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CompletedNCT01613300Updated May 26, 2021

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

A Phase 2 interventional study of Ofatumumab in B-Cell Lymphomas, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Completed at 10 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • B-Cell Lymphomas

Keywords

  • hodgkin
  • disease
  • ofatumumab
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 33 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Ofatumumab

    Ofatumumab as part of the reduced intensity conditioning regimen (RIC)

    Drug: Ofatumumab

Interventions

  • DrugOfatumumab

    Ofatumumab as part of the reduced intensity conditioning regimen (RIC)

    Also known as: ARZERRA

06

What researchers measure

Primary outcomes

  1. Rate of acute grade II-IV graft-versus-host disease at 1 year

    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.

    Time frame: 5 years follow-up

Secondary outcomes

  1. To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary

    To analyze the complete response rate after treatment

    Time frame: 5 years follow up

07

Study locations

10 sites
  • 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, 29010, Spain
  • H. Clinico de Salamanca
    Salamanca, Spain
  • Hospital Virgen del Rocío
    Sevilla, 41013, Spain
  • H. La Fe
    Valencia, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01613300
Lead sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Responsible party
Sponsor
First posted
Jun 7, 2012
Start date
Apr 4, 2012
Primary completion
Jun 2016
Completion
Jun 2020
Last update
May 26, 2021

Study contacts

Maria Dolores Caballero, MD
principal investigator · Hospital Clinico de Salamanca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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