Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

NCT ID: NCT01980654

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-11-30

Brief Summary

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).

Detailed Description

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with FL.

There are two study treatment arms.

Subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.

Subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.

Conditions

Follicular Lymphoma; B-cell Lymphoma; Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main Study Arm 1

Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

All subjects will receive 560 mg of Ibrutinib orally.

rituximab

Intervention Type: DRUG

All subjects will receive rituximab 375 mg/m2 intravenously

Exploratory Study Arm 2

Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

All subjects will receive 560 mg of Ibrutinib orally.

rituximab

Intervention Type: DRUG

All subjects will receive rituximab 375 mg/m2 intravenously

Interventions

Ibrutinib

All subjects will receive 560 mg of Ibrutinib orally.

Intervention Type: DRUG

rituximab

All subjects will receive rituximab 375 mg/m2 intravenously

Intervention Type: DRUG

Other Intervention Names

PCI-32765; Rituxan

Eligibility Criteria

Inclusion Criteria

1. Histologically documented FL (Grade 1, 2 and 3A)

2. Not previously treated with prior anti-cancer therapy for FL

3. Stage II, III or IV disease

4. At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan

5. Men and women ≥ 18 years of age

6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria

1. Medically apparent central nervous system lymphoma or leptomeningeal disease

2. FL with evidence of large cell transformation

3. Any prior history of other hematologic malignancy besides FL or myelodysplasia

4. History of other malignancies, except

1. Malignancy treated with curative intent and with no known active disease present for ≥5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.

2. Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease.

3. Adequately treated carcinoma in situ without evidence of disease.

5. Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening

6. Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab (Rituxan®)

7. Requires anti-coagulation with warfarin or a vitamin K antagonist.

8. Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.

9. Known bleeding diathesis or hemophilia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jutta K. Neuenburg, MD, PhD

Role: STUDY_DIRECTOR

Pharmacyclics LLC.

Locations

Providence Saint Joseph Medical Center

Burbank, California, United States

City of Hope

Duarte, California, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford University, Stanford Care Center

Stanford, California, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Community Health Network Community Regional Cancer Center North

Indianapolis, Indiana, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College New York-Presbyterian Hospital

New York, New York, United States

Mid-Ohio Oncology/ Hematology Inc

Columbus, Ohio, United States

Tennessee Oncology, PLLC The Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PCYC-1125-CA

Identifier Type: -

Identifier Source: org_study_id