A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Phase 1

• Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; MedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000600-15-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 580

Inclusion Criteria

- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
-Active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment
- Measurable nodal disease by computed tomography
- Relapsed or refractory CLL following at least 1 prior line of systemic therapy consisting of at least 2 cycles of a chemotherapy-containing regimen
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1
- Hematology and biochemical values within protocol-defined limits within 7 days prior to
randomization
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 174
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 406

Exclusion Criteria

- Recent therapeutic interventions within 3 (chemotherapy/radiotherapy) to 10 weeks (immunotherapy)
- Prior treatment with ibrutinib or other Bruton´s tyrosine kinase inhibitors or prior randomization in any other clinical study evaluating ibrutinib
- The presence of deletion of the short arm of chromosome 17
- Patients previously treated with a bendamustine-containing regimen who did not achieve a response or who relapsed within 24 months of treatment with that regimen
- Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant - Received a hematopoietic stem cell transplant
- Known central nervous system leukemia/lymphoma or Richter´s transformation - Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Chronic use of corticosteroids
- History of prior malignancy, except: malignancy treated with curative intent and with no
known active disease present for >=3 years before randomization; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
- History of stroke or intracranial hemorrhage within 6 months prior to randomization; or clinically significant cardiovascular disease
- Requires anticoagulation with warfarin or
treatment with strong CYP3A4/5 or CYP2D6 inhibitors

Study & Design

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