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Adult Grade III Lymphomatoid GranulomatosisPhase 1/2NCT02213913

Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas

A Phase 1/2 study testing lenalidomide, etoposide and prednisone in people with Adult Grade III Lymphomatoid Granulomatosis and B-cell Chronic Lymphocytic Leukemia, run by University of Chicago 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

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)-associated B-cell lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide, etoposide and prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
6 sitesUnited States
Study dates
29 Jul 2014to 29 Oct 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • B-cell lymphoma with comprehensive immunohistochemistry (IHC) panel establishing lineage (CD20, CD3) and cell of origin (CD10, BCL6 and MUM1) in addition to proliferative/prognostic markers (Ki-67, C-myc and BCL2). DHL will be identified using cytogenetics and/or immunohistochemistry as detailed in section 4.1.2 below.
  • To define DHL, patients must have evidence of C-myc [defined as: Cytogenetic evidence (FISH or karyotype) of C-myc breaks (Increased copy number in itself is not considered positivity for C-myc) OR Positive IHC defined as >40% of the lymphoma cells staining for C-myc] PLUS either:
  • Breaks in BCL-2 via cytogenetic studies or
  • BCL-2 immunopositivity in >70% of lymphoma cells.
  • Patients are allowed to have received radiotherapy before enrollment if radiation was given to alleviate pain and/or neurologic compromise as long as there remains areas of measurable disease present. Further, at the investigator's discretion and for patients who are unstable, one cycle of R-CHOP is allowed prior to enrollment but no more than one cycle. For purposes of this trial, prednisone or other corticosteroids used for non-lymphomatous conditions will be allowed. In addition, a prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms will be allowed.
  • AST and ALT < 3 x upper limit of normal (ULN), and total bilirubin <1.5 x ULN (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment).
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  • Patients must have adequate renal function by virtue of GFR > 50 ml/minute using Cockroft-Gault formula.
  • Patients must have adequate bone marrow function (platelets >100,000 and ANC >1,200). Patients with bone marrow involvement are allowed at the investigator's discretion regardless of cytopenias.
  • ECOG PS 0-2.
  • Age ≥ 18 years.
  • All study participants must be registered into the mandatory lenalidomide REMS® program, and be willing and able to comply with the requirements of the REMS® program.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the lenalidomide REMS® program. (Please see study schema for further details)
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
  • Ability to read, understand, and sign a written informed consent approved by each institutional IRB. Alternatively, patients with legal guardians who can read, understand, and sign written informed consent may also enroll.

Who cannot join

  • Prior therapy for lymphoma
  • Known CNS involvement
  • Known HIV positive status
  • Pregnant females
  • Burkitt and/or precursor lymphoblastic leukemia/lymphoma.
  • Prior pomalidomide exposure
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  • Known hypersensitivity to lenalidomide or thalidomide
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Subjects who have currently active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment).
  • Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study for NHL or any other illness (except observational, prevention, and/or registry trials).
  • No current malignancy. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (any site) are eligible. Women with a history of cervical cancers are allowed.
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
  • History of significant cerebrovascular disease in the past 3 months or ongoing event with active symptoms or sequelae.
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive, the subject will be excluded if unable to tolerate and/or receive anti-Hepatitis-B therapy. Positive serology because of prior vaccination is allowed.
  • Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
  • Inability to comply with study or follow-up testing and procedures.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Maryland

    Baltimore, Maryland, 21202

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Illinois Cancer Care

    Peoria, Illinois, 61615

Other trials in United States

About this study

Official title: Prospective, Multi-center Phase I/II Trial of Lenalidomide and Dose-Adjusted EPOCH-R in MYC-Associated B-Cell Lymphomas

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with v-myc myelocytomatosis viral oncogene homolog (avian) (MYC)-associated B-cell lymphomas. Lenalidomide may stop the growth of B-cell lymphomas by blocking the growth of new blood vessels necessary for cancer growth and by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving lenalidomide together with combination chemotherapy may be an effective treatment in patients with B-cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) of lenalidomide when added to dose-adjusted (DA)-etoposide, prednisone, vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, rituximab (EPOCH-R) (hereby termed "DA-EPOCH-RR") in patients with double hit lymphoma (DHL) lymphomas. (Phase I) II. To determine the 1- and 2-year progression free survival (PFS) of DA-EPOCH-RR in patients with DHL lymphomas. (Phase II)

SECONDARY OBJECTIVES:

  1. Overall response rate, complete response, and duration of response. II. Quality of life (QOL) measures using standardized scales. III. Toxicity assessment using version 4.0 of the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) criteria.

