Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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


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

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

- 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.

Inclusion 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, provide they meet the following:

- CD4+ cell count > 350/mm3

- Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 13 months

Safety Issue:


Principal Investigator

John P. Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular