Clinical Trials /

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

NCT02337829

Description:

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

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 15-H-0016
  • NCT ID: NCT02337829

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
acalabrutinibACP-196A
acalabrutinibACP-196A

Purpose

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

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.

Trial Arms

NameTypeDescriptionInterventions
AExperimentalto undergo superficial lymph node biopsies
  • acalabrutinib
  • acalabrutinib
BExperimentalto undergo bone marrow biopsies
  • acalabrutinib
  • acalabrutinib

Eligibility 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/SLL or treatment naïve patients

- 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response based on overall response rate
Time Frame:Cycle 1 (28 Days) to 6 months
Safety Issue:
Description:

Secondary Outcome Measures

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Acerta Pharma BV

Trial Keywords

  • CLL
  • SLL
  • Btk
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Lymphoma
  • Lymphocytic
  • ACP-196
  • acalabrutinib

Last Updated

December 2, 2016