Main info

Identificatie:

HO77 NHL

Sponsor:

HOVON

Working group party:

Lymphoma

Age:

>= 60

Stadium:

1st lijn

Included patients:

19

(of 19)

Active sites:

32

(of 24)

Title:

Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg) 90Y-ibritumomab tiuxetan ('Zevalin') in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77)

Timeline

News

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Not any more

Objectives:

Primary objective
The primary objective of this study is to evaluate the conversion rate from PET-positive to PETnegative residual masses after 90Y-ibritumomab tiuxetan treatment in patients with PET-positive partial remission following first-line R-CHOP chemotherapy.

Secondary objectives
To evaluate the progression-free survival, the overall survival (OS) and the toxicity of DLBCLpatients with PET-positive partial remission treated with 90Y-ibritumomab tiuxetan.

Eligibility

Inclusion Criteria:

• Age ≥ 60 years old
• WHO performance status of 0-2 (see Appendix E)
• Life expectancy of at least 3 months
• Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification (see Appendix B)
• First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed)
• Partial response on CT-scans after first-line treatment, with measurable disease
• PET-positive residual mass
• Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation
• Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy)
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l
• Hemoglobin (Hb) ≥ 6 mmol/l
• Platelets ≥ 150 x 10^9/l
• Written informed consent obtained according to local guidelines

Exclusion Criteria:

• Hypoplastic bone marrow at biopsy
• Prolonged pancytopenia during induction chemotherapy and delayed courses during RCHOP induction (more than two weeks delay due to insufficient bone marrow reserve)
• Known hypersensitivity to murine antibodies or proteins
• Significant splenomegaly
• Patients with abnormal liver function (total bilirubin > 2.0 x ULN)
• Patients with abnormal renal function (serum creatinine > 2.0 x ULN)
• Presence of CNS involvement by NHL
• Presence of any other active neoplasms or history of prior malignancy, except nonmelanoma skin tumours or stage 0 (in situ) cervical carcinoma during the past 5 years
• More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL
• Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)
• Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
• Patients who have received biologic therapy, immunotherapy, R-CHOP(-like) chemotherapy, surgery, or an investigational drugs less than 4 weeks prior to first day of study treatment or who have not recovered from the toxic effects of such therapy
• Patients who have received systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent less than 2 weeks prior to 90Y-ibritumomab tiuxetan administration
• Known diagnosis of HIV infection
• Patients unwilling or unable to comply with the protocol

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals