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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 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
Must not have
Major surgery within 4 weeks before the start of Cycle 1 day 1. Superficial lymph node biopsies or laprascopic lymph node biopsies are exclusionary to this rule.
Subject is known to be positive for HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of drugs to treat patients with a severe type of lymphoma. The treatment aims to kill cancer cells and boost the immune system. Patients will be monitored closely for an extended period to see how well they respond.

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.
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.
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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 4 weeks, except for minor lymph node biopsies.
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I am HIV positive.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I do not have serious heart conditions like recent heart attacks or unstable heart disease.
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My cancer has spread to my brain or central nervous system.
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I have received treatment for Richter's transformation before.
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My condition is Richter's Transformation, not the DLBCL type.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT)
Secondary study objectives
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
58%
Fatigue
46%
Neuropathy peripheral
42%
Diarrhoea
42%
Nausea
29%
Peripheral sensory neuropathy
29%
Decreased appetite
27%
Asthenia
25%
Neutropenia
25%
Cough
24%
Constipation
22%
Vomiting
20%
Pain in extremity
19%
Abdominal pain
19%
Arthralgia
19%
Dyspnoea
17%
Dizziness
17%
Anaemia
15%
Pyrexia
14%
Hypokalaemia
14%
Insomnia
14%
Dyspepsia
14%
Back pain
14%
Influenza like illness
14%
Oedema peripheral
14%
Headache
12%
Weight decreased
12%
Alopecia
10%
Chest pain
10%
Muscular weakness
10%
Pruritus
10%
Muscle spasms
10%
Hypomagnesaemia
10%
Bone pain
10%
Myalgia
8%
Peripheral motor neuropathy
8%
Dry mouth
8%
Musculoskeletal pain
8%
Anxiety
7%
Neutrophil count decreased
7%
Abdominal pain upper
7%
Chills
7%
White blood cell count decreased
7%
Hyperglycaemia
7%
Hyperhidrosis
7%
Night sweats
7%
Depression
5%
Dehydration
5%
Hypophosphataemia
5%
Memory impairment
5%
Dysuria
5%
Productive cough
5%
Taste Disorder
5%
Tachycardia
5%
Abdominal discomfort
5%
Gait disturbance
5%
Dysgeusia
5%
Hypertension
5%
Rash
3%
Thrombocytopenia
3%
Peripheral swelling
3%
Urinary tract infection
3%
Alanine aminotransferase increased
3%
Hypoaesthesia
3%
Febrile neutropenia
3%
Upper respiratory tract infection
3%
Vision blurred
3%
Abdominal distension
3%
Toothache
3%
Oral candidiasis
3%
Hyponatraemia
3%
Nasal congestion
3%
Dysphonia
3%
Acute kidney injury
3%
Malaise
3%
Fall
2%
Orthostatic hypotension
2%
Vertigo
2%
Abdominal pain lower
2%
Sinusitis
2%
Contusion
2%
Gout
2%
Benign neoplasm of skin
2%
Erythema
2%
Rash pruritic
2%
Skin Abrasion
2%
Paraesthesia
2%
Haematoma
2%
Hernial eventration
2%
General physical health deterioration
2%
Cholecystitis acute
2%
Pulmonary congestion
2%
Influenza
2%
Pharyngitis
2%
Groin pain
2%
Restless legs syndrome
2%
Syncope
2%
Tremor
2%
Rash erythematous
2%
Gastroenteritis viral
2%
Pancreatitis
2%
Rectal haemorrhage
2%
Subileus
2%
Axillary pain
2%
Hepatic steatosis
2%
Hepatocellular injury
2%
Hepatomegaly
2%
Bronchitis
2%
Clostridium difficile infection
2%
Febrile infection
2%
Lung disorder
2%
Hypotension
2%
Lymphadenopathy
2%
Ear discomfort
2%
Visual impairment
2%
Pain
2%
Oesophageal candidiasis
2%
Aspartate aminotransferase increased
2%
Blood creatinine increased
2%
Platelet count decreased
2%
Hypercalcaemia
2%
Hyperuricaemia
2%
Hypoxia
2%
Dermatitis acneiform
2%
Nasopharyngitis
2%
Infusion related reaction
2%
Epistaxis
2%
Chest discomfort
2%
Fistula of small intestine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2960
Prednisone
2014
Completed Phase 4
~2500
Cyclophosphamide
2010
Completed Phase 4
~2310
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Rituximab
1999
Completed Phase 4
~2990

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Polatuzumab vedotin is an antibody-drug conjugate that targets CD79b, a protein expressed on the surface of B cells, including those involved in Richter Syndrome. By binding to CD79b, Polatuzumab vedotin delivers a cytotoxic agent directly to the cancer cells, leading to their destruction. This targeted approach helps to minimize damage to healthy cells. In combination with chemotherapy agents like rituximab, etoposide, prednisone, cyclophosphamide, and hydroxydaunorubicin, the treatment aims to enhance the overall anti-cancer effect by attacking the cancer cells through multiple mechanisms. This is crucial for Richter Syndrome patients, as the disease is aggressive and often resistant to standard therapies, necessitating a robust and multifaceted treatment strategy.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,079 Previous Clinical Trials
1,137,880 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,280 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
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