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

Acerta Pharma

Status and phase: Completed; Phase 2

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Acalabrutinib (Arm B); Drug: Acalabrutinib (Arm A)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02337829

15-H-0016

Details and patient eligibility

About

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

Full description

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Arm A

Experimental group

Description:

Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.

Treatment:

Drug: Acalabrutinib (Arm A)

Drug: Acalabrutinib (Arm B)

Arm B

Experimental group

Description:

Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.

Treatment:

Drug: Acalabrutinib (Arm A)

Drug: Acalabrutinib (Arm B)