Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

NCT02340780 | Completed Phase 2 Results DMC

• 1 other identifier: I216
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (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.

  30 months

Secondary Outcomes (1)

• Progression Free Survival

  30 months

Study Arms (1)

Buparlisib

EXPERIMENTAL

100mg daily orally every 28 days

Drug: Buparlisib

Interventions

Buparlisib DRUG

Buparlisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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

You may not qualify if:

• Progression to high grade lymphoma (Richter's transformation) or myelodysplasia
• Patients with known hypersensitivity to the study drug or its excipients
• 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:
• 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

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Novartis: collaborator

Study Sites (6)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 32154751 RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bingshu Chen
• Organization: Canadian Cancer Trials Group

bchen@ctg.queensu.ca

613-533-2430

Study Officials

• Sarit Assouline

  McGill University - Dept. Oncology, Jewish General Hospital Site, Montreal QC Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 19, 2015
• Study Start: April 27, 2015
• Primary Completion: November 21, 2018
• Study Completion: April 28, 2020
• Last Updated: August 22, 2023
• Results First Posted: August 13, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)