Corona Virus

 

 

COVID-19

 

Wat betreft HOVON:

Het HOVON Data Center (HDC) en dus ook de HOVON Safety desk blijft onveranderd operationeel om de veiligheid van de patiënten in een HOVON studie te waarborgen.

De levering van studiemedicatie wordt nauwlettend opgevolgd en indien nodig zal tijdig hierover bericht worden.

Centrale lab faciliteiten zijn onveranderd operationeel. Vooralsnog is het mogelijk om patiënten in de HOVON studies te includeren.

 

Wat betreft deelnemende site:

Indien jullie nav COVID-19 situatie de inclusie voor een studie tijdelijk stopzetten graag het HDC per email hierover informeren (mail naar hdc@erasmusmc.nl).

Verder, indien er per protocol bepaalde studie visites/handelingen niet (kunnen) plaatsvinden nav COVID-19 situatie graag documenteren in de patiënten file.

 

Contact: 

Gegeven de situatie rondom Corona virus zijn het HOVON Centraal Bureau (HCB) en het HOVON Data Center (HDC) tijdelijk telefonisch niet bereikbaar.

Graag alle (urgente) vragen via email, deze zullen zsm door het team opgepakt en verwerkt worden. Wij hopen op jullie begrip voor deze situatie.

Voor studie specifieke vragen kun je contact opnemen met de trial manager van de studie of via het algemene HDC email adres (hdc@erasmucmc.nl – voeg HOVON studie nr toe).

 

 

Met vriendelijke groet, Marleen Breems (HOVON General Director) en Bianca Backx (manager HDC)


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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 144 PREBEN


News
1. Overview
Study details
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


No news


1. Overview



Summary

This is a Phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with etoposide, bendamustine (PEBEN) and for CD20 positive B-cell lymphomas, rituximab (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.


Status

open


Members

Nordic Lymphoma Group (sponsor), HOVON, Portugal, Italy, Denmark, Norway, Finland, Sweden


Study details



Type of study

Prospective Phase I/II study


Echelon level

Level D


Type of monitoring for this study

Site evaluation visits


Target number of patients

35


Study objectives

Phase I

Primary objective

• MTD of pixantrone, bendamustine and etoposide in ‘fit’ relapsed aNHL patients

Secondary objectives

• Complete response rate (CRR)
• Duration of response (DOR)

Phase II

Primary objective

• Objective ORR in both ‘fit’ and ‘frail’ relapsed aNHL patients

Secondary objectives

• Safety and tolerability of the combination of pixantrone, rituximab, etoposide and bendamustine
• CRR
• DOR
• Progression-free survival (PFS)
• Overall survival (OS)
• Successful bridging to stem cell therapy (e.g. 2nd auto- and/or 1st allo-SCT) or other cell therapy (e.g. chimeric antigen receptor [CAR]-T cell therapy)


2. Patient eligibility criteria



Inclusion criteria

• Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicular lymphoma grade 3b). For excluded histological entities see ‘Exclusion criteria’
• Phase 1 + Phase 2 ‘fit’ patients:
Age 18-70 years at the time of inclusion
ECOG PS 0-1 at protocol entry
Deemed ‘fit’ by the treating physician
• Phase 2 ‘frail’ patients:
Age 71-85 years at the time of inclusion
and/or
ECOG PS 2-3 at protocol entry
and/or
Deemed ‘frail’ by the treating physician
• At least six months response duration since last given
course of treatment (thus: refractory patients are excluded)
• Estimated life expectancy of 3 months or longer
• Measurable disease
• Hemoglobin ≥ 8 g/dL (≥5 mmol/l)
• Platelets ≥ 100 x 109/L; ≥ 75 x 109/L permitted if bone marrow involvement
• Absolute neutrophil count ≥ 1.5 x 109/L; ≥ 1.0 x 109/L permitted if documented bone marrow involvement
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); patients with proven Gilbert’s syndrome (≤ 5 x ULN) may be enrolled.
• Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma
• Serum creatinine ≤ 2 x ULN
• Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs
• Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
• Written informed consent


Exclusion criteria

• Patients with primary refractory disease (e.g. progressing under platinum-containing or similar salvage therapy) defined as < 6 months response duration from last given course of treatment.
• High-dose therapy with autologous stem cell rescue within the last 6 months prior to study entry.
• Following T-cell lymphoma entities:
o T-cell lymphoblastic lymphoma
o Hepatosplenic T-cell lymphoma
o Extranodal NK/T, nasal type
o Subcutaneous panniculitis-like
o Primary cutaneous T-cell lymphoma
o Primary leukemic T-cell lymphoma
• Following B-cell lymphoma entities:
o Transformed indolent B-cell lymphomas
o Post-transplant B-cell lymphoproliferative disease
o HIV-associated B-cell lymphoma
• Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
• Left ventricular ejection fraction (LVEF) < 45%
• Suspected or documented central nervous system involvement by NHL
• Patients known to be antigen positive for HIV and/or hepatitis B and/or hepatitis C
• Patients with active, uncontrolled infections
• Vaccination with live, attenuated vaccines within 4 weeks of inclusion
• Pregnant and/or breastfeeding women
• History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
• Known hypersensitivity to one or more of the study drugs
• Unwillingness or inability to comply with the protocol


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



Site
Included patients *
NL-Amersfoort-Meander MC
0
NL-Den Bosch-Jeroen Bosch ziekenhuis
0
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
0
NL-Doetinchem-Slingeland Hospital
0
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
0
NL-Enschede-Medisch Spectrum Twente
0
NL-Goes-Admiraal de Ruyter ziekenhuis
0
NL-Rotterdam-Erasmus MC
0

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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