IV. Overall survival (OS) at 1 and 2 years.

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

INDUCTION PHASE: Patients receive lenalidomide orally (PO) daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

DA-EPOCH-R: Patients receive etoposide intravenously (IV) continuously on days 1-4, prednisone PO twice daily (BID) on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION PHASE: Patients who are transplantation (hematopoietic stem cell transplant [HSCT])-eligible receive BCNU, etoposide, cytarabine, and melphalan (BEAM)-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.

After completion of study treatment, patients are followed up for every 3 months for 1 year, every 4 months for 1 year, and then periodically for 1 year.

Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Follicular

What participants receive

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

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given PO

  • vincristine sulfateDrug

    Also called leurocristine sulfate, VCR, Vincasar PFS

    Given IV

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02213913
Study groupRoleWhat they receive
Treatment (lenalidomide, DA-EPOCH-R)ExperimentalINDUCTION PHASE: Patients receive lenalidomide PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
Receives: Drug: lenalidomide; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Drug: doxorubicin hydrochloride; Drug: cyclophosphamide; Biological: rituximab; Other: quality-of-life assessment; Other: laboratory biomarker analysis

What is being measured

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

  1. Dose-limiting Toxicity (Phase I)

    Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management

    Measured: Up to 21 days

  2. Progression-free Survival

    Time elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.

    Measured: Assessed up to 5 years

  3. Progression-free Survival at 1 Year

    The percentage of patients alive and progression-free at 1 year.

    Measured: 1 year

  4. Progression-free Survival at 2 Years

    Percentage of patients alive and progression-free at 2 years.

    Measured: 2 years

Secondary outcomes (4)

  1. Progression-free Survival at 18 Weeks

    Percentage of patients alive and progression-free at 18 weeks.

    Measured: 18 weeks

  2. Overall Response Rate

    Partial response (PR) or complete response (CR) by computed tomography (CT) of positron emission tomography/CT and/or resolution of marrow-only involvement (if originally involved), according to the Revised Response Criteria for Malignant Lymphoma and Cheson et al.

    Measured: Up to 18 weeks

  3. Anti-tumor Activity

    Stable disease (SD), PR, or CR by computed tomography (CT) of positron emission tomography/CT and/or resolution of marrow-only involvement (if originally involved)according to the Revised Response Criteria for Malignant Lymphoma and Cheson et al.

    Measured: Up to 18 weeks

  4. Duration of Response (Rate at 2 Years)

    Percentage of responding patients alive and progression free two years later.

    Measured: 2 years

Timeline

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

  1. First posted12 Aug 2014 (estimated)
  2. Study start29 Jul 2014
  3. Primary completion1 Oct 2024
  4. Study completion29 Oct 2024

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213913
Sponsor's protocol ID
13-1406
Other IDs
NCI-2014-01581, IRB13-1406, 13-1406, P30CA014599
Status last verified
Mar 2026
First submitted
5 Aug 2014
Last updated
11 Mar 2026
Data monitoring committee
Yes

Publications

  • Cahill K, Godfrey J, Nabhan C, Kline J, Riedell PA, Cohen KS, Narula S, Karrison TG, Robertson J, Karmali R, Venugopal P, Kim SH, Rapoport AP, Lee ST, Law J, Fishkin PAS, Isufi I, Velasco M, Kaminer L, Smith SM. A multicenter phase 1/2 trial of lenalidomide and dose-adjusted EPOCH-R in MYC-associated DLBCL. Blood Adv. 2025 Nov 11;9(21):5665-5675. doi: 10.1182/bloodadvances.2025017092.

    PubMed 40720747

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lenalidomide, etoposide and prednisone in people with Adult Grade III Lymphomatoid Granulomatosis and B-cell Chronic Lymphocytic Leukemia, run by University of Chicago 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?

The sponsor lists 14 inclusion and 16 exclusion criteria. 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 11 Mar 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose-limiting Toxicity (Phase I) (time frame: Up to 21 days). The study lists 4 primary outcomes in all. 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 NCT02213913, 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 11 Mar 2026.

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