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B-Cell LymphomasPhase 2NCT01613300

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

A Phase 2 study testing Ofatumumab in people with B-Cell Lymphomas, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 10 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
B-Cell Lymphomas
What is being tested?
Ofatumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
10 sitesSpain
Study dates
4 Apr 2012to Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have given their informed consent before any study-specific procedures
  • Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes:
  • 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
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  • 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..
  • Age between 18 and 65 years
  • ECOG between 0 to 1 (Appendix III).
  • Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be include in the study but must undergo HBV DNA monitoring
  • Adequate lung Function
  • Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography.
  • Adequate renal and hepatic function defined by the following biochemical parameters
  • 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.
  • Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated
  • Adults with ability to procreate must commit to use an effective method of birth control during the study treatment and at least 6 months.

Who cannot join

  • Refractory disease at the time of transplantation
  • Progressive disease at the time of transplantation.
  • ECOG≤2
  • Lymphoma associated with infection with human immunodeficiency virus (HIV).
  • Test positive for HIV.
  • Presence of anti-murine antibodies (HAMA) or (HACA).
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  • 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
  • Participation in another interventional clinical trial.
  • 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.
  • Hepatitis B positive serology
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
  • Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
  • Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis, metastases).
  • Other past or current malignancy.
  • Chronic infectious disease that requires ongoing treatment with systemic antibiotics, antifungal or antiviral drugs
  • History of cerebrovascular disease active in the last 6 months or event with significant symptoms or sequelae.
  • 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.
  • 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
  • Pregnancy or breastfeeding
  • Women of childbearing potential, including those whose last menstrual period was one year prior to screening.
  • Men unable or unwilling to use contraception
  • Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus, sirolimus and / or any excipients.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital Reina Sofia

    Córdoba

  • H.U. 12 de Octubre,

    Madrid

  • H.U. Gregorio Marañón,

    Madrid

  • H.U. La Paz

    Madrid

  • Complejo Hospitalario Carlos Haya

    Málaga, 29010

  • H. Morales Meseguer.

    Murcia

  • H. Clinico de Salamanca

    Salamanca

  • Hospital Virgen del Rocío

    Seville, 41013

  • H. La Fe

    Valencia

Other trials in Spain

About this study

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

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
Being tested
Ofatumumab
Keywords
hodgkin, disease, ofatumumab
Medical subject headings
Lymphoma, B-Cell, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    Also called ARZERRA

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

Study groups in NCT01613300
Study groupRoleWhat they receive
OfatumumabExperimentalOfatumumab as part of the reduced intensity conditioning regimen (RIC)
Receives: Drug: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years follow-up

Secondary outcomes (1)

  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

    Measured: 5 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2012 (estimated)
  2. Study start4 Apr 2012
  3. Primary completionJun 2016
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01613300
Sponsor's protocol ID
GELTAMO-O-CRT-2011
Other IDs
2011-004729-29
Status last verified
Jan 2021
First submitted
5 Jun 2012
Last updated
26 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cabrero M, Lopez-Corral L, Jarque I, de la Cruz-Vicente F, Perez-Lopez E, Valcarcel D, Sanz J, Espigado I, Orti G, Martin-Calvo C, de la Serna J, Caballero D; Grupo Espanol de Trasplante Hematopoyetico (GETH) and Grupo Espanol de Linfomas y Trasplante Autologo (GELTAMO). Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial. Bone Marrow Transplant. 2024 Mar;59(3):359-365. doi: 10.1038/s41409-023-02171-5. Epub 2024 Jan 2.

    PubMed 38167647

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab in people with B-Cell Lymphomas, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of acute grade II-IV graft-versus-host disease at 1 year (time frame: 5 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01613300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.

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