Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02636322

Recruitment Status : Completed

First Posted : December 21, 2015

Results First Posted : March 13, 2024

Last Update Posted : March 13, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Diffuse Large B-Cell Lymphoma Unclassifiable
Interventions	Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Etoposide Drug: Ibrutinib Drug: Lenalidomide Drug: Prednisone Biological: Rituximab Drug: Vincristine Sulfate
Enrollment	60

Participant Flow

Recruitment Details	for testing in up to 60 patients with newly diagnosed ABC DLBCL. Patients will start with RLI alone prior to the use of chemotherapy ("Smart Start") for ≤2 cycles, followed by 6 cycles of RLI with dose adjusted (DA) EPOCH.
Pre-assignment Details


Arm/Group Title	RLI WITH EPOCH/RCHOP
Arm/Group Description	SMART START: Patients receive ritux...
Arm/Group Description	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started	58
Complete Response	21
Partial Response	29
Non Responsive	8
Completed	58
Not Completed	0

Baseline Characteristics

Arm/Group Title		RLI WITH EPOCH/R-CHOP
Arm/Group Description		SMART START: Patients receive ritux...
Arm/Group Description		SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants		60
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	32 53.3%
	>=65 years	28 46.7%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	60 participants
		63.5 (29 to 83)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants
	Female	28 46.7%
	Male	32 53.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants
	Hispanic or Latino	7 11.7%
	Not Hispanic or Latino	53 88.3%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	60 participants
	American Indian or Alaska Native	0 0.0%
	Asian	3 5.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 5.0%
	White	47 78.3%
	More than one race	7 11.7%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	60 participants
United States		60

Outcome Measures

1.Primary Outcome


Title	Overall Response Rate
Description	After two cycles of RLI
Description	After two cycles of RLI
Time Frame	Up to 42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RLI With EPOCH/CHOP
Arm/Group Description:	SMART START: Patients receive ritux...
Arm/Group Description:	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	58
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	86.2 (74.6 to 93.9)

2.Primary Outcome


Title	Overall Response Rate
Description	After two cycles of RLI plus two cycles of RLI-chemotherapy
Description	After two cycles of RLI plus two cycles of RLI-chemotherapy
Time Frame	up to 84 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RLI With EPOCH/CHOP
Arm/Group Description:	SMART START: Patients receive ritux...
Arm/Group Description:	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	58
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	100 (93.6 to 100)

3.Secondary Outcome


Title	Progression Free Survival at 2 Years
Description	[Not Specified]
Description	[Not Specified]
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RLI With EPOCH/CHOP
Arm/Group Description:	SMART START: Patients receive ritux...
Arm/Group Description:	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	58
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	91.3 (84.3 to 98.9)

4.Secondary Outcome


Title	Overall Survival for 2 Years
Description	[Not Specified]
Description	[Not Specified]
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RLI WITH EPOCH/RCHOP
Arm/Group Description:	SMART START: Patients receive ritux...
Arm/Group Description:	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	58
Measure Type: Count of Participants Unit of Measure: Participants
	58 100.0%

