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A Phase 3 Extension Study of Duvelisib and Ofatumumab in Patients With CLL/SLL Previously Enrolled in Study IPI-145-07

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ClinicalTrials.gov Identifier: NCT02049515
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : March 17, 2021
Information provided by (Responsible Party):

Brief Summary:
A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or Ofatumumab in Study IPI-145-07.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: IPI-145 (duvelisib) Drug: Ofatumumab Phase 3

Detailed Description:

This is an open-label, two- arm, extension study designed to enable subjects who have experienced radiologically- confirmed disease progression in Study IPI-145-07 to receive the alternative treatment (either IPI-145 or ofatumumab) than what was received during study IPI-145-07.

Subjects who have previously received ofatumumab in study IPI-145-07 will receive a starting dose of 25 mg IPI-145 BID continuously in a 21 day cycle for Cycle 1 followed by 28- day treatment cycles thereafter for up to 11 cycles or until disease progression, discontinuation from study participation, or start of subsequent therapy, whichever comes first. After completing approximately 11 cycles of treatment with duvelisib, subjects who, in the judgment of the Investigator, may derive benefit from continued treatment may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 11 cycles, subjects must have evidence of response and CLL/SLL requiring treatment according to the IWCLL/IWG by Cycle 12 Day 1.

Subjects who have previously received IPI-145 in study IPI-145-07 will receive a starting dose of 300 mg ofatumumab on Day 1 followed by seven weekly doses of 2000 mg. Thereafter, subjects will receive 2000 mg ofatumumab once every month for four months unless disease progression or unacceptable toxicity occurs. Administration of ofatumumab will not exceed the 12 doses (within 7 cycles).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07
Study Start Date : December 2013
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Arm Intervention/treatment
Experimental: IPI-145
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Drug: IPI-145 (duvelisib)
PI3K Inhibitor

Active Comparator: Ofatumumab
Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL
Drug: Ofatumumab
Other Name: Arzerra

Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Until progressive disease, death, or other anticancer therapy is initiated (up to 6 years) ]

Secondary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values [ Time Frame: Enrollment through 30 days after the last dose of either IPI-145 or Ofatumumab ]
  2. Duration of Response [ Time Frame: From the first documentation of response to the first documentation of PD or death due to any cause (up to 6 years) ]
  3. Progression-free survival (PFS) [ Time Frame: From the first dose of study treatment to the first documentation of PD or death from any cause (up to 6 years) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Received either IPI-145 or ofatumumab while participating in study IPI-145-07 and experienced radiologically-confirmed disease progression
  • Diagnosis of active CLL or SLL that meets at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment
  • Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Must meet the following laboratory parameters:

    1. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤3 x upper limit of normal (ULN)
    2. Total bilirubin ≤1.5 x ULN
    3. Serum creatinine ≤2.0 x ULN
    4. Hemoglobin ≥8.0 g/dL with or without transfusion support
    5. Platelet count ≥10,000 μL with or without transfusion support
  • For women of childbearing potential (WCBP): negative serum β-human chorionic gonadotropin (βhCG) pregnancy test within 1 week before first dose (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women ≤55 years] or 12 consecutive months [women >55 years])
  • Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
  • Ability to voluntarily sign consent for and adhere to the entire study visit schedule and all protocol requirements
  • Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any study specific screening procedures are performed

Exclusion Criteria:

  • Discontinued study participation in Verastem-sponsored IPI-145-07 study
  • Greater than 3 months from confirmed progressive disease on Study IPI-145-07
  • History of Richter's transformation or prolymphocytic leukemia
  • Autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requires >20 mg daily (QD) of prednisone (or equivalent) to maintain hemoglobin >8.0 g/dL or platelets >10,000 μL without transfusion support
  • Known central nervous system (CNS) lymphoma or leukemia; subjects with symptoms of CNS disease must have a negative computed tomography (CT) scan or negative diagnostic lumbar puncture prior to first dose
  • Use of any anticancer medication from documented PD on Study IPI-145-07 to enrollment (Note: corticosteroids to manage CLL/SLL-related symptoms are allowed)
  • Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) ( Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at Screening and/or Cycle 1 Day 1 (predose))
  • Human immunodeficiency virus (HIV) infection
  • Prior, current, or chronic hepatitis B or hepatitis C infection
  • History of alcohol abuse or chronic liver disease (other than metastatic disease to the liver)
  • Unable to receive prophylactic treatment for pneumocystis and herpes simplex virus (HSV)
  • Baseline QT interval corrected with Fridericia's method (QTcF) >480 ms NOTE: this criterion does not apply to subjects with a right or left bundle branch block (BBB)
  • Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix, bladder, or prostate not requiring treatment. Subjects with previous malignancies are eligible provided that they have been disease-free for ≥2 years
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
  • Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the subject's risk while participating in this study
  • Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
  • Subjects to receive duvelisib: Administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A within 2 weeks of starting duvelisib
  • Major surgery or invasive intervention within 4 weeks prior to first dose
  • Pregnant or breastfeeding women
  • Subjects to receive ofatumumab: hypersensitivity to ofatumumab or its excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049515

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Sponsors and Collaborators
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.
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Responsible Party: SecuraBio
ClinicalTrials.gov Identifier: NCT02049515    
Other Study ID Numbers: IPI-145-12
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by SecuraBio:
Phase 3
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents