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PARP Inhibitor
RP-3500 in combination with Olaparib for Chronic Lymphocytic Leukemia (CORONADO CLL Trial)
Phase 1 & 2
Recruiting
Led By Boyu Hu, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Immunophenotype consistent with CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
CORONADO CLL Trial Summary
This trial is testing a new combination of drugs for patients with a specific type of leukemia who have failed other treatments.
Who is the study for?
Adults (≥18 years) with chronic lymphocytic leukemia that's relapsed or refractory after at least two treatments. They must have specific genetic mutations, adequate organ function, and no major health issues like severe liver impairment or active central nervous system involvement. Participants need to be able to swallow pills, follow the study schedule, and use effective contraception.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: RP-3500 and Olaparib in patients whose leukemia cells show deficiencies in DNA damage repair pathways. It's an open-label phase Ib/II study which means everyone gets the treatment combo and researchers track its effects.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for cancer drugs like RP-3500 and Olaparib may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, diarrhea or constipation. Specific side effects will be monitored throughout the trial.
CORONADO CLL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My blood cancer type matches CLL.
Select...
I can swallow pills.
Select...
I have been diagnosed with chronic lymphocytic leukemia.
Select...
My condition did not improve after 2 previous treatments.
Select...
I can take care of myself and perform daily activities.
CORONADO CLL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Secondary outcome measures
DoR as defined as the interval of time from the date of initial documented response (PR or better as per 2018 iwCLL criteria for response) to the time of progression
OS as defined as the time from registration until death from any cause
Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by 2018 iwCLL criteria) or death from any cause
+1 moreSide effects data
From 2022 Phase 3 trial • 220 Patients • NCT0310698739%
Nausea
24%
Asthenia
18%
Fatigue
18%
Anaemia
14%
Diarrhoea
12%
Constipation
11%
Abdominal pain
11%
Vomiting
9%
Dyspnoea
9%
Abdominal pain upper
8%
Headache
7%
Cough
5%
Neutropenia
5%
Leukopenia
5%
Dizziness
5%
Blood creatinine increased
5%
Dry mouth
5%
Muscle spasms
4%
Alanine aminotransferase increased
4%
Dysgeusia
3%
Aspartate aminotransferase increased
3%
Influenza
3%
Skin infection
3%
COVID-19 pneumonia
3%
Urinary tract infection
3%
Lymphopenia
3%
Thrombocytopenia
3%
Decreased appetite
3%
Insomnia
3%
Paraesthesia
3%
Hot flush
3%
Hypertension
3%
Dyspepsia
3%
Flatulence
3%
Dry skin
3%
Back pain
3%
Platelet count decreased
3%
Contusion
3%
Blood urea increased
1%
Genital herpes
1%
Gingivitis
1%
Blood albumin decreased
1%
Sluggishness
1%
Rash maculo-papular
1%
Pleural infection
1%
Neurotoxicity
1%
Fall
1%
Neuropathy peripheral
1%
Blood alkaline phosphatase increased
1%
Radius fracture
1%
Gastroenteritis cryptosporidial
1%
Hypermagnesaemia
1%
Peripheral sensory neuropathy
1%
Tinnitus
1%
Musculoskeletal pain
1%
Cystitis
1%
Pyrexia
1%
Bronchitis
1%
COVID-19
1%
Sinusitis
1%
Oesophageal squamous cell carcinoma
1%
Hypothyroidism
1%
Hypercholesterolaemia
1%
Hypokalaemia
1%
Hypomagnesaemia
1%
Hyponatraemia
1%
Bell's palsy
1%
Sciatica
1%
Syncope
1%
Dry eye
1%
Eye irritation
1%
Vertigo
1%
Palpitations
1%
Tachycardia
1%
Hypotension
1%
Dysphonia
1%
Rhinorrhoea
1%
Aphthous ulcer
1%
Gastrooesophageal reflux disease
1%
Oropharyngeal pain
1%
Odynophagia
1%
Stomatitis
1%
Alopecia
1%
Pruritus
1%
Rash
1%
Flank pain
1%
Hypercreatinaemia
1%
Muscular weakness
1%
Myalgia
1%
Osteoporosis
1%
Illness
1%
Mucosal inflammation
1%
Oedema peripheral
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Weight decreased
1%
Bone pain
1%
Hypocalcaemia
1%
Arthritis
1%
Polyneuropathy
1%
Tremor
1%
Chest pain
1%
Creatinine renal clearance decreased
1%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib (BRCA1/2 +ve)
Placebo (BRCA1/2 +ve)
Olaparib (BRCA1/2 -ve)
Placebo (BRCA1/2 -ve)
CORONADO CLL Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase Ib: Dose EscalationExperimental Treatment1 Intervention
To assess the MTD of RP-3500 in combination with olaparib
Group II: Phase II: Dose Expansion Enrichment CohortExperimental Treatment1 Intervention
All subjects enrolled into the enrichment cohort must have a del(11q) and/or ATM mutation
Group III: Phase II: Dose Expansion Eligible Subjects CohortExperimental Treatment1 Intervention
Cohort will include all other eligible subjects for Dose Expansion.
Find a Location
Who is running the clinical trial?
Repare TherapeuticsIndustry Sponsor
8 Previous Clinical Trials
1,205 Total Patients Enrolled
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,683 Total Patients Enrolled
Boyu Hu, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently engaged in this experimental research?
"Indeed, clinicaltrials.gov verifies that this medical investigation is still recruiting patients. Initially posted on September 23rd 2022 and subsequently updated the same day, 39 participants from a single site are required to conclude the study."
Answered by AI
Are there any vacancies remaining in this experiment for participants?
"That is correct. According to clinicaltrials.gov, this research protocol which was initially posted on September 23rd 2022, is still recruiting subjects. 39 patients are needed from a single medical facility for the trial's completion."
Answered by AI
What are the expected results of this medical experiment?
"The primary goal of this investigation, which is to span a decade in duration, is to evaluate the Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period. Secondary objectives include measuring overall survival (OS), progression-free survival (PFS), and duration of response (DoR)."
Answered by AI
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