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	RLI WITH EPOCH/R-CHOP
Arm/Group Description	SMART START: Patients receive ritux...
Arm/Group Description	SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
	RLI WITH EPOCH/R-CHOP
	Affected / at Risk (%)
Total	2/60 (3.33%)
Serious Adverse Events Serious Adverse Events
	RLI WITH EPOCH/R-CHOP
	Affected / at Risk (%)	# Events
Total	24/60 (40.00%)
Blood and lymphatic system disorders
Anemia ^† 1	1/60 (1.67%)	1
Blood and Lymphatic other lymphoma tumor abscess, axilla ^† 1	1/60 (1.67%)	1
Febrile Neutropenia ^† 1	24/60 (40.00%)	31
Cardiac disorders
Atrial fibrilation ^† 1	2/60 (3.33%)	2
Atrial flutter ^† 1	1/60 (1.67%)	1
Chest pain ^† 1	1/60 (1.67%)	1
Myocardial infarction ^† 1	1/60 (1.67%)	1
Sinus tachycardia ^† 1	1/60 (1.67%)	1
Gastrointestinal disorders
Abdominal Pain ^† 1	2/60 (3.33%)	2
Diarrhea ^† 1	5/60 (8.33%)	5
Mucositis oral ^† 1	3/60 (5.00%)	3
Nausea ^† 1	1/60 (1.67%)	2
Rectal pain ^† 1	2/60 (3.33%)	2
Vomiting ^† 1	1/60 (1.67%)	2
General disorders
Fatigue ^† 1	2/60 (3.33%)	2
Fever ^† 1	7/60 (11.67%)	8
Multi-organ failure ^† 1	1/60 (1.67%)	1
Non-cardiac chest pain ^† 1	1/60 (1.67%)	1
Infections and infestations
Encephalitis infection ^† 1	1/60 (1.67%)	1
Enterocolitis infectious ^† 1	2/60 (3.33%)	2
Infections and infestations - Other, Acute kidney infection ^† 1	1/60 (1.67%)	1
Infections and infestations - Other, Bacteremia ^† 1	1/60 (1.67%)	1
Lung infection ^† 1	1/60 (1.67%)	3
Urinary tract infection ^† 1	2/60 (3.33%)	2
Wound infection ^† 1	1/60 (1.67%)	1
Injury, poisoning and procedural complications
Fall ^† 1	2/60 (3.33%)	2
Investigations
Neutrophil count decreased ^† 1	4/60 (6.67%)	5
Platelet count decrease ^† 1	1/60 (1.67%)	1
White blood cell decrease ^† 1	1/60 (1.67%)	1
Metabolism and nutrition disorders
Dehydration ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	1/60 (1.67%)	1
Back pain ^† 1	2/60 (3.33%)	2
Neck pain ^† 1	1/60 (1.67%)	1
Nervous system disorders
Dizziness ^† 1	1/60 (1.67%)	1
Memory impairment ^† 1	1/60 (1.67%)	1
Syncope ^† 1	5/60 (8.33%)	5
Renal and urinary disorders
Acute Kidney injury ^† 1	2/60 (3.33%)	2
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	1/60 (1.67%)	1
Dyspnea ^† 1	1/60 (1.67%)	1
Upper respiratory infection ^† 1	2/60 (3.33%)	2
Skin and subcutaneous tissue disorders
Rash acneiform ^† 1	1/60 (1.67%)	1
Rash maculo-papular ^† 1	2/60 (3.33%)	2
Skin and subcutaneous Cellulitis right foot ^† 1	1/60 (1.67%)	1
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	RLI WITH EPOCH/R-CHOP
	Affected / at Risk (%)	# Events
Total	60/60 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	42/60 (70.00%)	141
Febrile Neutorpenia ^† 1	2/60 (3.33%)	2
Leukocytosis ^† 1	2/60 (3.33%)	5
Cardiac disorders
Artrial fibliration ^† 1	5/60 (8.33%)	6
Atrial Flutter ^† 1	1/60 (1.67%)	1
Cardiac disorders - Other, specify increase heart rate ^† 1	1/60 (1.67%)	1
Palpatations ^† 1	3/60 (5.00%)	4
Sinus tachycardia ^† 1	2/60 (3.33%)	2
Superior vena cava syndrome ^† 1	1/60 (1.67%)	1
Ear and labyrinth disorders
"Ear and labyrinth disorders - Other Ear discharge bilateral" ^† 1	1/60 (1.67%)	1
Tinnitus ^† 1	5/60 (8.33%)	5
Endocrine disorders
Endocrine disorder Polydipsia ^† 1	1/60 (1.67%)	1
Endocrine disorder Polyuria ^† 1	1/60 (1.67%)	1
Eye disorders
Blurred vision ^† 1	21/60 (35.00%)	23
Conjunctivitis ^† 1	1/60 (1.67%)	1
Dry Eye ^† 1	17/60 (28.33%)	18
Eye disorder Blepharitis of right eye ^† 1	1/60 (1.67%)	1
Eye disorder light sensitivity ^† 1	1/60 (1.67%)	1
Eye infection ^† 1	1/60 (1.67%)	1
Watering eyes ^† 1	14/60 (23.33%)	14
Gastrointestinal disorders
Abdominal pain ^† 1	8/60 (13.33%)	8
