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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acalabrutinib (Arm A)

Acalabrutinib (Arm B)

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Relapsed/refractory CLL, Btk, Leukemia, Lymphocytic, Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), ACP-196, Acalabrutinib, Treatment naive CLL, 17p deletion, TP53 mutation, NOTCH1 mutation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm 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.

Outcomes

Primary Outcome Measures

Response Based on Overall Response Rate

The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.

Secondary Outcome Measures

Full Information

NCT ID

NCT02337829

First Posted

November 19, 2014

Last Updated

July 18, 2023

Sponsor

Acerta Pharma BV

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT02337829

Brief Title

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

Official Title

A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 12, 2015 (Actual)

Primary Completion Date

June 26, 2020 (Actual)

Study Completion Date

May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acerta Pharma BV

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Keywords

Relapsed/refractory CLL, Btk, Leukemia, Lymphocytic, Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), ACP-196, Acalabrutinib, Treatment naive CLL, 17p deletion, TP53 mutation, NOTCH1 mutation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm 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.

Arm Title

Arm B

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Acalabrutinib (Arm A)

Other Intervention Name(s)

ACP-196

Intervention Description

A1a) acalabrutinib, dose A daily: biopsy (T) schedule W; A1b) acalabrutinib, dose A daily: biopsy (T) schedule V. A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y; A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z

Intervention Type

Drug

Intervention Name(s)

Acalabrutinib (Arm B)

Other Intervention Name(s)

ACP-196

Intervention Description

B1c) acalabrutinib, dose A daily: biopsy (U) schedule W; • B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.

Primary Outcome Measure Information:

Title

Response Based on Overall Response Rate

Description

Time Frame

Cycle 1 (28 Days) to 6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca Clinical Study Information Center

Organizational Affiliation

1-877-240-9479 - information.center@astrazeneca.com

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

32202637

Citation

Sun C, Nierman P, Kendall EK, Cheung J, Gulrajani M, Herman SEM, Pleyer C, Ahn IE, Stetler-Stevenson M, Yuan CM, Maric I, Gaglione EM, Harris HM, Pittaluga S, Wang MH, Patel P, Farooqui MZH, Izumi R, Hamdy A, Covey T, Wiestner A. Clinical and biological implications of target occupancy in CLL treated with the BTK inhibitor acalabrutinib. Blood. 2020 Jul 2;136(1):93-105. doi: 10.1182/blood.2019003715.

Results Reference

derived

PubMed Identifier

32054731

Citation

Alsadhan A, Cheung J, Gulrajani M, Gaglione EM, Nierman P, Hamdy A, Izumi R, Bibikova E, Patel P, Sun C, Covey T, Herman SEM, Wiestner A. Pharmacodynamic Analysis of BTK Inhibition in Patients with Chronic Lymphocytic Leukemia Treated with Acalabrutinib. Clin Cancer Res. 2020 Jun 15;26(12):2800-2809. doi: 10.1158/1078-0432.CCR-19-3505. Epub 2020 Feb 13.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=15-H-0016&attachmentIdentifier=e4575fcb-4235-4e46-a0ef-ba83d6d840e2&fileName=15-H-0016-protocol_Redacted.pdf&versionIdentifier=

Description

15-H-0016_Protocol Redacted

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=15-H-0016&attachmentIdentifier=c6643522-782d-4db3-8af9-8823ea068dc4&fileName=15-h-0016-sap-ed-3_Redacted.pdf&versionIdentifier=

Description

15-H-0016_SAP ed.3 Redacted

Learn more about this trial

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

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