Safety and Efficacy of ibrutinib in combination with lenalidomide and rituximab in patients with previously treated Diffuse Large B-Cell Lymphoma
- Conditions
- Relapsed or Refractory Diffuse Large B-Cell LymphomaMedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004341-17-GB
- Lead Sponsor
- Pharmacyclics LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 83
· Pathologically confirmed relapsed/ refractory DLBCL
· Must have previously received first line treatment regimen
· Must be ineligible for high dose therapy/ stem cell transplantation
· Measurable disease sites on CT scan (>1.5 cm in longest dimension)
· PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
· Men and women =18 years of age
· ECOG < 2
· Adequate hepatic and renal function
· Adequate hematologic function
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
· Medically apparent central nervous system lymphoma or leptomeningeal disease
· History of allogeneic stem-cell (or other organ) transplantation
· Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
· Radio- or toxin-immunoconjugates within 10 weeks
· Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method