Colitis ^† 1	1/60 (1.67%)	1
Constipation ^† 1	42/60 (70.00%)	54
Diarrhea ^† 1	47/60 (78.33%)	81
Dyspepsia ^† 1	1/60 (1.67%)	1
Dysphagia ^† 1	1/60 (1.67%)	1
Enterocolitis ^† 1	2/60 (3.33%)	2
Gastroesophageal reflux disease ^† 1	4/60 (6.67%)	4
Gastrointestinal disorders - Other, Ulcer on left oral cavity ^† 1	1/60 (1.67%)	1
Gastrointestinal disorders - Other, bloody stool ^† 1	1/60 (1.67%)	1
Gastrointestinal disorders - Other, indigestion ^† 1	1/60 (1.67%)	1
Hemorrhoids ^† 1	1/60 (1.67%)	1
Mucositis oral ^† 1	45/60 (75.00%)	61
Nausea ^† 1	51/60 (85.00%)	72
Oral dysesthesia ^† 1	1/60 (1.67%)	1
Pharyngitis ^† 1	1/60 (1.67%)	1
Rectal hemorrhage ^† 1	1/60 (1.67%)	1
Rectal Pain ^† 1	1/60 (1.67%)	1
Sore throat ^† 1	3/60 (5.00%)	3
Vomiting ^† 1	21/60 (35.00%)	24
General disorders
Chills ^† 1	1/60 (1.67%)	1
Edema face ^† 1	2/60 (3.33%)	2
Edema Limbs ^† 1	30/60 (50.00%)	38
Edema trunk ^† 1	1/60 (1.67%)	2
Facila pain ^† 1	1/60 (1.67%)	1
Fatigue ^† 1	58/60 (96.67%)	80
Fever ^† 1	20/60 (33.33%)	23
Flu like symptoms ^† 1	1/60 (1.67%)	1
Gait disturbance ^† 1	2/60 (3.33%)	2
Generalized edema ^† 1	1/60 (1.67%)	1
Localized edema ^† 1	1/60 (1.67%)	1
Non-cardiac chest pain ^† 1	2/60 (3.33%)	2
Pain ^† 1	3/60 (5.00%)	3
Immune system disorders
Allergic reaction ^† 1	1/60 (1.67%)	1
Infections and infestations
Bacteremia ^† 1	1/60 (1.67%)	1
Infections and infestations others right great toe ^† 1	2/60 (3.33%)	2
Infections and infestations others ^† 1	1/60 (1.67%)	1
Infections other Clostridium Difficile infection ^† 1	1/60 (1.67%)	1
Infections and infestations others vaginal yeast ^† 1	1/60 (1.67%)	1
Infections and infestations others Coronavirus ^† 1	1/60 (1.67%)	1
Infections and infestations others Oral Candidiasis ^† 1	1/60 (1.67%)	1
Infections and infestations others left great toe ^† 1	1/60 (1.67%)	1
Paronychia ^† 1	1/60 (1.67%)	1
Sepsis ^† 1	1/60 (1.67%)	1
upper respiratory infection ^† 1	2/60 (3.33%)	2
Injury, poisoning and procedural complications
Bruising ^† 1	1/60 (1.67%)	1
Investigations
Alanine aminotransferase increased ^† 1	8/60 (13.33%)	15
Aspartate aminotransferase increased ^† 1	8/60 (13.33%)	8
Blood bilirubin increase ^† 1	4/60 (6.67%)	5
Creatinine increase ^† 1	6/60 (10.00%)	7
Hypercalcemia ^† 1	2/60 (3.33%)	2
Hyperglycemia ^† 1	1/60 (1.67%)	4
Hyperuricemia ^† 1	1/60 (1.67%)	1
Hypoalbuminemia ^† 1	2/60 (3.33%)	2
Hypocalcemia ^† 1	2/60 (3.33%)	5
Hypokalemia ^† 1	13/60 (21.67%)	31
Hypomagnesemia ^† 1	7/60 (11.67%)	8
Hyponatremia ^† 1	7/60 (11.67%)	10
Hypophosphatemia ^† 1	6/60 (10.00%)	12
Neutrophil count decrease ^† 1	36/60 (60.00%)	95
Platelet count decrease ^† 1	40/60 (66.67%)	146
Weight loss ^† 1	4/60 (6.67%)	5
Metabolism and nutrition disorders
Anorexia ^† 1	2/60 (3.33%)	2
Dehydration ^† 1	3/60 (5.00%)	3
Metabolism and nutrition disorders other diaphoresis ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	5/60 (8.33%)	5
Back Pain ^† 1	6/60 (10.00%)	8
Bone pain ^† 1	1/60 (1.67%)	2
Chest wall pain ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorder - Other, Restless leg syndrome ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorder - Other, Arthralgia ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorder - Other,Leg Cramps ^† 1	1/60 (1.67%)	1
Musculoskeletal and connective tissue disorder - Other, Hand cramp ^† 1	1/60 (1.67%)	1
Myalgia ^† 1	35/60 (58.33%)	45
Neck pain ^† 1	1/60 (1.67%)	1
Pain extremity ^† 1	3/60 (5.00%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) Left thigh nodule ^† 1	1/60 (1.67%)	1
Nervous system disorders
Amnesia ^† 1	1/60 (1.67%)	1
Dizziness ^† 1	32/60 (53.33%)	38
Headache ^† 1	13/60 (21.67%)	17
