A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
Recruiting at83 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: SecuraBio
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Research Team
DC
David Cohan, MD
Principal Investigator
SecuraBio Chief Medical Officer
Eligibility Criteria
Inclusion Criteria
Diagnosis of active CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment (Binet Stage ≥ B and/or Rai Stage ≥ I)
Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy
Not appropriate for treatment with a purine-based analogue regimen (per National Comprehensive Cancer Network [NCCN] or European Society for Medical Oncology [ESMO] guidelines), including relapse ≤ 36 months from a purine-based chemoimmunotherapy regimen or relapse ≤ 24 months from a purine-based monotherapy regimen
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Treatment Details
Interventions
- Duvelisib (PI3K Inhibitor)
- Ofatumumab (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DuvelisibExperimental Treatment1 Intervention
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Group II: OfatumumabActive Control1 Intervention
Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
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Who Is Running the Clinical Trial?
SecuraBio
Lead Sponsor
Trials
29
Recruited
2,400+