Full title of the trial : An open-label, multicentre, dose-escalating phase I/II trial of 3-weekly rhuMAb 2H7 in patients with follicular non Hodgkin’s lymphoma - N/A

• Conditions: follicular non-Hodgkin’s lymphoma (NHL)

• Registration Number: EUCTR2004-004110-17-SE
• Lead Sponsor: Roche Products Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Able and willing to provide written informed consent and to comply with the study protocol.
2. Age > or equal to18 years.
3. History of histologically confirmed CD20+, follicular NHL (any grade) according to the WHO classification system (WHO 2002; Appendix 2D).
4. Histopathology will be reviewed at the study site to confirm diagnosis. CD20 expression will be assessed at the study site according to local standard procedures.
5. Documented history of a response (CR/CRu/PR >6 months) or SD of >6 months duration to a prior rituximab-containing regimen that was the last treatment given prior to enrolment.
There is no limit to the number of prior chemotherapy or rituximab regimens. Patients may be refractory to prior chemotherapy but must have responded to the last rituximab containing regimen as defined above.
6. At least one bidimensionally measurable lesion (> or = to 1.5 cm in its largest dimension by computerized tomography [CT] scan). Note that all measurable and evaluable disease must be assessed and documented prior to initiation of treatment. Tumor response will be based on the status of all areas of disease.
7. ECOG performance status of 0 or 1.
8. Life expectancy > or = to 6 months.
9. No evidence of acute or chronic hepatitis B virus [HBV] or hepatitis C virus [HCV] infection

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior use of any monoclonal antibody therapy other than rituximab, or any anti-cancer vaccine, or any radioimmunotherapy for cancer.
2. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products.
3. Central nervous system lymphoma or histological evidence of transformation to high grade or diffuse large B-cell lymphoma.
4. History of malignancy other than follicular NHL which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible.
5. Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm).
6. Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
7. Recent major surgery (within 4 weeks prior to screening), other than for diagnosis.
8. Any of the following abnormal laboratory values:
•Serum creatinine > 2 mg/dL.
•Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal.
•Platelet count <75 x 10exp 9/L.
•Neutrophils <1.5 x 10exp9/L.
9. Pregnancy or lactation.
10. Fertile men or women of childbearing potential unless (1) surgically sterile or (2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly. Effective contraception is required throughout the study and (because of the long half-life of humanized monoclonal antibodies and the potential for prolonged lymphopenia) for at least 12 months after the last dose of rhuMAb 2H7.
11. Treatment within a clinical study within 30 days prior to trial entry.

Study & Design

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