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Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (BRIO)

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ClinicalTrials.gov Identifier: NCT03370185
Recruitment Status : Suspended (Reassessing corporate priorities.)
First Posted : December 12, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Brief Summary:
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Duvelisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Duvelisib Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi)
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Duvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Drug: Duvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: From start of treatment to first documented response, 2 cycles (58 days) ]

Secondary Outcome Measures :
  1. Treatment-Emergent adverse events (TEAEs) and changes in laboratory values [ Time Frame: From start of treatment to end of treatment plus 30 days; 7 months ]
  2. Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of PD or death due to any cause [ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months ]
  3. Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documentation of PD or death from any cause [ Time Frame: Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months ]
  4. Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks [ Time Frame: Greater than or equal to 8 weeks ]


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

Inclusion Criteria:

  1. ≥ 18 years of age.
  2. Diagnosis of CLL or SLL.
  3. Received at least one prior anti-cancer therapy for CLL or SLL.
  4. Previous exposure to BTKi and meet at least one of the criteria below:

    1. Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
    2. Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
  5. Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. Resolution of toxicities due to prior BTKi therapy to acceptable level.
  8. Willingness of male and female patients to use medically acceptable methods of birth control.
  9. Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria:

  1. Richter's transformation or prolymphocytic leukemia
  2. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  3. Received prior transplant
  4. Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
  5. Known central nervous system involvement by CLL/SLL

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): NCT03370185


Locations
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United States, Arizona
Arizona Oncology
Tempe, Arizona, United States, 85284
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Michigan
QUEST Research Institute
Royal Oak, Michigan, United States, 48073
United States, Montana
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
United States, New Jersey
Summit Medical Group
Morristown, New Jersey, United States, 07932
United States, Washington
Medical Oncology Associates PS, WA
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT03370185     History of Changes
Other Study ID Numbers: VS-0145-224
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verastem, Inc.:
Leukemia
Lymphoma
Refractory
Relapse
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell