numbers: GELTAMO-O-CRT-2011
2011-004729-29 ( EudraCT Number )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs