Your session is about to expire
← Back to Search
Anti-metabolites
Chemotherapy + Immunotherapy for Hodgkin's Lymphoma
Phase 2
Waitlist Available
Led By Ryan Lynch
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 30/ml per minute by Cockcroft Gault formula
Patients should not have evidence of active central nervous system lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat classical Hodgkin lymphoma. The drugs work in different ways to stop the growth of cancer cells. The combination may work better than each drug alone.
Who is the study for?
This trial is for patients with untreated classical Hodgkin lymphoma. Eligible participants include those who are not pregnant, agree to use birth control, have a good performance status (able to carry out daily activities), and adequate organ function. It's not open to individuals with severe heart conditions, active infections, other cancers (except certain skin or in situ cancers), HIV/hepatitis B/C, or those on oxygen therapy.Check my eligibility
What is being tested?
The study tests the effectiveness of combining chemotherapy drugs doxorubicin hydrochloride, vinblastine, dacarbazine with immunotherapy drug pembrolizumab in treating Hodgkin lymphoma. The goal is to see if this combination helps stop cancer cells from growing by killing them directly or disrupting their spread.See study design
What are the potential side effects?
Potential side effects may include damage to the heart muscle from doxorubicin hydrochloride; immune system changes causing inflammation in various organs due to pembrolizumab; blood cell count issues; fatigue; and nausea from chemotherapy agents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
Select...
I do not have active brain lymphoma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My Hodgkin lymphoma has not been treated before.
Select...
I can undergo at least 2 cycles of ABVD or AVD chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of 1 year after completing 2 cycles of treatment (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PART A: Number of participants who complete of 2 cycles of adriamycin, pembrolizumab, vinblastine and dacarbazine (APVD)
PART B: Event Free Survival at 1 year
Secondary outcome measures
Proportion of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) 2 negative (Deauville score 1-3) patients after 2 cycles of APVD
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (APVD)Experimental Treatment5 Interventions
PART A: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
PART B: Patients receive doxorubicin hydrochloride IV, vinblastine IV, dacarbazine IV, and pembrolizumab IV as in part A, but undergo a total of 6 treatment cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Vinblastine
1998
Completed Phase 3
~5260
Dacarbazine
2005
Completed Phase 3
~5110
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,301 Total Patients Enrolled
Ryan LynchPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
4 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or nursing and will use effective birth control if I can have children.My hemoglobin level is at least 8 g/dL.My kidney function is within the required range.I do not have severe health issues that would prevent me from receiving strong chemotherapy.My cancer can be seen on scans and is at least 1.0 cm big.I do not have active brain lymphoma.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use barrier contraception during and for 120 days after the study.I am using two birth control methods or am not having sex to join this study.I have had cancer before, but it was either skin cancer treated successfully, breast or cervical cancer that did not spread, or any cancer I've been free from for over 5 years.I have heart disease or heart failure.I have or had lung inflammation that needed steroids.My Hodgkin lymphoma has not been treated before.I can undergo at least 2 cycles of ABVD or AVD chemotherapy.I am known to be positive for HIV or hepatitis B/C.I have an autoimmune disease, but it's not vitiligo.I use supplemental oxygen.My liver function tests are within the required range.I have not received a live vaccine in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (APVD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being recruited for this research project at this time?
"The data on clinicaltrials.gov indicates that this study is currently recruiting patients. The trial was first posted on January 9, 2019 and was last updated on September 8, 2022. The study is admitting 50 patients between 1 sites."
Answered by AI
How many people are currently enrolled in this research project?
"That is correct, the online clinicaltrials.gov database shows that this study was first announced on 1/9/2019 and is still recruiting patients as of 9/8/2022. They are looking for a total of 50 people to participate at 1 location."
Answered by AI
When was Pembrolizumab cleared by the FDA?
"Although there is some evidence that Pembrolizumab is safe for human use, efficacy has not yet been proven. Therefore, it was given a score of 2."
Answered by AI
What are the unique aspects of this clinical trial?
"Pembrolizumab has a long research history, with the first trial being sponsored by Alfacell in 1997. There are now 1380 active studies taking place in 72 countries and 3405 cities."
Answered by AI
For what purpose is Pembrolizumab most commonly administered?
"Pembrolizumab is an immunotherapy agent used to treat various types of cancer, such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Are there other investigational therapies that use Pembrolizumab?
"As of now, 1380 Pembrolizumab trials are ongoing. Of these live clinical studies, 243 are in Phase 3. Most of the 58978 locations for these treatments are based in Houston, Texas."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger