Protocol Summary

Protocol No.: OCR13264

Sponsor Protocol No.: PCYC-1123-CA

Study Title
A Multicenter Open-Label Phase 1 b/2 Study of the Brutons Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Principal Investigator(s)
Dang, Nam

Objective
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) not eligible for transplant.

Description
Phase 1b: In the dose escalation portion of the study, up to four cohorts may be explored and lenalidomide dose escalation will follow the 3+3+3 principle for MTD determination.

Phase 2: This will be conducted as an international, multicenter, randomized open-label study. Eligible subjects will be randomized in a 1:1 ratio into 2 arms to receive either ibrutinib, lenalidomide and rituximab (Treatment Arm A) or ibrutinib and lenalidomide (Treatment Arm B).

Phase: Phase I/II

Age Group: Adult

Scope: National

Treatment
Phase 1: Dose Level -1, Level 1, Level 2, Level 3
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)

Phase 2 - Arm A
Ibrutinib PO+ Lenalidomide (PO) + Rituximab (IV)

Phase 2 - Arm B
Ibrutinib PO+ Lenalidomide (PO)


Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years-old and older
2. Pathologically confirmed relapsed/ refractory DLBCL
3. Must have previously received first line treatment regimen
4. Must be ineligible for high dose therapy/ stem cell transplantation
5. Measurable disease sites on CT scan (>1.5 cm in longest dimension)
6. PT/INR 7. Men and women >=18 years of age
8. ECOG - Adequate hepatic and renal function:
- AST or ALT = - Creatinine clearance (Cockcroft-Gault or 24-hour creatinine clearance collection) >60 mL/min.
9. Adequate hematologic function:
- ANC >1.50 cells/mm3
- Plt >75,000 cells/mm3
- Hgb >8.0 g/dL

EXCLUSION CRITERIA:
1. Medically apparent central nervous system lymphoma or leptomeningeal disease
2. History of allogeneic stem-cell (or other organ) transplantation
3. Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
4. Radio- or toxin-immunoconjugates within 10 weeks
5. Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

Applicable Disease Sites
Lymphoma - Non-Hodgkin

Participating Institutions
UF Gainesville : Ashton Monismith

Contact
Ashton Monismith, RN
Phone: +1 352-265-0680 ext. 87657

Email: amonismith@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02077166