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Lenalidomide, Rituximab, and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Alliance for Clinical Trials in Oncology
Gilead Sciences
Celgene Corporation
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: July 17, 2012
Last updated: September 16, 2013
Last verified: August 2013

Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase I trial studies the side effects and the best dose of lenalidomide when giving together with rituximab and idelalisib in treating patients with recurrent follicular lymphoma.

Condition Intervention Phase
Biological: rituximab
Drug: idelalisib
Drug: lenalidomide
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Lenalidomide, Rituximab and Idelalisib in Recurrent Follicular Lymphoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • MTD based on the incidence of dose-limiting toxicity (DLT) assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • OR rate assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • CR rate assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • PFS assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide, rituximab and idelalisib


Lenalidomide will be administered orally on days 1-20 followed by 7 days of rest, every 28 days. A treatment cycle will be considered 28 days in length. In the absence of intolerable toxicity or disease progression, lenalidomide will be given for a total of 12 cycles.


Dosing is fixed in all cohorts receiving idelalisib at 150 mg orally (twice daily) for 12 cycles, with the exception of dose modifications for toxicity.


Rituximab 375 mg/m2 will be administered by intravenous (IV) infusion during cycle 1 on days 8,15, 22, and on day 1 of cycle 2 (a total of four doses) for all dose level cohorts.

Biological: rituximab
Rituximab 375 mg/m2 will be administered by intravenous (IV) infusion.
Drug: idelalisib
Idelalisib will be administered orally (twice daily) at 150 mg.
Drug: lenalidomide
Lenalidomide will be administered orally.

Detailed Description:


This is a multicenter, dose-escalation study of lenalidomide.

Patients receive lenalidomide orally (PO) on days 1-21; rituximab intravenously (IV) on days 8, 15, and 22 of course 1 and on day 1 of course 2; and idelalisib twice daily (BID) on days 1-28. Treatment with lenalidomide and idelalisib repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. The primary and secondary objectives of the study include the following:

Primary Objective:

  • To determine the maximum-tolerated dose (MTD) of lenalidomide when combined with rituximab and idelalisib in patients with recurrent follicular non-Hodgkin lymphoma (NHL).

Secondary Objectives:

  • To determine the toxicity profile of lenalidomide, rituximab, and idelalisib therapy in patients with recurrent follicular NHL.
  • To estimate the efficacy (overall response [OR] rate, complete response [CR] rate, and progression-free survival [PFS]) of lenalidomide, rituximab, and idelalisib in patients with recurrent follicular NHL in a preliminary fashion (using a small extension cohort).
  • To assess whether the therapeutic effects of the lenalidomide, rituximab, and idelalisib combination are sufficiently promising to warrant evaluation in a subsequent (phase II/III) randomized trial (in comparison to the two-drug regimen of lenalidomide plus rituximab, or another standard regimen).

After completion of study treatment, patients are followed up at 2, 4, 6, 9, 12, 15, 18, and 24 months and then yearly for 10 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • Documentation of Disease

    • Previously treated, histologically confirmed follicle center cell lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes present)
    • Bone marrow biopsies as the sole means of diagnosis are not acceptable; fine-needle aspirates are not acceptable for diagnosis
    • Confirmed Cluster of Differentiation 20 (CD20) antigen expression by flow cytometry or immunohistochemistry
  • Measurable disease must be > 1 cm
  • Prior treatment

    • Patient must have had prior treatment with rituximab either alone or in combination with chemotherapy.
    • Last prior treatment regimen need not include rituximab.
    • Patient must have a time to progression of ≥ 6 months from last rituximab dose of last rituximab containing regimen.
    • No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
  • Patients must be 18 years of age or older.
  • Human immunodeficiency virus (HIV) Infection

    • Patients with HIV infection are eligible, provide they meet the following:
    • CD4+ cell count > 350/mm3
    • Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm3
    • No history of Acquired Immunodeficiency Syndrome (AIDS)-defining conditions or other HIV related illness
    • No concurrent zidovudine or stavudine because of overlapping toxicities with protocol therapy
  • Patients must not have known central nervous system (CNS) involvement
  • Patients must not have known positivity for hepatitis B or C
  • Patients must not have any currently active secondary malignancy except non-melanoma skin cancer
  • Patients must not have had deep vein thrombosis or pulmonary embolism within the past 3 months.
  • Patients must not have had radioimmunotherapy within 12 months of study entry.
  • Patients must not have other concurrent investigational or commercial agents or therapies for lymphoma.
  • Patients must not have current dialysis treatment.
  • Patients must be non-pregnant and non-nursing.
  • CYP3A4 Strong Inducers and Inhibitors

    • Patients must not be on strong CYP3A4 inhibitors and/or inducers.
    • Strong CYP3A4 Inhibitors prohibited are indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone
    • Strong CYP3A4 Inducers prohibited are carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort, troglitazone
  • Required Initial Laboratory Values

    • Absolute neutrophil count (ANC) ≥ 1,000 mm³
    • Total Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert disease or lymphoma)
    • Creatinine ≤ 1.5 times ULN (unless due to lymphoma) OR creatinine clearance (CrCl) ≤ 60 mL/minute
    • Platelet count ≥ 75,000 mm³
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2 x ULN
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01644799

United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Bruce Cheson    202-444-7932      
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Sonali Smith    773-702-9251      
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Nancy Bartlett, M.D.    314-362-5654      
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: John Leonard    646-962-2068      
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Steven Park, M.D.    919-966-4432 ext 236      
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Beth Christian, M.D.    614-293-3196      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Gilead Sciences
Celgene Corporation
Principal Investigator: John P. Leonard, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01644799     History of Changes
Other Study ID Numbers: A051202, CDR0000736814, NCI-2012-01988, U10CA031946
Study First Received: July 17, 2012
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on July 20, 2014