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Stem Cell Transplant + Polatuzumab for Lymphoma
Phase 1 & 2
Recruiting
Led By Aliza Gardenswartz, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.
Age Maximum Serum Creatinine (mg/dL) Male Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing two different ways to prepare patients for a stem cell transplant, and whether a new drug can help keep the cancer from coming back.
Who is the study for?
This trial is for patients with various types of B-cell and Hodgkin Lymphoma who have had a relapse or are not responding well to initial treatments. They must be over 16, have a life expectancy greater than 6 weeks, and show adequate organ function. Patients can't join if they're pregnant, breastfeeding, have severe neuropathy, active CNS lymphoma, uncontrolled infections or are using other investigational drugs.Check my eligibility
What is being tested?
The study tests Polatuzumab Vedotin in patients post-autologous stem cell transplant (ASCT). Participants will first undergo one of two chemotherapy regimens before ASCT. If they respond well to ASCT, they'll receive Polatuzumab Vedotin every three weeks for up to eight doses.See study design
What are the potential side effects?
Polatuzumab Vedotin may cause side effects such as nerve damage (neuropathy), infusion reactions similar to allergic responses during drug administration, liver problems indicated by abnormal blood tests results and potentially low blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities by myself.
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My kidney function, measured by creatinine levels, is within the normal range for my age and gender.
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My liver enzymes are within normal limits for my age.
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I have recovered from side effects of my previous cancer treatments.
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I am at least 16 years old.
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My organs are functioning well.
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I have enough stem cells collected and stored for my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability
Secondary outcome measures
EFS, PFS, and OS
ORR
Trial Design
1Treatment groups
Experimental Treatment
Group I: Polatuzumab vedotinExperimental Treatment1 Intervention
Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety.
Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable.
Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.
Find a Location
Who is running the clinical trial?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,041 Total Patients Enrolled
Aliza Gardenswartz, MDPrincipal InvestigatorNew York Medical College
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell collection from my blood.I have never had a stem cell transplant.My kidney function, based on my age and gender, is within the required range.I do not have any infections that aren't responding to treatment.My kidney function is normal.I can do most of my daily activities by myself.I do not have severe nerve damage.It has been over a week since my last biologic treatment.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.My cancer did not fully respond to initial treatment but improved or remained stable after more therapy.I haven't had chemotherapy that lowers blood cell counts in the last 2 weeks (4 weeks for a specific type).This criterion seems to be incomplete or unclear. Please provide more context.My lungs are working well.My liver enzymes are within normal limits for my age.My breathing rate is normal for my age and my oxygen level is above 94% without assistance.I have recovered from side effects of my previous cancer treatments.I have been diagnosed with a type of B-cell non-Hodgkin lymphoma.My heart is functioning well.You are currently taking any other experimental drugs for the treatment of B-cell lymphoma.I agree to use effective birth control during the study.I am at least 16 years old.I do not have active brain lymphoma.My liver is working well.My organs are functioning well.I have enough stem cells collected and stored for my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Polatuzumab vedotin
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.
Is this research only being conducted with middle-aged or younger patients?
"This study is looking for patients aged 12 to 70. Out of the 1696 trials for people over the age of 65, this one is 311th."
Answered by AI
How many people are total are participants in this research project?
"Yes, an edited version of the clinical posting was uploaded on 8/1/2021 and can be found on clinicaltrials.gov. The current posting is from 10/29/2021 and is seeking 20 patients from 1 medical facility."
Answered by AI
Is this the first instance of Polatuzumab vedotin being trialed?
"Polatuzumab vedotin is being trialed in 21 active studies, 4 of which have reached Phase 3. Most of the research locations for Polatuzumab vedotin are in Prague and Virginia; however, there are a total of 739 sites running these investigations."
Answered by AI
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