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

NCT01613300 | Completed Phase 2

• 2 other identifiers: GELTAMO-O-CRT-20112011-004729-29
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 10

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

Conditions

B-Cell Lymphomas

Keywords

hodgkin; disease; ofatumumab

Outcome Measures

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.

  5 years follow-up

Secondary Outcomes (1)

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

  5 years follow up

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

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

Also known as: ARZERRA

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (10)

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

H.U. 12 de Octubre,

Madrid, Spain

Location

H.U. Gregorio Marañón,

Madrid, Spain

Location

H.U. La Paz

Madrid, Spain

Location

Complejo Hospitalario Carlos Haya

Málaga, 29010, Spain

Location

H. Morales Meseguer.

Murcia, Spain

Location

H. Clinico de Salamanca

Salamanca, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

H. La Fe

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 38167647 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Disease

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Dolores Caballero, MD

  Hospital Clinico de Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: April 4, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)