sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON-associated MEDI4736-NHL-001


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


return to top

News


No news


1. Overview



Summary

A phase 1-2, open label, multicenter study to assess the safety and tolerability of Durvalumab (Anti-PD-L1 antibody) as monotherapy and in combination therapy in subjects with lymphoma and chronic lymphocytic leukemia.


Status

closed


Members

The study is now open in (for phase I parts)
• Erasmus MC (p.lugtenburg@erasmusmc.nl)
• AMC (a.p.kater@amc.uva.nl)
• UMCG (t.van.meerten@umcg.nl)
• LUMC (j.s.p.vermaat@lumc.nl)


Please inform first if there is a slot available for your patient before referring the patient to our centers.



Study details



Type of study

Prospective Phase I/II study


2. Patient eligibility criteria



Inclusion criteria

• ≥ 18 years
• Histologically confirmed (local PA) histologies:
Phase 1 dose finding cohort: CLL/SLL, MCL, FL, nodal MZL, splenic MZL, DLBCL, PMBCL, transformed lymphoma, ALK pos large B-cell lymphoma, Richters transformation
Phase I dose confirmation cohort: CLL/SLL, MCL, FL, DLBCL en Hodgkin Lymfoom
Phase II dose expansion cohort: CLL/SLL, MCL, FL, DLBCL
• Documented active relapsed or refractory disease requiring therapeutic intervention
• Previously treated with at least one prior systemic therapy, immunotherapy, or chemoimmunotherapy
• NHL: willing to undergo biopsy. Exception: archival diagnostic biopsy available within 18 months prior to signing IC
• CLL: willing to undergo BM biopsy
• Measurable disease:
Lymphoma: on CT scan at least one nodal or extranodal lesion ≥ 2 cm in its longest dimension
CLL: in need of treatment according to IWCLL guidelines
• WHO performance status 0-2
• Eligible laboratory values: differs per arm: see protocol


Exclusion criteria

• CNS lymphomqa, blastoid variants MCL
• Dose confirmation/expansion part: transformed lymphoma and Richter’s transformation
• Allogeneic SCT
• Primary immunodeficiency or TBC
• Active autoimmune disease
• HIV, hepatitis C, active hepatitis B
• Steroid treatment > 10 mg/day during week prior to Day 1 Cycle 1
• Invasive malignancy < 2 years


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




return to top