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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
Be older than 18 years old
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

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
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
8%
Glucose, serum-low (hypoglycemia)
8%
Pain - Chest/thorax NOS
8%
Pain-Other (Specify)
8%
Musculoskeletal/Soft Tissue-Other (Specify)
8%
Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Bronchus
8%
Cataract
8%
Pain - Abdomen, not otherwise specified (NOS)
8%
Pain - Dental/teeth/peridontal
8%
Weight loss
8%
Fever in absence of neutropenia, ANC lt1.0x10e9/L
8%
Proteinuria
5%
Osteonecrosis (avascular necrosis)
5%
Sweating (diaphoresis)
5%
Confusion
5%
Metabolic/Laboratory-Other (Specify)
5%
Rigors/chills
5%
Hot flashes/flushes
5%
Infection with unknown ANC - Skin (cellulitis)
5%
Memory impairment
5%
Tremor
5%
Pain - Neck
5%
Mood alteration - agitation
5%
Infection with unknown ANC - Sinus
5%
Ocular/Visual-Other (Specify)
5%
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
5%
Dyspnea (shortness of breath)
5%
Flushing
5%
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
5%
Hemorrhage, pulmonary/upper respiratory - Nose
5%
Central nervous system (CNS) cerebrovascular ischemia
5%
Renal failure
5%
Heartburn/dyspepsia
5%
Infection with unknown ANC - Urinary tract NOS
5%
Bruising (in absence of Gr 3-4 thrombocytopenia)
5%
Calcium, serum-high (hypercalcemia)
5%
Magnesium, serum-low (hypomagnesemia)
5%
Potassium, serum-high (hyperkalemia)
5%
Triglyceride, serum-high (hypertriglyceridemia)
5%
Arthritis (non-septic)
5%
Incontinence, urinary
5%
Pain - Bladder
5%
Dermatology/Skin-Other (Specify)
5%
Photosensitivity
5%
Ulceration
5%
Hypertension
3%
Left ventricular diastolic dysfunction
3%
Colitis
3%
Syncope (fainting)
3%
Pneumonitis/pulmonary infiltrates
3%
Gastritis (including bile reflux gastritis)
3%
Obstruction, GI - Colon
3%
Death - Disease progression, not otherwise specified (NOS)
3%
Encephalopathy
3%
Somnolence/depressed level of consciousness
3%
Speech impairment (e.g., dysphasia or aphasia)
3%
Glomerular filtration rate
3%
SVT and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia (PAT)
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
734,024 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,317 Total Patients Enrolled
Sonali SmithPrincipal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
307 Total Patients Enrolled
~4 spots leftby Jun 2025
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