Your session is about to expire
← Back to Search
Alkylating agents
Polatuzumab Vedotin + Chemotherapy for Richter Syndrome
Phase 2
Recruiting
Led By John Allan, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have adequate bone marrow function: Absolute neutrophil count of ≥1000 cell/uL, Hemoglobin ≥ 7 g/dL, Platelet count ≥ 30,000 cells/uL
Subject must have an Eastern Cooperative Oncology Group performance status of ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug, Polatuzumab vedotin, to see if it is effective and safe when combined with other existing cancer drugs.
Who is the study for?
Adults diagnosed with chronic B-cell leukemia or Richter's Syndrome, who have a life expectancy of at least 24 weeks and are in relatively good health (ECOG ≤2). They must have normal organ function and bone marrow activity. Women of childbearing age must use effective contraception, as must men, who should also not donate sperm during the trial.Check my eligibility
What is being tested?
The trial is testing Polatuzumab Vedotin combined with chemotherapy drugs (rituximab, etoposide, prednisone, cyclophosphamide, hydroxydaunorubicin) for treating Richter's Transformation. Patients will undergo six cycles of treatment over 21 days each and be monitored weekly until end of treatment followed by long-term follow-ups.See study design
What are the potential side effects?
Possible side effects include reactions to infusion treatments like fever or chills; low blood cell counts leading to increased infection risk; nausea; hair loss from chemotherapy; fatigue; neuropathy which is numbness or tingling in hands and feet; heart issues due to doxorubicin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal bone marrow function.
Select...
I can perform all self-care but may not be able to work.
Select...
I have CLL that has transformed into DLBCL, confirmed by a biopsy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT)
Secondary outcome measures
Allogeneic transplantation rate in eligible patients
Overall response rate (ORR)
Overall survival (OS)
+2 moreSide effects data
From 2019 Phase 1 & 2 trial • 231 Patients • NCT0169189835%
Diarrhoea
35%
Nausea
23%
Fatigue
20%
Constipation
20%
Asthenia
20%
Neutropenia
20%
Neuropathy peripheral
20%
Dyspnoea
15%
Pain in extremity
15%
Headache
15%
Insomnia
15%
Cough
13%
Hypokalaemia
13%
Vomiting
13%
Chills
13%
Decreased appetite
13%
Back pain
10%
Thrombocytopenia
10%
Abdominal distension
10%
Anaemia
10%
Abdominal pain upper
10%
Hyperglycaemia
10%
Dizziness
10%
Hypotension
8%
Pyrexia
8%
Abdominal pain
8%
Nasal congestion
8%
Oropharyngeal pain
8%
Pruritus
8%
Paraesthesia
8%
Dyspepsia
8%
Oedema peripheral
8%
Infusion related reaction
8%
Arthralgia
5%
Atrial fibrillation
5%
Fall
5%
Herpes zoster
5%
Tooth infection
5%
Dehydration
5%
Candida infection
5%
Pneumonia
5%
Platelet count decreased
5%
Peripheral sensory neuropathy
5%
Productive cough
5%
Rhinorrhoea
5%
Dry skin
5%
Urinary tract infection
5%
Pleural effusion
5%
Gait disturbance
5%
Oral candidiasis
5%
Aspartate aminotransferase increased
5%
Hypercalcaemia
5%
Hypomagnesaemia
5%
Dysphonia
5%
Hypoxia
5%
Haematoma
5%
Epistaxis
5%
Dysphagia
5%
Contusion
3%
Dry mouth
3%
Malaise
3%
White blood cell count decreased
3%
Ear pain
3%
Lipase increased
3%
Hyperuricaemia
3%
Hypophosphataemia
3%
Pain
3%
Hypoaesthesia
3%
Erythema
3%
Night sweats
3%
Flushing
3%
Taste Disorder
3%
Upper respiratory tract infection
3%
Depression
3%
Acute kidney injury
3%
Cardiac failure
3%
Gastrointestinal haemorrhage
3%
Bile duct obstruction
3%
Hyperbilirubinaemia
3%
Sepsis
3%
Cachexia
3%
Pulmonary embolism
3%
Vision blurred
3%
Abdominal discomfort
3%
Gastrooesophageal reflux disease
3%
Chest pain
3%
Alanine aminotransferase increased
3%
Blood creatinine increased
3%
Neutrophil count decreased
3%
Musculoskeletal pain
3%
Sneezing
3%
Alopecia
3%
Hyperhidrosis
3%
Rash
3%
Febrile neutropenia
3%
Dyspnoea exertional
3%
Restless legs syndrome
3%
Tremor
3%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Cohort C (FL): RTX + Polatuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Polatuzumab vedotin plus R-EPCHExperimental Treatment6 Interventions
Polatuzumab vedotin will be given in conjunction with 6 cycles of R-EPCH (rituximab, etoposide, prednisone, cyclophosphamide, hydroxydaunorubicin). The dosing schedule and regimen for R-EPCH will follow established protocols. Polatuzumab vedotin will be administered on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3770
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,057 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,005 Total Patients Enrolled
John Allan, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks, except for minor lymph node biopsies.I do not have any major health issues that could interfere with the study.I agree to follow strict birth control measures or remain abstinent during and for 5 months after treatment.I am HIV positive.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have any current infections or major infections in the last 4 weeks.I have active hepatitis C or B, or had hepatitis B with a negative PCR.I had cancer before, but it was treated and hasn't come back in 3 years, except for non-melanoma skin or cervical cancer.I agree to use effective birth control or remain abstinent during and for 12 months after the study.I am currently on targeted CLL therapy but haven't changed or added new treatments recently.My blood tests show normal bone marrow function.I can perform all self-care but may not be able to work.You are expected to live for at least 6 months.I have CLL that has transformed into DLBCL, confirmed by a biopsy.I do not have serious heart conditions like recent heart attacks or unstable heart disease.My cancer has spread to my brain or central nervous system.I am 18 years old or older.I have received treatment for Richter's transformation before.I had a stem cell transplant for CLL less than 6 months ago.My condition is Richter's Transformation, not the DLBCL type.You have had serious allergic reactions in the past to certain types of medications called humanized or murine monoclonal antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Polatuzumab vedotin plus R-EPCH
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 enrollment still open for this investigation?
"Affirmative. The information available on clinicaltrials.gov attests that this medical study, which was initially shared on September 24th 2021, is actively seeking participants. Specifically, 20 individuals need to be enrolled from one location."
Answered by AI
What is the current enrollment capacity for this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this medical trial, uploaded on September 24th 2021, is actively enrolling patients for participation. Currently, 20 participants must be found among 1 site."
Answered by AI
Has the Federal Drug Administration sanctioned Polatuzumab Vedotin?
"Our team at Power evaluated the safety of Polatuzumab Vedotin and assigned it a rating of 2, as this is only in Phase 2 trials; indicating that there exists some evidence for its safety but no studies showing efficacy."
Answered by AI
Has Polatuzumab Vedotin been tested in any prior research experiments?
"Presently, 1570 studies in regards to Polatuzumab Vedotin are ongoing. Of these trials, 346 are at the Phase 3 stage and 59006 different medical sites have been tapped for research purposes - with Bethesda, Maryland serving as a major hub of activity."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger