AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT02340780

Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

A Phase 2 study testing Buparlisib in people with Chronic Lymphocytic Leukemia, run by Canadian Cancer Trials Group at 6 sites in Canada.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Buparlisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
6 sitesCanada
Study dates
27 Apr 2015to 28 Apr 2020
Phase
Phase 2
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

  • Previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment
  • Age ≥ 18 years
  • ECOG Performance Status score of 0, 1 or 2
  • Patients must have a life expectancy of at least 12 weeks. Those who have previously completed curative treatment of a malignancy other than CLL will be eligible
  • Patients must have at least ONE of: Lymphocyte count ≥ 10 x 10^9/L OR at least one pathologically enlarged lymph node (≥ 2 x 2 cm) by CT scan
  • Previous therapy: Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy). There is no upper limit on number of prior regimens. Patients who have received prior autologous or allogeneic stem cell transplantation are eligible.
Show all 26Show fewer
  • Patients must have recovered (to ≤ grade 2) from all reversible toxicity related to prior systemic therapy, and have adequate washout from prior chemotherapy and investigational agents defined as the longest of:
  • two weeks
  • standard cycle length of prior regimen (e.g. 28 days for FCR)
  • 5 half-lives for investigational drugs
  • Not permitted:
  • prior treatment with buparlisib (BKM120)
  • Patients may have had radiation, provided a minimum of 21 days has elapsed prior to enrollment. Patients must have recovered from any acute toxic effects from radiation prior to registration
  • Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed if surgery was major
  • Absolute neutrophil counts (ANC): ≥ 1.0 x 10^9/L
  • Platelets ≥ 50/min x 10^9/L and more than 5 days since last transfusion
  • Creatinine clearance* ≥ 50 mL/min
  • Bilirubin** ≤ 1.5 x upper normal limit (UNL)
  • Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 1.5 x UNL or ≤ 3 x UNL if hepatic involvement with CLL
  • Potassium and calcium Within normal limits for laboratory (supplementation permitted)
  • Glucose (fasting) < 7.8 mmol/L (AND HbA1c ≤ 8% if diabetic)
  • Creatinine clearance as calculated by Cockcroft-Gault formula or by 24 hour urine measurement: Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L
  • Direct if patient known to have Gilbert's syndrome
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient registration

Who cannot join

  • Progression to high grade lymphoma (Richter's transformation) or myelodysplasia
  • Patients with known hypersensitivity to the study drug or its excipients
  • The following are exclusions for enrolment on the study:
  • Pregnant or lactating women. (N.B. All women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration).
  • Men and women of childbearing potential who do not agree to use adequate contraception: prior to study entry; while taking buparlisib and after completion of study therapy for 12 weeks in men and 4 weeks in women.
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including, but not limited to:
Show all 34Show fewer
  • active uncontrolled or serious infection (viral, bacterial or fungal);
  • pulmonary disease requiring oxygen;
  • known HIV infection or other immune deficiency disorders (except for CLL);
  • uncontrolled auto-immune hemolytic anemia (AIHA) or auto-immune thrombocytopenia (ITP)
  • acute or chronic pancreatitis
  • Uncontrolled or significant cardiovascular disease including:
  • Myocardial infarction within 12 months
  • Uncontrolled angina within 6 months
  • Clinically significant congestive heart failure (eligible if controlled and LVEF ≥ 50%)
  • Stroke, TIA or other ischemic event within 12 months
  • Severe cardiac valve dysfunction
  • Left ventricular ejection fraction < 50% (only required if symptoms suggestive or history of cardiovascular disease)
  • Uncontrolled hypertension
  • Patient has any of the following mood disorders:
  • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
  • Score of ≥ 12 on the PHQ-9 questionnaire
  • Score of ≥ 15 on the GAD-7 mood scale
  • ≥ CTCAE grade 3 anxiety
  • Patient selects a positive response of '1,2,3' to question 9 (suicidal ideation) in the PHQ-9 questionnaire
  • Patients who have received prior buparlisib (BKM120).
  • Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of buparlisib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patients who are unable to swallow capsules
  • Patients on strong CYP3A inhibitors/inducers or therapeutic doses of warfarin-like anticoagulants (must have discontinued > 7 days prior to day 1). Patients may receive low molecular weight heparin if indicated. See Appendix VII for a list of prohibited medications.
  • Patients on drugs with a known risk to induce Torsades de Pointes
  • Patients receiving high dose steroid therapy or another immunosuppressive agent. Note: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed. Patients who are on stable moderate dose corticosteroid treatment for treatment of conditions other than CLL (< dexamethasone 4 mg/day, prednisone 25 mg/day) for at least 14 days before start of study treatment are eligible.
  • Patients with known HIV positivity.
  • Patients with known CLL involvement of the central nervous system.
  • Patients with a history of other malignancies, except those which have been curatively treated and require no ongoing therapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase II Study of Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic lymphocytic leukemia.

Read the detailed description

Buparlisib has been shown to shrink tumours in animals. It has been studied in some people and seems promising but it is not clear if it can offer better results than standard treatment.

The standard or usual treatment for this disease is chemotherapy, targeted therapy or radiation, either alone or in combination.

Being tested
Buparlisib
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.

  • BuparlisibDrug

Study groups in NCT02340780
Study groupRoleWhat they receive
BuparlisibExperimental100mg daily orally every 28 days
Receives: Drug: Buparlisib

What is being measured

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

  1. Overall Response Rate

    To determine the overall response rate (complete + partial response, as defined in the protocol) to oral buparlisib in patients with relapsed and refractory chronic lymphocytic leukemia.

    Complete Response (CR): CR requires all of the criteria listed on page 31 of the protocol, maintained for a period of at least 8 weeks.

    Partial Response (PR): To define a PR, at least 1 of the criteria of Group A plus 1 of the criteria of Group B listed on page 32 of the protocol must be met and persist for ≥ 8 weeks, in the absence of any criteria definitive of progressive disease.

    Measured: 30 months

Secondary outcomes (1)

  1. Progression Free Survival

    Progression-free survival (PFS) is defined as the time in months from study entry until disease progression or death.

    Measured: 30 months

Timeline

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

  1. First posted19 Jan 2015 (estimated)
  2. Study start27 Apr 2015
  3. Primary completion21 Nov 2018
  4. Study completion28 Apr 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340780
Sponsor's protocol ID
I216
Status last verified
Apr 2020
First submitted
8 Jan 2015
Last updated
22 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Assouline S, Amrein L, Aloyz R, Banerji V, Caplan S, Owen C, Hasegawa W, Robinson S, Shivakumar S, Prica A, Peters A, Hagerman L, Rodriguez L, Skamene T, Panasci L, Chen BE, Hay AE. IND.216: a phase II study of buparlisib and associated biomarkers, raptor and p70S6K, in patients with relapsed and refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2020 Jul;61(7):1653-1659. doi: 10.1080/10428194.2020.1734594. Epub 2020 Mar 10.

    PubMed 32154751

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buparlisib in people with Chronic Lymphocytic Leukemia, run by Canadian Cancer Trials Group at 6 sites in Canada.

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 26 inclusion and 34 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Aug 2019). 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 (time frame: 30 months). 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 NCT02340780, which also lists 1 linked publication.

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 22 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in