A Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia with the 17p Deletio

Phase 1

Active, not recruiting

• Conditions: Chronic Lymphocytic Leukemia 17 p Deletion; MedDRA version: 18.0Level: LLTClassification code 10024340Term: Leukemia lymphocytic chronicSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004027-20-FR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-16
• Last Update Posted: 2021-01-18

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subject must be = 18 years of age
2. Subject must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG criteria.
• Subject has an indication for treatment according to the 2008 IWCLL NCI-WG criteria;
• Subject has clinically measurable disease;
• Subject must have relapsed or be refractory after receiving at least one prior line of therapy (a line of therapy is defined as completing at least 2 cycles of treatment for a given line of therapy);
• Subjects must have 17p deletion, assessed by central laboratory, and determined by FISH using the Vysis CLL probe kit.
3. Subject has an ECOG performance score of = 2
4. Subjects must meet the following laboratory parameters, per laboratory reference range: ANC = 1000/µL-For subjects with an ANC < 1000/µL at Screening and bone marrow heavily infiltrated with underlying disease (approximately 80% or more), G-CSF may be administered after Screening and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria (= 1000/µL); Platelet count > 40,000 mm3, (independent of
transfusion within 14 days of screening); aPTT and PT = 1.5 × ULN; Hemoglobin = 8.0 g/dL; AST and ALT = 3 × ULN; Calculated creatinine clearance> 50 mL/min; Total bilirubin = 1.5 × ULN (Subjects with Gilbert's Syndrome may have bilirubin > 1.5 × ULN with the approval of the Abbott medical monitor).
5. For high risk subjects (as defined in Section 6.7.1) a pre approval by the AbbVie medical monitor is required prior to enrollment.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Subject has undergone an allogeneic stem cell transplant or has developed Richter's transformation.
2. Subject has received a biologic agent (i.e. monoclonal antibodies) for anti-neoplastic intent within 8 weeks prior to the first dose of study drug. Subject has received any anti-cancer therapy including chemotherapy, or radiotherapy; Investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug, or has not recovered to less than CTC grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
3. Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. For subjects who have required an intervention for any above diseases within the past 6 months a discussion with the investigator and the AbbVie medical monitor must occur. 4. Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal).
5. History of other active malignancies other than CLL within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
6. Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
7. Subject has tested positive for HIV due to potential drug-drug interactions as well as anticipated mechanism-based lymphopenia that may increase the risk of
opportunistic infections.
8. Cardiovascular disability status of New York Heart Association Class =2.
9.Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified