Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

January 26, 2018 updated by: Alliance for Clinical Trials in Oncology

A Phase I Trial of Lenalidomide and Idelalisib in Recurrent Follicular Lymphoma

Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. 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 idelalisib in treating patients with recurrent follicular lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

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

Patients receive lenalidomide orally (PO) on days 1-21 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 idelalisib in patients with recurrent follicular non-Hodgkin lymphoma (NHL).

Secondary Objectives:

  • To determine the toxicity profile of lenalidomide and idelalisib therapy in patients with recurrent follicular NHL
  • To estimate the efficacy (overall response rate [ORR], complete response rate [CRR], and progression-free survival [PFS]) of lenalidomide 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 and idelalisib combination are sufficiently promising to warrant evaluation in a subsequent (phase II/III) randomized trial

After completion of study treatment, patients are followed at 2, 4, 6, 9, 12, 15, 18, and 24 months and then annually. Patients are followed once every year for a maximum of 10 years from study entry.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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, provided they meet the following:
    • CD4+ cell count > 350/mm^3
    • Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm^3
    • 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, as evidenced by + HBsAG or anti-HBc and must not have known history of hepatitis C
  • Patients must not have any currently active secondary malignancy except non-melanoma skin cancer. Patients are not considered to have a "currently active" secondary malignancy if they have completed anticancer therapy and are deemed to have < 30% risk of relapse by their physician.
  • 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.

    • Females of Child Bearing Potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (eg, has had menses at any time preceding 24 consecutive months)
    • FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to registration

    • FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control

      • One highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide
      • FCBP must also agree to ongoing pregnancy testing
    • Men must agree to use a latex condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy

  • CYP3A4 Strong Inducers and Inhibitors

    • Patients must not be on strong CYP3A4 inhibitors and/or inducers.
    • Strong inhibitors are prohibited: indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone
    • Strong inducers are prohibited: 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lenalidomide and idelalisib

Lenalidomide:

Lenalidomide will be administered orally on days 1-21 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.

Idelalisib:

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.
Drug: idelalisib
oral
Drug: lenalidomide
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 13 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity profile assessed by NCI CTCAE version 4.0
Time Frame: Up to 10 years
Up to 10 years
OR rate assessed up to 10 years
Time Frame: Up to 10 years
Up to 10 years
CR rate assessed up to 10 years
Time Frame: Up to 10 years
Up to 10 years
PFS assessed up to 10 years
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)
Gilead Sciences
Celgene Corporation

Investigators

  • Principal Investigator: John P. Leonard, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A051202
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000736814 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2012-01988 (Registry Identifier: CTRP (Clinical Trials Reporting System))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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