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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02049515




Registration number
NCT02049515
Ethics application status
Date submitted
28/01/2014
Date registered
30/01/2014
Date last updated
21/09/2023

Titles & IDs
Public title
A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07
Scientific 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)
Secondary ID [1] 0 0
2013-003639-31
Secondary ID [2] 0 0
IPI-145-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IPI-145
Treatment: Drugs - Ofatumumab

Experimental: IPI-145 - IPI-145 was administered orally and supplied as 5 mg and 25 mg formulated capsules.

Active comparator: Ofatumumab - Ofatumumab 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.


Treatment: Drugs: IPI-145
PI3K Inhibitor

Treatment: Drugs: Ofatumumab
Monoclonal antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Until progressive disease (PD), death, or other anticancer therapy is initiated (up to 4.5 years)
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
From the first documentation of response to the first documentation of PD or death due to any cause (up to 4.5 years)
Secondary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
From the first dose of study treatment to the first documentation of PD or death from any cause (up to 4.5 years)

Eligibility
Key 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 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:

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 grams/deciliter (g/dL) with or without transfusion support
5. Platelet count =10,000 microliters (µL) with or without transfusion support
* For women of childbearing potential (WCBP): negative serum ß-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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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)
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2020
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3058 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Austria
State/province [11] 0 0
Linz
Country [12] 0 0
Austria
State/province [12] 0 0
Vienna
Country [13] 0 0
Austria
State/province [13] 0 0
Wels
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Sint-Niklaas
Country [19] 0 0
France
State/province [19] 0 0
Argenteuil Cedex
Country [20] 0 0
France
State/province [20] 0 0
Bobigny
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Caen
Country [23] 0 0
France
State/province [23] 0 0
Clermont Ferrand
Country [24] 0 0
France
State/province [24] 0 0
La Roche Sur Yon
Country [25] 0 0
France
State/province [25] 0 0
Limoges Cedex
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
France
State/province [28] 0 0
Vandœuvre-lès-Nancy
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Leer
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyor
Country [35] 0 0
Hungary
State/province [35] 0 0
Kaposvár
Country [36] 0 0
Hungary
State/province [36] 0 0
Pecs
Country [37] 0 0
Hungary
State/province [37] 0 0
Szeged
Country [38] 0 0
Italy
State/province [38] 0 0
Catania
Country [39] 0 0
Italy
State/province [39] 0 0
Lecce
Country [40] 0 0
Italy
State/province [40] 0 0
Meldola
Country [41] 0 0
Italy
State/province [41] 0 0
Milano
Country [42] 0 0
Italy
State/province [42] 0 0
Padova
Country [43] 0 0
Italy
State/province [43] 0 0
Ravenna
Country [44] 0 0
Italy
State/province [44] 0 0
Rimini
Country [45] 0 0
Italy
State/province [45] 0 0
Roma
Country [46] 0 0
New Zealand
State/province [46] 0 0
Auckland
Country [47] 0 0
New Zealand
State/province [47] 0 0
Palmerston North
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Pamplona
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Bournemouth
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Leeds
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Manchester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Nottingham
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Oxford
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SecuraBio
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 (NCT02004522).
Trial website
https://clinicaltrials.gov/study/NCT02049515
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hagop Youssoufian, MD
Address 0 0
Verastem, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02049515