Trial Outcomes & Findings for Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma (NCT NCT02633137)
NCT ID: NCT02633137
Last Updated: 2024-08-30
Results Overview
acceptable 3-yr PFS as 75% or higher, and unacceptable rate as 60% or lower.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
3 years
Results posted on
2024-08-30
Participant Flow
Participant milestones
| Measure |
Chemotherapy
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Chemotherapy
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Chemotherapy
n=49 Participants
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsacceptable 3-yr PFS as 75% or higher, and unacceptable rate as 60% or lower.
Outcome measures
| Measure |
Chemotherapy
n=49 Participants
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
3-year Progression-free Survival (PFS)
|
63 % of pts progression-free survival
Interval 50.0 to 78.0
|
Adverse Events
Chemotherapy
Serious events: 27 serious events
Other events: 44 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Chemotherapy
n=49 participants at risk
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
3/49 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.2%
4/49 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
3/49 • 3 years
|
|
Cardiac disorders
Other cardiac disorder
|
2.0%
1/49 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • 3 years
|
|
Investigations
Creatinine increased
|
2.0%
1/49 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.1%
2/49 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.1%
2/49 • 3 years
|
|
General disorders
Edema limbs
|
2.0%
1/49 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
2.0%
1/49 • 3 years
|
|
General disorders
Fatigue
|
2.0%
1/49 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
46.9%
23/49 • 3 years
|
|
General disorders
Fever
|
6.1%
3/49 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/49 • 3 years
|
|
Infections and infestations
Other infections and infestations
|
2.0%
1/49 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.0%
1/49 • 3 years
|
|
Infections and infestations
Lung infection
|
10.2%
5/49 • 3 years
|
|
Investigations
Neutrophil count decreased
|
8.2%
4/49 • 3 years
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49 • 3 years
|
|
Investigations
Platelet count decreased
|
16.3%
8/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/49 • 3 years
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/49 • 3 years
|
|
Infections and infestations
Skin infection
|
2.0%
1/49 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/49 • 3 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.0%
1/49 • 3 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.0%
1/49 • 3 years
|
|
Investigations
White blood cell decreased
|
2.0%
1/49 • 3 years
|
Other adverse events
| Measure |
Chemotherapy
n=49 participants at risk
Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
89.8%
44/49 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
89.8%
44/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
81.6%
40/49 • 3 years
|
|
Investigations
Neutrophil count decreased
|
81.6%
40/49 • 3 years
|
|
Investigations
White blood cell decreased
|
81.6%
40/49 • 3 years
|
|
Investigations
Platelet count decreased
|
79.6%
39/49 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
77.6%
38/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.9%
21/49 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
40.8%
20/49 • 3 years
|
|
General disorders
Fatigue
|
34.7%
17/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
34.7%
17/49 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
32.7%
16/49 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
28.6%
14/49 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
26.5%
13/49 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.4%
11/49 • 3 years
|
|
Investigations
Blood bilirubin increased
|
20.4%
10/49 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
20.4%
10/49 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.4%
10/49 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
18.4%
9/49 • 3 years
|
|
Psychiatric disorders
Anxiety
|
14.3%
7/49 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
7/49 • 3 years
|
|
Investigations
Creatinine increased
|
14.3%
7/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
7/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
7/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
7/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
7/49 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
7/49 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
6/49 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.2%
5/49 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
5/49 • 3 years
|
|
General disorders
Edema limbs
|
10.2%
5/49 • 3 years
|
|
General disorders
Other general disorders and administration site conditions
|
10.2%
5/49 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.2%
5/49 • 3 years
|
|
Investigations
Weight loss
|
10.2%
5/49 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
8.2%
4/49 • 3 years
|
|
Psychiatric disorders
Depression
|
8.2%
4/49 • 3 years
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • 3 years
|
|
Vascular disorders
Hypertension
|
8.2%
4/49 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
8.2%
4/49 • 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.1%
3/49 • 3 years
|
|
Cardiac disorders
Chest pain-cardiac
|
6.1%
3/49 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
3/49 • 3 years
|
|
General disorders
Fever
|
6.1%
3/49 • 3 years
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • 3 years
|
|
Infections and infestations
Other infections and infestations
|
6.1%
3/49 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.1%
3/49 • 3 years
|
Additional Information
Dr. Anita Kumar, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3780
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place