Trial record 1 of 1 for:    A051202
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Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
Gilead Sciences
Celgene Corporation
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01644799
First received: July 17, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Follicular Lymphoma
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 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: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  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 ClinicalTrials.gov identifier: NCT01644799

Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01644799     History of Changes
Other Study ID Numbers: A051202, CDR0000736814, NCI-2012-01988, U10CA031946
Study First Received: July 17, 2012
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

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
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014