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Chronic Lymphocytic LeukemiaPhase 3NCT02049515

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

A Phase 3 study testing IPI-145 and Ofatumumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SecuraBio at 69 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IPI-145 and Ofatumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
69 sitesin 11 countries
Study dates
Dec 2013to 12 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 met at least one of the IWCLL 2008 criteria for requiring treatment
  • Measurable disease with a lymph node or tumor mass >1.5 centimeters in at least one dimension as assessed by computed tomography (CT)
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Must have met the following laboratory parameters:
  • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤3 x upper limit of normal (ULN)
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  • Total bilirubin ≤1.5 x ULN
  • Serum creatinine ≤2.0 x ULN
  • Hemoglobin ≥8.0 grams/deciliter (g/dL) with or without transfusion support
  • Platelet count ≥10,000 microliters (μL) with or without transfusion support
  • For women of childbearing potential (WCBP): negative serum β-human chorionic gonadotropin pregnancy test within one week before first dose (WCBP defined as a sexually mature woman who had not undergone surgical sterilization or who had 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 participants who were 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 have used 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/independent ethics committee-approved informed consent form before any study-specific screening procedures are performed

Who cannot join

  • 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 or idiopathic thrombocytopenia purpura that was uncontrolled or requires >20 mg daily 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; participants with symptoms of CNS disease must have had a negative CT scan or negative diagnostic lumbar puncture prior to first dose
  • Use of any anticancer medication from documented progressive disease on Study IPI-145-07 to enrollment (Note: corticosteroids to manage CLL/SLL-related symptoms were allowed)
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  • Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) (Participants 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 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
  • Baseline QT interval corrected with Fridericia's method >480 milliseconds Note: this criterion did not apply to participants with a right or left bundle branch block
  • Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix, bladder, or prostate not requiring treatment. Participants with previous malignancies were eligible provided that they had 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 (for example, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, have increased the participant's risk while participating in this study
  • Prior surgery or gastrointestinal dysfunction that may have affected drug absorption (for example, gastric bypass surgery, gastrectomy)
  • Participants to receive duvelisib: Administration of medications or foods that were strong inhibitors or inducers of cytochrome P450 3A within 2 weeks of starting duvelisib
  • Major surgery or invasive intervention within 4 weeks prior to first dose
  • Pregnant or breastfeeding women
  • Participants to receive ofatumumab: hypersensitivity to ofatumumab or its excipients.

Trial locations and contacts

69 sites in 11 countries.

69 sites in 11 countries

United States14 sites

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Charlottesville, Virginia, 22903

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Denver, Colorado, 80218

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    La Jolla, California, 92093-0698

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    New York, New York, 10032

  • Study site

    New York, New York, 10065

  • Study site

    St Louis, Missouri, 63130

  • Study site

    St. Petersburg, Florida, 33705

Other trials in United States

France10 sites

  • Study site

    Argenteuil, 95107

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33076

  • Study site

    Caen, 14033

  • Study site

    Clermont-Ferrand, 63100

  • Study site

    La Roche-sur-Yon, 85025

  • Study site

    Limoges, 87042

  • Study site

    Nantes, 44000

  • Study site

    Rennes, 35033

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy9 sites

  • Study site

    Catania, 95124

  • Study site

    Lecce, 73100

  • Study site

    Meldola, 47014

  • Study site

    Milan, 20132

  • Study site

    Milan, 20162

  • Study site

    Padova, 35128

  • Study site

    Ravenna, 48121

  • Study site

    Rimini, 47923

  • Study site

    Roma, 00133

Other trials in Italy

Hungary7 sites

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1122

  • Study site

    Debrecen, 4032

  • Study site

    Győr, 9024

  • Study site

    Kaposvár, 7400

  • Study site

    Pécs, 7624

  • Study site

    Szeged, 6725

Other trials in Hungary

Spain6 sites

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28050

  • Study site

    Pamplona, 31008

Other trials in Spain

United Kingdom6 sites

  • Study site

    Bournemouth, BH7 7DW

  • Study site

    Leeds, LS9 7TF

  • Study site

    Manchester, M20 4BX

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Oxford, OX3 7JL

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium5 sites

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1200

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Sint-Niklaas, 9100

Other trials in Belgium

Austria4 sites

  • Study site

    Linz, 4010

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Wels, 4600

Other trials in Austria

Australia3 sites

  • Study site

    Bedford Park, 5042

  • Study site

    East Melbourne, 3002

  • Study site

    Melbourne, 3058

Other trials in Australia

Germany3 sites

  • Study site

    Berlin, 10707

  • Study site

    Leer, 26789

  • Study site

    Ulm, 89081

Other trials in Germany

New Zealand2 sites

  • Study site

    Auckland, 1023

  • Study site

    Palmerston North, 4442

Other trials in New Zealand

About this study

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 Duvelisib (IPI-145)

A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants 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 (NCT02004522).

Read the detailed description

The study was designed as an open-label, two-arm extension evaluation to enable participants who experienced radiologically confirmed disease progression in study IPI-145-07 to receive the alternative treatment (either IPI-145 or ofatumumab) other than what was received during study IPI-145-07.

Participants who previously had received ofatumumab in study IPI-145-07 received a starting dose of 25 milligrams (mg) IPI-145 twice daily 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 occurred first. After completing approximately 11 cycles of treatment with duvelisib, participants who, in the judgment of the investigator, may have derived benefit from continued treatment may have continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 11 cycles, participants must have had evidence of response and CLL/SLL requiring treatment according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL)/International Working Group by Cycle 12 Day 1.

Participants who previously received IPI-145 in study IPI-145-07 received treatment consistent approved product labeling which consisted of a starting dose of 300 mg ofatumumab on Day 1, followed by seven weekly doses of 2000 mg. Thereafter, participants received 2000 mg ofatumumab once every month for four months unless disease progression or unacceptable toxicity occurred. Administration of ofatumumab was not to exceed the 12 doses (within 7 cycles).

Being tested
IPI-145, Ofatumumab
Keywords
Phase 3, CLL/SLL, PI3K
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPI-145Drug

    Also called Duvelisib, Copiktra, PI3K Inhibitor

    PI3K Inhibitor

  • OfatumumabDrug

    Also called Arzerra

    Monoclonal antibody

Study groups in NCT02049515
Study groupRoleWhat they receive
IPI-145ExperimentalIPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.
Receives: Drug: IPI-145
OfatumumabActive comparatorOfatumumab was administered as an intravenous (IV) infusion and was supplied in single-use vials at two strengths, 100 mg/5 milliliters (mL) and 1000 mg/50 mL.
Receives: Drug: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of participants with a best response (per investigator assessment) of complete response (CR), CR with incomplete marrow recovery (CRi), partial response (PR), or PR with lymphocytosis (PRwL), according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) or revised International Working Group Response (IWG) Criteria, with modification for treatment-related lymphocytosis. The 95% confidence interval was calculated using exact binomial method. Select IWCLL criteria for tumor load assessed by computed tomography (CT): CR/CRi (CLL only), lymphadenopathy (none >1.5 centimeters [cm]), hepatomegaly/splenomegaly (none); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%). Select IWG criteria for tumor load assessed by CT: CR, lymphadenopathy/hepatomegaly/splenomegaly (normal size); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%).

    Measured: Until progressive disease (PD), death, or other anticancer therapy is initiated (up to 4.5 years)

Secondary outcomes (2)

  1. Duration of Response (DOR)

    DOR was defined as the time from the first documentation of response per investigator assessment to either PD or death due to any cause. DOR was evaluated using the Kaplan-Meier method based on all treated participants with a documentation of response (that is, CR, CRi, PR, or PRwL) as determined by investigator assessment. Select IWCLL criteria for tumor load assessed by CT: CR/CRi (CLL only), lymphadenopathy (none >1.5 cm), hepatomegaly/splenomegaly (none); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%). Select IWG criteria for tumor load assessed by CT: CR, lymphadenopathy/hepatomegaly/splenomegaly (normal size); PR, lymphadenopathy/hepatomegaly/splenomegaly (decrease ≥50%); PRwL, lymphadenopathy only (decrease ≥50%).

    Measured: From the first documentation of response to the first documentation of PD or death due to any cause (up to 4.5 years)

  2. Progression-free Survival (PFS)

    PFS was defined as the time from the first dose of study treatment to the first documentation of either investigator-assessed PD or death resulting from any cause. PFS was determined using the Kaplan-Meier method based on all treated participants with a documentation of response (that is, CR, CRi, PR, or PRwL) as determined by investigator assessment.

    Measured: From the first dose of study treatment to the first documentation of PD or death from any cause (up to 4.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completion12 Jun 2020
  4. Study completion12 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02049515
Sponsor's protocol ID
IPI-145-12
Other IDs
2013-003639-31
Status last verified
Sep 2023
First submitted
28 Jan 2014
Last updated
21 Sep 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPI-145 and Ofatumumab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SecuraBio at 69 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, France, Italy, Hungary, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Until progressive disease (PD), death, or other anticancer therapy is initiated (up to 4.5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02049515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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