Study to assess the safety and efficacy of the study drug IPI-145 in Leukaemia patients compared with Ofatumumab

A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002405-61-ES

Enrollment

307

Registered

2013-12-02

Start date

2014-02-20

Completion date

Unknown

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma MedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864

Interventions

Product Name: IPI-145 Product Code: IPI-145 Pharmaceutical Form: Capsule INN or Proposed INN: Not yet available CAS Number: 1201438-56-3 Other descriptive name: IPI-145 Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Diagnosis of CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment 2. Must have received at least one prior therapy for CLL/SLL 3. Measureable nodal disease by CT 4. ECOG performance status of 0-2 5. Considered not appropriate for treatment or retreament with purine analog-based therapy 6. Cytogenetics or Fish performed within 24 months prior to randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 207 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1.History of Richter's transformation or prolymphocytic leukemia 2. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopath (ITP) 3.Prior allogeneic transplant 4.Known central nervous system (CNS) lymphoma or leukemia 5. Previous treatment with a PI3K inhibitor 6. Tyrosine kinase inhibitor within 7 days of randomization 7.Ongoing systemic bacterial, fungai, or viral infections at the time of treatment 8. Unable to receive prophylactic treatment for pneumocytosis or herpes simplex virus 9. History of tuberculosis within preceding two years 10.Prior, current or chronic hepatitis B or hepatitis C infection 11.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL);Secondary Objective: To determine the safety of IPI-145 in subjects with CLL and SLL To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s);Primary end point(s): PFS defined as time from randomization to the first documentation of progressive disease (PD) as determined by independent review or death due to any cause;Timepoint(s) of evaluation of this end point: Progression of disease or Death	—

Measure

Time frame

Main Objective: To examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL);Secondary Objective: To determine the safety of IPI-145 in subjects with CLL and SLL To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s);Primary end point(s): PFS defined as time from randomization to the first documentation of progressive disease (PD) as determined by independent review or death due to any cause;Timepoint(s) of evaluation of this end point: Progression of disease or Death

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Overall survival;Secondary end point(s): TEAEs and changes in safety laboratory values OS defined as time from randomization to death Overall Response Rate (ORR) (based on independent assessment), defined as a complete response/remission (CR), CR with incomplete marrow recovery (CRi), partial response/remission (PR), nodular PR, or PR with lymphocytosis, according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria, with modification for treatment-related lymphocytosis	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Overall survival;Secondary end point(s): TEAEs and changes in safety laboratory values OS defined as time from randomization to death Overall Response Rate (ORR) (based on independent assessment), defined as a complete response/remission (CR), CR with incomplete marrow recovery (CRi), partial response/remission (PR), nodular PR, or PR with lymphocytosis, according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria, with modification for treatment-related lymphocytosis

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Countries

Australia, Austria, Belgium, France, Germany, Hungary, Italy, New Zealand, Spain, United Kingdom, United States

Contacts

Public ContactDarlene Noci

Infinity Pharmaceuticals, Inc

Darlene.noci@infi.com0016174531391

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026