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Recurrent Follicular LymphomaPhase 1NCT01644799

Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

A Phase 1 study testing idelalisib and lenalidomide in people with Recurrent Follicular Lymphoma, run by Alliance for Clinical Trials in Oncology at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Follicular Lymphoma
What is being tested?
idelalisib and lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
6 sitesUnited States
Study dates
2 Aug 2013to May 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
idelalisib, lenalidomide
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01644799
Study groupRoleWhat they receive
lenalidomide and idelalisibExperimentalLenalidomide: 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.
Receives: Drug: idelalisib; Drug: lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 13 months

Secondary outcomes (4)

  1. Toxicity profile assessed by NCI CTCAE version 4.0

    Measured: Up to 10 years

  2. OR rate assessed up to 10 years

    Measured: Up to 10 years

  3. CR rate assessed up to 10 years

    Measured: Up to 10 years

  4. PFS assessed up to 10 years

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study start2 Aug 2013
  3. Primary completionAug 2014
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644799
Sponsor's protocol ID
A051202
Other IDs
CDR0000736814, NCI-2012-01988, U10CA031946
Status last verified
Jun 2026
First submitted
17 Jul 2012
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No

Publications

  • Smith SM, Pitcher BN, Jung SH, Bartlett NL, Wagner-Johnston N, Park SI, Richards KL, Cashen AF, Jaslowski A, Smith SE, Cheson BD, Hsi E, Leonard JP. Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials. Lancet Haematol. 2017 Apr;4(4):e176-e182. doi: 10.1016/S2352-3026(17)30028-5. Epub 2017 Mar 15.

    PubMed 28314699

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing idelalisib and lenalidomide in people with Recurrent Follicular Lymphoma, run by Alliance for Clinical Trials in Oncology at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: Up to 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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