Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse Large B Cell Lymphoma (DLBCL): The AvR-CHOP Study

Trial Information
Who is this study for? Patients with diffuse large B cell lymphoma
What treatments are being studied? Avelumab
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
Summary

To evaluate the feasibility of adding induction and maintenance Avelumab to the standard combination of R-CHOP in patients with stage II, III and IV diffuse large B cell lymphoma (DLBCL)

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• Male or Female subjects aged 18 years.

• Histologically proven CD20-positive diffuse large B cell non-Hodgkin lymphoma (DLBCL) according to the current World Health Organization classification including all morphological variants.

• No previous treatment for lymphoma including chemotherapy, radiotherapy or other investigational drug.

• Stage II, III and IV disease (Ann Arbor criteria) (must be able to undergo PET/CT imaging for staging purposes.)

• Eastern Collaborative Oncology Group performance status 0, or 1, unless attributable to lymphoma in which case patients of performance status 2 are also eligible.

• Adequate bone marrow function with platelets > 100x109/l; neutrophils > 1.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma.

• Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)

• Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × upper limit of institutional normal range unless attributed to lymphoma.

• Patients must have an acceptable left ventricular ejection fraction (LVEF) i.e. within the local normal range for multigated acquisition scan (MUGA) or ≥ 45% on echocardiogram

• No concurrent uncontrolled medical condition as determined by the investigator.

• Life expectancy > 3 months.

• Negative blood pregnancy test at screening for women of childbearing potential. Effective contraception for both male and female subjects if the risk of conception exists.

• Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.

Where is this trial taking place?
Other Locations
Australia
Ballarat Health
Recruiting
Ballarat
Eastern Health
Recruiting
Box Hill
Austin Health
Recruiting
Heidelberg
Who do I contact about this trial?
Primary
Eliza Hawkes, MD
eliza.hawkes@onjcri.org.au
+61 3 9496 5763
Backup
Anne-Marie Woods, BSc
Anne-Marie.WOODS@austin.org.au
+61 3 9496 3352
When is this trial taking place?
Start Date: July 21, 2017
Estimated Completion Date: July 2025
How many participants will be in this trial?
Target number of participants: 28
What treatment is being studied in this trial?
Other: Open-label
Avelumab - Single-arm open label study
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov

Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Who is this study for:Patients with Peripheral T-Cell Lymphoma
Status:Recruiting
Start Date:April 1, 2021
Study Drug:Lenalidomide
Study Type:Drug
Phase: Phase 2
Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Who is this study for:Patients with previously untreated peripheral T-cell lymphoma
Status:Active, not recruiting
Start Date:January 2013
Study Drug:Romidepsin+CHOP; CHOP
Study Type:Drug
Phase: Phase 3