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

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
Minimum Age:
Healthy Volunteers:

• 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
Ballarat Health
Eastern Health
Box Hill
Austin Health
Who do I contact about this trial?
Eliza Hawkes, MD
+61 3 9496 5763
Anne-Marie Woods, BSc
+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

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Who is this study for:Patients with Peripheral T-Cell Lymphoma
Start Date:April 1, 2021
Study Drug:Lenalidomide
Study Type:Drug
Phase: Phase 2
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Study Drug:Romidepsin+CHOP; CHOP
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