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Alkylating Agent

lenalidomide for Marginal Zone Lymphoma

Phase 1 & 2

Waitlist Available

Led By Sonali Smith

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For purposes of this trial, prednisone or other corticosteroids used for non-lymphomatous conditions will be allowed.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time elapsed between treatment initiation and tumor progression or death from any cause (whichever occurs first), assessed up to 3 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of lenalidomide when given with chemotherapy to treat patients with MYC-associated B-cell lymphomas. Lenalidomide works by blocking growth of new blood vessels and enzymes needed for cell growth. Chemo drugs work in different ways to stop cancer cell growth. Monoclonal antibodies may also block cancer growth.

Eligible Conditions

Marginal Zone Lymphoma
Diffuse Mixed Cell Lymphoma
Intraocular Lymphoma
Lymphomatoid Granulomatosis
Chronic Lymphocytic Leukemia
Adult Diffuse Large Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Immunoblastic Large Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Lymphoma
B-Cell Non-Hodgkin Lymphoma
MALT Lymphoma
Nodal Marginal Zone Lymphoma
Non-Contiguous Diffuse Large B-Cell Lymphoma
Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Adult Diffuse Mixed Cell Lymphoma
Adult Diffuse Small Cleaved Cell Lymphoma
Hodgkin's Lymphoma
Diffuse Large Cell Lymphoma
Testicular Lymphoma
Waldenström's Macroglobulinemia
Non-Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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If you are currently taking prednisone or other corticosteroids for a condition that is not related to lymphoma, you can still participate in the trial.

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You can still participate if you had radiation therapy in the past to reduce pain or improve neurological symptoms, as long as there are still areas of the disease that can be measured.

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If you recently took a short course of steroids (less than 2 weeks) to help relieve symptoms of lymphoma, you can still participate.

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You are able to take a low dose of aspirin every day to prevent blood clots. If you can't take aspirin, you may be allowed to take warfarin or low molecular weight heparin instead.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time elapsed between treatment initiation and tumor progression or death from any cause (whichever occurs first), assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time elapsed between treatment initiation and tumor progression or death from any cause (whichever occurs first), assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time elapsed between treatment initiation and tumor progression or death from any cause (whichever occurs first), assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MTD of adding lenalidomide to the DA-EPOCH-R regimen as a front-line therapy in patients with DHL lymphomas (using CTCAE v 4.0) (Phase I)

PFS

PFS (Phase II)

Secondary outcome measures

Add lenalidomide to the DA-EPOCH-R regimen as a front-line therapy in patients with DHL lymphomas (Phase I)

Chromium

Duration of response, calculated as the duration from detecting any objective response until progression or death from any cause, according to the Revised Response Criteria for Malignant Lymphoma and Cheson et al (Phase I)

+2 more

Side effects data

From 2012 Phase 3 trial • 198 Patients • NCT00064038

78%

Hemoglobin

78%

Fatigue (asthenia, lethargy, malaise)

55%

Glucose, serum-high (hyperglycemia)

50%

Leukocytes (total WBC)

48%

Constipation

48%

Calcium, serum-low (hypocalcemia)

45%

Potassium, serum-low (hypokalemia)

40%

Platelets

40%

Lymphopenia

38%

Neutrophils/granulocytes (ANC/AGC)

33%

Edema: limb

33%

Albumin, serum-low (hypoalbuminemia)

33%

Pain - Back

30%

Pain - Joint

30%

Creatinine

28%

Nausea

28%

Rash/desquamation

28%

Anorexia

25%

Pain - Muscle

23%

Diarrhea

23%

Mood alteration - depression

23%

Neuropathy: sensory

20%

Pain - Bone

20%

Dizziness

20%

Insomnia

20%

Sodium, serum-low (hyponatremia)

18%

Aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT)

18%

Dehydration

15%

Thrombosis/thrombus/embolism

15%

Pain - Extremity-limb

13%

Pain - Head/headache

13%

Mucositis/stomatitis (clinical exam) - Oral cavity

13%

Taste alteration (dysgeusia)

13%

Phosphate, serum-low (hypophosphatemia)

13%

Inf w/normal ANC or Gr 1-2 neutrophils - Up airway

13%

Vision-blurred vision

13%

Muscle weakness, not d/t neuropathy - body/general

13%

Cough

10%

Rash: acne/acneiform

10%

Weight gain

10%

Inf w/normal ANC or Gr 1-2 neutrophils - UTI

10%

Neuropathy: motor

10%

Bilirubin (hyperbilirubinemia)

10%

Alkaline phosphatase

10%

Alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT)

10%

Muscle weakness, not d/t neuropathy - Extrem-lower

Pain - Chest/thorax NOS

Pain-Other (Specify)

Glucose, serum-low (hypoglycemia)

Musculoskeletal/Soft Tissue-Other (Specify)

Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Bronchus

Cataract

Pain - Abdomen, not otherwise specified (NOS)

Pain - Dental/teeth/peridontal

Weight loss

Fever in absence of neutropenia, ANC lt1.0x10e9/L

Proteinuria

Metabolic/Laboratory-Other (Specify)

Rigors/chills

Hot flashes/flushes

Osteonecrosis (avascular necrosis)

Infection with unknown ANC - Skin (cellulitis)

Memory impairment

Tremor

Confusion

Sweating (diaphoresis)

Pain - Neck

Mood alteration - agitation

Infection with unknown ANC - Sinus

Ocular/Visual-Other (Specify)

Inf w/normal ANC or Gr 1-2 neutrophils - Skin

Dyspnea (shortness of breath)

Flushing

Inf w/normal ANC or Gr 1-2 neutrophils - Sinus

Hemorrhage, pulmonary/upper respiratory - Nose

Central nervous system (CNS) cerebrovascular ischemia

Renal failure

Heartburn/dyspepsia

Infection with unknown ANC - Urinary tract NOS

Bruising (in absence of Gr 3-4 thrombocytopenia)

Calcium, serum-high (hypercalcemia)

Magnesium, serum-low (hypomagnesemia)

Potassium, serum-high (hyperkalemia)

Triglyceride, serum-high (hypertriglyceridemia)

Arthritis (non-septic)

Incontinence, urinary

Pain - Bladder

Dermatology/Skin-Other (Specify)

Photosensitivity

Ulceration

Hypertension

Left ventricular diastolic dysfunction

Colitis

Syncope (fainting)

Pneumonitis/pulmonary infiltrates

Gastritis (including bile reflux gastritis)

Obstruction, GI - Colon

Death - Disease progression, not otherwise specified (NOS)

Encephalopathy

Somnolence/depressed level of consciousness

Speech impairment (e.g., dysphasia or aphasia)

Glomerular filtration rate

SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT)

100%

80%

60%

40%

20%

Study treatment Arm

Crossover to Rev+Dex

Lenalidomide and Dexamethasone

Dexamethasone

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, DA-EPOCH-R)Experimental Treatment9 Interventions

INDUCTION 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

FDA approved

Lenalidomide

FDA approved

Etoposide

FDA approved

Sulfate ion

Not yet FDA approved

Doxorubicin

FDA approved

Cyclophosphamide

FDA approved

Rituximab

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,703 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,443 Total Patients Enrolled

Sonali SmithPrincipal InvestigatorUniversity of Chicago

5 Previous Clinical Trials

307 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common indications for lenalidomide?

"lenalidomide is most often used to combat merkel cell cancer; however, it has also shown efficacy in treating ophthalmia, leukemia, sympathetic. To be eligible for this treatment lenalidomide patients must have already tried at least two other systemic chemotherapy regimens."

Answered by AI

Could you tell me how many different centers are responsible for this clinical trial?

"There are 6 sites currently enrolling for this study, which include NorthShore University HealthSystem in Evanston, Rush University Medical Center in Baltimore, and University of Maryland in Decatur."

Answered by AI

Can you share any other research that has been done on lenalidomide?

"As of now, 1839 clinical trials related to lenalidomide are ongoing. 404 of these active studies are in their third and final Phase. The majority of these trials for lenalidomide originate from Mishawaka, Indiana; although, there are 70563 locations worldwide currently running tests for this treatment."

Answered by AI

Are recruitment efforts for this clinical trial still underway?

"According to the latest data from clinicaltrials.gov, this particular trial is no longer recruiting patients. This specific study was first posted on 7/29/2014 and updated as recently as 10/8/2021; however, there are 4886 other trials that remain active."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2014. "Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02213913.

All > Lenalidomide > Revlimid