Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse DLBCL: The AvR-CHOP Study (AvR-CHOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03244176|
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphomas Non-Hodgkin's B-Cell||Drug: Avelumab||Early Phase 1|
The rationale and primary objective is to evaluate the feasibility of adding induction and maintenance Avelumab into the standard Rituximab, Cyclophosphamide, Doxyrubicin, Vincristine and Prednisolone (RCHOP) regimen in order to examine the effect of programmed death-ligand 1(PDL1) inhibition in patients with stage II, III and IV DLBCL.
• Immune related toxicity which requires discontinuation of Avelumab.
- Response rates (according to the Lugano classification for Response Criteria for NonHodgkin Lymphoma);
- Failure free survival;
- Overall survival;
- Overall toxicity of treatment (according to CTCAE v 4.0).
All patients (n=28) will receive Avelumab and rituximab 2 weekly for 2 cycles, then RCHOP chemotherapy 3 weekly for 6 cycles then Avelumab 2 weekly for 6 cycles.
The sequential treatment schedule has been designed for several reasons: concurrent Avelumab and RCHOP might result in reduced efficacy of Avelumab owing to the high dose prednisolone component of RCHOP; immune related toxicities of Avelumab given concurrently with RCHOP might result in chemotherapy dose delays and reduced chemotherapy efficacy; the Avelumab plus rituximab prephase will allow for the preliminary assessment of nonchemotherapy agents Avelumab plus rituximab in treatment naïve patients.
- Patients will be reviewed at baseline and prior to each cycle of treatment for toxicity
- Positron emission tomography-computed tomography (PET/CT) will be performed at baseline, after induction phase, after cycle 2 RCHOP, at end of Avelumab (Av) RCHOP and at end of maintenance phase Avelumab.
- Following completion of treatment, patients will be followed up for a total of 5 years (at 3,6,9,12,18,24,36,48 and 60 months posttreatment). No formal routine imaging will be performed during follow up. In patients with relapse, follow up only for survival will be every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse Large B Cell Lymphoma (DLBCL): The AvR-CHOP Study|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||July 2025|
Avelumab - Single-arm open label study
All participants will receive the following treatment:
Induction phase Avelumab at a dose of 10 mg/kg as a 1hour intravenous (IV) infusion once every 2 weeks for 2 cycles Plus Rituximab at a dose of 375mg/m2 as an IV infusion over at least 1 hour once every 2 weeks for 2 treatments
RCHOP - All participants will receive RCHOP chemotherapy treatment for 6 cycles. Each cycle will last for 21 days. Rituximab, cyclophosphamide, doxorubicin, and vincristine are given on the first day of each cycle by intravenous infusion. Prednisone is given orally from Day 1 until Day 5 of each cycle.
Maintenance phase - All participants will receive Avelumab at a dose of 10 mg/kg as a 1hour intravenous (IV) infusion once every 2 weeks for 6 cycles.
Other Name: MSB0010718C
- Immune-related toxicity [ Time Frame: 12 months ]Immune-related toxicity which requires discontinuation of Avelumab
- Response Rate [ Time Frame: 5 years ]Response Rate to Avelumab + RCHOP according to the Lugano classification for Response Criteria for Non-Hodgkin Lymphoma
- Failure Free Survival [ Time Frame: 5 years ]Duration of survival without additional systemic therapy, relapse or non-relapse mortality
- Overall Survival [ Time Frame: 5 years ]Duration of patient survival
- Overall Toxicity of Treatment [ Time Frame: 12 months ]Overall toxicity as assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244176
|Contact: Eliza Hawkes, MD||+61 3 9496 5763 ext email@example.com|
|Contact: Joanne Hakanson, BSc||+61 3 9496 3352 ext firstname.lastname@example.org|
|Heidelberg, Victoria, Australia, 3084|
|Contact: Eliza Hawkes, MD +61 3 9496 5763 ext 5763 email@example.com|
|Contact: Joanne Hakanson, BSc +61 3 9496 3352 ext 3352 firstname.lastname@example.org|
|Principal Investigator: Eliza Hawkes, MD|
|Principal Investigator: Geoff Chong, MD|
|Principal Investigator: Joseph McKendrick, MD|
|Principal Investigator:||Eliza Hawkes, MD||Austin Health|