Nervous system disorders - Other, neck stiffness ^† 1	1/60 (1.67%)	1
Paresthesia ^† 1	4/60 (6.67%)	4
Peripheral motor neuropathy ^† 1	1/60 (1.67%)	1
Peripheral sensory neuropathy ^† 1	49/60 (81.67%)	78
presyncope ^† 1	1/60 (1.67%)	1
Syncope ^† 1	2/60 (3.33%)	2
Psychiatric disorders
Anxiety ^† 1	4/60 (6.67%)	4
Confusion ^† 1	1/60 (1.67%)	1
Depression ^† 1	1/60 (1.67%)	1
insomnia ^† 1	9/60 (15.00%)	9
memory impairment ^† 1	23/60 (38.33%)	23
Renal and urinary disorders
Acute Kidney injury ^† 1	1/60 (1.67%)	1
Bladder infection ^† 1	1/60 (1.67%)	2
Dysuria ^† 1	1/60 (1.67%)	1
Hematuria ^† 1	1/60 (1.67%)	2
Urinary tract infection ^† 1	8/60 (13.33%)	11
Reproductive system and breast disorders
Hoarseness ^† 1	1/60 (1.67%)	1
lung infection ^† 1	1/60 (1.67%)	1
Reproductive System and Breast Disorders vaginal bleeding ^† 1	2/60 (3.33%)	3
Vaginal infection ^† 1	1/60 (1.67%)	1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	5/60 (8.33%)	5
Cough ^† 1	11/60 (18.33%)	12
Dyspnea ^† 1	26/60 (43.33%)	32
Epistaxis ^† 1	3/60 (5.00%)	3
Nasal congestionres ^† 1	6/60 (10.00%)	6
Pleural effusion ^† 1	1/60 (1.67%)	1
postnasal drip ^† 1	5/60 (8.33%)	5
Productive cough ^† 1	3/60 (5.00%)	3
Respiratory failure ^† 1	1/60 (1.67%)	1
Respiratory, thoracicand mediastinal disorder thoat pain ^† 1	1/60 (1.67%)	1
Respiratory, thoracicand mediastinal disorder Bronchitis ^† 1	1/60 (1.67%)	1
Rhinitis infective ^† 1	1/60 (1.67%)	1
Rhinorrhea ^† 1	5/60 (8.33%)	5
Sinusitis ^† 1	3/60 (5.00%)	3
Skin and subcutaneous tissue disorders
Dry Skin ^† 1	1/60 (1.67%)	1
Hyperhidrosis ^† 1	1/60 (1.67%)	1
Hyperkalemia ^† 1	1/60 (1.67%)	1
Pruritis ^† 1	1/60 (1.67%)	1
Purpura ^† 1	1/60 (1.67%)	1
Rash acneiform ^† 1	11/60 (18.33%)	15
rash maculo-papular ^† 1	18/60 (30.00%)	26
Skin and subcutaneous tissue disorders Fungal rash on feet ^† 1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders left areola redness ^† 1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders blisters on hands and feet bilateral ^† 1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders itchy scalp ^† 1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders rash on torso and feet ^† 1	1/60 (1.67%)	1
Skin and subcutaneous tissue disorders Scalp tenderness ^† 1	1/60 (1.67%)	1
Vascular disorders
Hot flashes ^† 1	2/60 (3.33%)	2
Hypotension ^† 1	4/60 (6.67%)	4
Ileus ^† 1	1/60 (1.67%)	1
Vascular access complication ^† 1	1/60 (1.67%)	1
vascular other Thrombus non occlusive ^† 1	1/60 (1.67%)	1
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Jason Westin
Organization:	University of Texas M D Anderson Cancer Center
Phone:	(713) 792-3750
EMail:	jwestin@mdanderson.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Westin J, Davis RE, Feng L, Hagemeister F, Steiner R, Lee HJ, Fayad L, Nastoupil L, Ahmed S, Rodriguez A, Fanale M, Samaniego F, Iyer SP, Nair R, Oki Y, Fowler N, Wang M, Ma MCJ, Vega F, McDonnell T, Pinnix C, Griffith D, Lu Y, Tewari S, Sun R, Scott DW, Flowers CR, Neelapu S, Green MR. Smart Start: Rituximab, Lenalidomide, and Ibrutinib in Patients With Newly Diagnosed Large B-Cell Lymphoma. J Clin Oncol. 2023 Feb 1;41(4):745-755. doi: 10.1200/JCO.22.00597. Epub 2022 Aug 11.

Layout table for additonal information

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT02636322
Other Study ID Numbers:	2015-0147 NCI-2016-00017 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2015-0147 ( Other Identifier: M D Anderson Cancer Center )
First Submitted:	December 17, 2015
First Posted:	December 21, 2015
Results First Submitted:	September 28, 2023
Results First Posted:	March 13, 2024
Last Update Posted:	March 13, 2024

To Top