EUCTR2015-005317-68-ES
Active, not recruiting
Phase 1
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy - ACE-CL-208
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- High Risk Chronic Lymphocytic Leukemia
- Sponsor
- Acerta Pharma, BV
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\-Prior diagnosis of CLL that meets published diagnostic criteria (Hallek 2008\)
- •2\-Must have received ? 1 prior therapy for CLL and not be appropriate for treatment or retreatment with purine analogue\-based therapy
- •3\-Intolerant of ibrutinib, defined as the subject has discontinued ibrutinib therapy due to Grade 3 or 4 AEs that persisted in spite of optimal supportive care measures OR patients who had Grade 2 AEs related to ibrutinib therapy, in spite of optimal supportive care measures, that persisted for ? 2 weeks or that recurred ? 2 times whether dose was reduced or discontinued.
- •4\-ECOG performance status of ? 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 40
Exclusion Criteria
- •1\-Ongoing Grade 3 or 4 AE attributed to ibrutinib therapy. Note: Patients may be eligible for enrollment once the ibrutinib\-related AE improves to Grade ? 2\.
- •2\-Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
- •3\-Prior exposure to a BCL\-2 inhibitor (eg, ABT\-199\).
- •4\-Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ? 2 years.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib TherapyHigh Risk Chronic Lymphocytic LeukemiaMedDRA version: 20.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-005317-68-BEAcerta Pharma, BV60
Active, not recruiting
Phase 1
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib TherapyHigh Risk Chronic Lymphocytic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-005317-68-GBAcerta Pharma B.V.60
Active, not recruiting
Phase 1
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib TherapyHigh Risk Chronic Lymphocytic LeukemiaMedDRA version: 19.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-005317-68-FRAcerta Pharma, BV80
Completed
Not Applicable
Acupuncture and Analgesics against Cancer Pain in Advanced Cancer PatientsKCT0001897Dankook University30
Completed
Phase 3
A study on the role of traditional drug based dressings in the treatment of skin wounds produced in breast cancer patients undergoing radiotherapyHealth Condition 1: C508- Malignant neoplasm of overlappingsites of breastCTRI/2020/11/029311I110