Ensayo clinico multicentrico, abierto, de un solo brazo, y de fase 2, con ofatumumab en pacientes con linfoma de celulas B grandes difuso (LCBGD) en recidiva no elegibles para trasplante o en recidiva tras trasplante autologoAn open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Conditions: infoma de células B grandes difusoDiffuse Large B-Cell Lymphoma
MedDRA version: 9.1Level: LLTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrent

Registration Number: EUCTR2007-004190-26-ES

Lead Sponsor: Genmab A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1. Patients with relapsed DLBCL and ineligible for stem cell transplantation or relapsed DLBCL after autologous stem cell transplantation
2. Tumor verified to be CD20+ positive from excisional or incisional lymph node biopsy.
3. CT scan in screening phase (based on local evaluation) showing:
a. 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
b. 1 clearly demarcated lesion with a largest diameter = 2.0 cm
4. ECOG Performance Status of 0, 1, or 2
5. Age = 18 years
6. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than 1 previous radioimmunotherapy regimen
2. Received radioimmunotherapy within 3 months prior to Visit 2
3. Received any of the following treatments within 4 weeks prior to Visit 2:
a. Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)
b. Glucocorticoid unless given in doses equivalent to = 10 mg of prednisolone /day
4. Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 2
5. Patients previously treated with other anti-CD20 monoclonal antibodies than rituximab, tositumomab and ibritumomab tiuxetan (the latter two in accordance with exclusion criteria no.1 and 2)
6. Patients with previously diagnosed and treated indolent lymphoma
7. Known CNS involvement of DLBCL
8. Past or current malignancy, except for:
a. Cervical carcinoma Stage 1B or less
b. Non-invasive basal cell and/or squamous cell skin carcinoma
c. Malignant melanoma with a complete response of a duration of < 10 years
d. Other cancer diagnoses with a complete response of a duration of < 5 years
9. Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
10. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure (NYHA III-IV), and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
11. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
12. History of significant cerebrovascular disease
13. Known HIV positive
14. Positive serology for hepatitis B (HB) defined as:
a. Positive test for HBsAg and/or
b. Positive test for anti-HBs and anti-HBc
Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will not be considered positive.

15. Screening laboratory values:
a. platelets < 50 x 10^9/L (unless due to DLBCL involvement of the bone marrow)
b. neutrophils < 1.0 x 10^9/L (unless due to DLBCL involvement of the bone marrow)
c. creatinine > 2.0 times upper normal limit (unless normal creatinine clearance)
d. total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of DLBCL)
e. ALT > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)
f. alkaline phosphatase > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)
16. Known or suspected hypersensitivity to components of investigational product
17. Life expectancy less than 6 months
18. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2
19. Current participation in any other interventional clinical trial
20. Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
21. Breast feeding women or women with a positive pregnancy test at Visit 1
22. Women of childbearing potential not willing to use adequate contraception during trial and one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant;Secondary Objective: To determine the safety and pharmacokinetic (PK) profile of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant;Primary end point(s): Objective response as measured over a 6 month period from start of treatment with ofatumumab assessed according to the Revised response criteria for malignant lymphoma

Secondary Outcome Measures