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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 77 NHL

News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms

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News

HO77 news

10 JUN 2010: Nieuwe versie CRFs staan op de website: versie 01 JUN 2010

Graag vanaf dit moment alleen deze nieuwe versie gebruiken voor alle patienten.

1 JUN 2010: De HOVON 77 studie is gesloten voor inclusie.

De interim analyse (tevens eindanalyse) zal eind 2010 plaatsvinden.

4 FEB 2010: De HOVON 77 studie is nog steeds open !
Tijdens de HOVON meeting najaar 2009 is gemeld dat de HOVON 77 NHL studie eind december gesloten zou worden. Besloten is echter de studie open te houden tot de 20e patient is geincludeerd. Momenteel staat de teller op 18. Alle deelnemers zullen worden geinformeerd, wanneer de sluitingsdatum bekend is.

1. Overview

Summary

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)

Status

closed

Type of study

Prospective Phase II study

Type of monitoring for this study

Site evaluation visits

Target number of patients

Date of activation

12-May-2006

Date closed

01-Jun-2010

Approved by

EudraCTnr.: 2005-003796-20
CKTO: March 30, 2006
MEC: METC VUMC 2005/222, January 31, 2006

Study objectives

Evaluation of efficacy and safety of 90Y-ibritumomab tiuxetan

2. Patient eligibility criteria

Inclusion criteria

Age > 60 years old
WHO performance status of 0-2 (see Appendix E of protocol)
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 of protocol)
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 109/l
Hemoglobin (Hb)> 6 mmol/l
Platelets > 150 x 109/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 R-CHOP 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 non-melanoma 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

3. Registration (& randomization) of patients

Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top

Registration criteria

The following information will be requested:

Protocol number
Institution name
Name of caller/responsible investigator
Patient initials or code
Patient hospital record number (optional)
Sex
Date of birth
Eligibility criteria

4. Participating parties

Principal investigator

J.M. Zijlstra (j.zijlstra@vumc.nl)

Coordinating investigator(s)

Prof. Dr. A. Hagenbeek (a.hagenbeek@amc.uva.nl)
O.S. Hoekstra (os.hoekstra@vumc.nl)

Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)

Trial manager

C.M.C. van Hooije (c.vanhooije@erasmusmc.nl)

Central data management