Ofatumumab for lymphoma therapy

• Conditions: Relapsed or refractory diffuse large B cell lymphoma (DLBCL).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000933-37-GR
• Lead Sponsor: ational and Kapodostrian University of Athens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Signed and dated written informed consent prior to performing any study-specific procedures.
- Adult patients, age range 18-65 years old, eligible for transplantation. Patients > 65 and = 70 years old with ECOG =2 and absence of comorbidities will be included in the study upon investigator’s judgment.
- Histologically confirmed diagnosis of relapsed or refractory CD20 positive DLBCL. Diagnosis should be confirmed by immunophenotyping by staining paraffin embedded tissue sections with the following panel of markers: BCL2, CD5, CD10, CD3, CD4, CD8, BCL6, IRF4/MUM-1, Ki67, p53, ALK, HLA class I and HLA-DR.
- First relapse after CR or less than PR after first line treatment.
- Previous treatment with chemotherapy regimen containing anthracyclines with rituximab for at least 3 cycles.
- ECOG Performance Status 0-2.
- Life expectancy of more than 3 months.
- Adequate bone marrow, liver and renal function:
* Hemoglobin = 9.0 g/dL.
* Absolute neutrophil count (ANC) = 1500/µl.
* Platelet count = 100000/µl.
* Total bilirubin = 1.5 X ULN.
* AST and ALT = 2.5 x ULN.
* Alkaline phosphatase = 1.5 x ULN.
* Serum creatinine < 1.5 x ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Burkitt, mantle-cell and T cell Lymphoma.
- CD20 negative DLBCL.
- Central nervous system and/or bone marrow involvement.
- Prior transplantation.
- No prior treatment with anthracycline-containing regimen.
- Treatment with rituximab or treatment with rituximab for less than 3 cycles.
- Other past or current malignancy with the exception of cured (minimum 2 years prior entry) basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast.
- History of significant cerebrovascular disease or event with significant symptoms or sequelae.
- Any major organ dysfunction.
- History of HIV infection.
- Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the patient will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the patient can be included.
- Positive serology for hepatitis C (HC) defined by positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
- Previous treatment or known or suspected hypersensitivity to ofatumumab.
- Known or suspected hypersensitivity to any of the components of the ESHAP regimen.
- Treatment with any investigational drug substance or experimental therapy within 4 weeks prior to the 1st treatment cycle, or current participation in any other interventional clinical trial.
- Known or suspected inability to comply with study protocol.
- Lactating women, women with a positive pregnancy test at screening or women (of childbearing potential) as well as men with female partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last treatment dose. Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that patient. The double barrier method can be used in regions where considered acceptable and adequate (condom or occlusive cap plus spermicidal agent).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified