← Back to Search

Alkylating Agent

lenalidomide for Diffuse Large B-Cell Lymphoma (ROBUST Trial)

Phase 3
Waitlist Available
Research Sponsored by Celgene
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 from randomization date up to the data cut off date of 15 march 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for r2-chop arm and 0.3 to 22.9 weeks for placebo-r-chop arm
Awards & highlights

ROBUST Trial Summary

This trial is testing a new chemotherapy regimen against the standard of care to see if it is more effective and has fewer side effects.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma

ROBUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization up to the data cut off date of 15 march 2019; median follow-up of 24.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization up to the data cut off date of 15 march 2019; median follow-up of 24.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kaplan-Meier Estimate of Progression Free Survival (PFS)
Secondary outcome measures
K-M Estimate of Duration of Complete Response
K-M Estimate of Overall Survival (OS)
Therapeutic procedure
+11 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%
Insomnia
20%
Dizziness
20%
Pain - Bone
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%
Taste alteration (dysgeusia)
13%
Pain - Head/headache
13%
Mucositis/stomatitis (clinical exam) - Oral cavity
13%
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
13%
Phosphate, serum-low (hypophosphatemia)
13%
Vision-blurred vision
13%
Muscle weakness, not d/t neuropathy - body/general
13%
Cough
10%
Neuropathy: motor
10%
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
10%
Bilirubin (hyperbilirubinemia)
10%
Rash: acne/acneiform
10%
Alkaline phosphatase
10%
Weight gain
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-Other (Specify)
8%
Inf w/normal absolute neutrophil count (ANC) or Gr 1-2 neutrophils - Bronchus
8%
Pain - Chest/thorax NOS
8%
Musculoskeletal/Soft Tissue-Other (Specify)
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%
Confusion
5%
Memory impairment
5%
Hot flashes/flushes
5%
Rigors/chills
5%
Infection with unknown ANC - Sinus
5%
Mood alteration - agitation
5%
Infection with unknown ANC - Skin (cellulitis)
5%
Pain - Neck
5%
Ocular/Visual-Other (Specify)
5%
Metabolic/Laboratory-Other (Specify)
5%
Tremor
5%
Osteonecrosis (avascular necrosis)
5%
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
5%
Dyspnea (shortness of breath)
5%
Sweating (diaphoresis)
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%
Colitis
3%
Syncope (fainting)
3%
Left ventricular diastolic dysfunction
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

ROBUST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: R2-CHOPExperimental Treatment6 Interventions
Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
Group II: R-CHOPActive Control6 Interventions
Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
vincristine
2005
Completed Phase 4
~3840
prednisone
1999
Completed Phase 3
~10920
lenalidomide
2012
Completed Phase 3
~3920
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
633 Previous Clinical Trials
127,472 Total Patients Enrolled
Stacey Kalambakas, M.DStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,501 Previous Clinical Trials
3,367,100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
2015. "Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02285062.
~56 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top