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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 below
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I am 18 years old or older.
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My blood cancer type matches CLL.
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I can swallow pills.
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I have been diagnosed with chronic lymphocytic leukemia.
Select...
My condition did not improve after 2 previous treatments.
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I can take care of myself and perform daily activities.

CORONADO CLL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
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 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT03106987
39%
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%
Pleural infection
1%
Blood albumin decreased
1%
Neuropathy peripheral
1%
Sluggishness
1%
Genital herpes
1%
Fall
1%
Gingivitis
1%
Neurotoxicity
1%
Blood alkaline phosphatase increased
1%
Rash maculo-papular
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.

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
Common treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies such as PARP inhibitors and agents targeting DNA damage repair (DDR) pathways. Olaparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to cell death, especially in cells with existing DNA repair deficiencies. RP-3500, likely a novel DDR pathway agent, would similarly exploit the impaired DNA repair mechanisms in CLL cells. These treatments are crucial for CLL patients as they offer a more precise approach, targeting the cancer cells' vulnerabilities while sparing normal cells, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Poly(ADP-ribose) polymerase inhibitor CEP-8983 synergizes with bendamustine in chronic lymphocytic leukemia cells in vitro.PARP1 expression, activity and ex vivo sensitivity to the PARP inhibitor, talazoparib (BMN 673), in chronic lymphocytic leukaemia.

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
1,105 Previous Clinical Trials
1,782,756 Total Patients Enrolled
Boyu Hu, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled
~16 spots leftby Aug 2025
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