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Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

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ClinicalTrials.gov Identifier: NCT02337829
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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

Detailed Description:
To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Using ACP-196 in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Anti-Tumor Response
Study Start Date : December 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: A
to undergo superficial lymph node biopsies
Drug: acalabrutinib
Patients undergo lymph node biopsies
Other Name: ACP-196

Drug: acalabrutinib
Patients undergo bone marrow biopsies
Other Name: ACP-196

Experimental: B
to undergo bone marrow biopsies
Drug: acalabrutinib
Patients undergo lymph node biopsies
Other Name: ACP-196

Drug: acalabrutinib
Patients undergo bone marrow biopsies
Other Name: ACP-196




Primary Outcome Measures :
  1. Response based on overall response rate [ Time Frame: Cycle 1 (28 Days) to 6 months ]


Information from the National Library of Medicine

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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:

  • Men and women 18 years of age and older with histologically confirmed disease.
  • Active disease as defined by at least one of the following (IWCLL consensus criteria):

    • Weight loss ≥10% within the previous 6 months
    • Extreme fatigue
    • Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection
    • Night sweats for more than one month without evidence of infection
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
    • Massive or progressive splenomegaly
    • Massive nodes or clusters or progressive lymphadenopathy
    • Progressive lymphocytosis with an increase of >50% over a 2 month period, or an anticipated doubling time of less than 6 months
    • Compensated autoimmune hemolysis
  • Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation
  • Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Exclusion Criteria:

  • Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks.
  • Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function

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): NCT02337829


Locations
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United States, Maryland
Bethesda, Maryland, United States
Sponsors and Collaborators
Acerta Pharma BV
National Institutes of Health (NIH)
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613: acertamc@dlss.com

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02337829     History of Changes
Other Study ID Numbers: 15-H-0016
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: November 2018
Keywords provided by Acerta Pharma BV:
Relapsed/refractory CLL
SLL
Btk
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Leukemia
Lymphoma
Lymphocytic
ACP-196
acalabrutinib
Treatment naive CLL with 17p deletion, TP53 mutation or NOTCH1 mutation
17p deletion
TP53 mutation
NOTCH1 mutation
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