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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 organ function: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (Subjects with Gilbert's disease will be granted exception to this rule), Creatinine clearance >30 ml/min/1.73m2 as calculated by the MDRD equation, Ejection fraction ≥ 50% measured by transthoracic echocardiogram or MUGA scan
For men, agreement to remain abstinent, or to use a condom plus an additional contraceptive method during the treatment period and for at least 5 months after the last dose of study drug (Men must agree not to donate sperm during that period of time. Male patients interested in preservation of fertility should be advised to sperm bank prior to enrollment and treatment initiation)
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 below
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I agree to follow strict birth control measures or remain abstinent during and for 5 months after treatment.
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I agree to use effective birth control or remain abstinent during and for 12 months after the study.
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My blood tests show normal bone marrow function.
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I can perform all self-care but may not be able to work.
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I have CLL that has transformed into DLBCL, confirmed by a biopsy.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

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 more

Side effects data

From 2019 Phase 1 & 2 trial • 231 Patients • NCT01691898
51%
Fatigue
44%
Diarrhoea
37%
Neuropathy peripheral
32%
Nausea
30%
Neutropenia
29%
Constipation
25%
Peripheral sensory neuropathy
24%
Insomnia
24%
Pyrexia
21%
Decreased appetite
17%
Abdominal pain
17%
Vomiting
17%
Asthenia
17%
Dyspnoea
16%
Headache
16%
Alopecia
14%
Anaemia
14%
Arthralgia
14%
Cough
13%
Hyperglycaemia
11%
Dizziness
11%
Hypokalaemia
11%
Back pain
11%
Pain in extremity
11%
Myalgia
10%
Urinary tract infection
10%
Oropharyngeal pain
10%
Vision blurred
10%
Weight decreased
10%
Dehydration
10%
Night sweats
10%
Oedema peripheral
8%
Hypomagnesaemia
8%
Paraesthesia
8%
Muscle spasms
8%
Upper respiratory tract infection
8%
Dry mouth
8%
Chills
8%
Pain
6%
Dyspepsia
6%
Musculoskeletal pain
6%
Gastrooesophageal reflux disease
6%
Chest pain
6%
Erythema
6%
Hypotension
6%
Nasal congestion
5%
Pruritus
5%
Sepsis
5%
Hypoaesthesia
5%
Dry skin
5%
Thrombocytopenia
5%
Infusion related reaction
5%
Restless legs syndrome
5%
Tachycardia
5%
Rash
5%
Epistaxis
5%
Rhinorrhoea
5%
Depression
3%
Alanine aminotransferase increased
3%
Rash pruritic
3%
General physical health deterioration
3%
Abdominal pain lower
3%
Vertigo
3%
Hyperhidrosis
3%
Peripheral motor neuropathy
3%
Acute kidney injury
3%
Dry eye
3%
Abdominal discomfort
3%
Haemorrhoids
3%
Candida infection
3%
Oral candidiasis
3%
Aspartate aminotransferase increased
3%
Blood creatinine increased
3%
Hyperuricaemia
3%
Hypophosphataemia
3%
Muscular weakness
3%
Dysgeusia
3%
Anxiety
3%
Pleural effusion
3%
Nasopharyngitis
3%
Febrile neutropenia
2%
Dysuria
2%
Clostridial sepsis
2%
Non-cardiac chest pain
2%
Herpes zoster
2%
Sinus congestion
2%
Ear pain
2%
Memory impairment
2%
Joint stiffness
2%
Rhinitis
2%
Gastroenteritis
2%
Peripheral swelling
2%
Pneumonia
2%
Bone pain
2%
Productive cough
2%
Contusion
2%
Atrial fibrillation
2%
Colonic fistula
2%
Atrial flutter
2%
Chronic kidney disease
2%
Urinary retention
2%
Cardiac failure congestive
2%
Duodenal perforation
2%
Device related infection
2%
Influenza
2%
Lung infection
2%
Septic shock
2%
Viral diarrhoea
2%
Wound secretion
2%
Ganglioneuroma
2%
Cerebrovascular accident
2%
Respiratory failure
2%
Eye pain
2%
Visual impairment
2%
Abdominal distension
2%
Abdominal pain upper
2%
Dysphagia
2%
Gastrointestinal pain
2%
Gait disturbance
2%
Procedural pain
2%
Blood potassium decreased
2%
Weight increased
2%
White blood cell count decreased
2%
Hypercalcaemia
2%
Hyponatraemia
2%
Muscle tightness
2%
Flushing
2%
Coagulopathy
2%
Cardiac failure
2%
Dysphonia
2%
Dyspnoea exertional
2%
Squamous cell carcinoma
2%
Gastrointestinal haemorrhage
2%
Upper gastrointestinal haemorrhage
2%
Sudden death
2%
Urosepsis
2%
Malaise
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
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
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
~3780
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
1,053 Previous Clinical Trials
1,330,517 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,733 Total Patients Enrolled
John Allan, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04679012 — Phase 2
Richter Syndrome Research Study Groups: Polatuzumab vedotin plus R-EPCH
Richter Syndrome Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04679012 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04679012 — Phase 2

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 illnesses is Polatuzumab Vedotin typically utilized to treat?

"Polatuzumab Vedotin is a common course of treatment for Merkel cell cancer. It has also been known to combat leukaemia, ophthalmia, sympathetic and prostate cancers as well."

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
~7 spots leftby Sep 2025