Trial Outcomes & Findings for R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma (NCT NCT00450801)
NCT ID: NCT00450801
Last Updated: 2015-11-10
Results Overview
Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2015-11-10
Participant Flow
Participant milestones
| Measure |
R-MACLO-IVAM-T
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
R-MACLO-IVAM-T
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
R-MACLO-IVAM-T
n=22 Participants
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
|---|---|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
|
Age, Customized
< 50 years
|
6 participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
8 participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
5 participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPercentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.
Outcome measures
| Measure |
R-MACLO-IVAM-T
n=21 Participants
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
R-IVAM Cycles
Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
Number of patients experiencing adverse events during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Progression-free Survival Rate
1 year progression-free survival
|
91 percentage of participants
Interval 68.0 to 98.0
|
—
|
—
|
|
Progression-free Survival Rate
3 year progression-free survival
|
78 percentage of participants
Interval 51.0 to 91.0
|
—
|
—
|
|
Progression-free Survival Rate
5-year progression-free survival
|
69 percentage of participants
Interval 40.0 to 86.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPercentage of participants who are alive up to five years after receipt of protocol therapy.
Outcome measures
| Measure |
R-MACLO-IVAM-T
n=21 Participants
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
R-IVAM Cycles
Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
Number of patients experiencing adverse events during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Overall Survival Rate
2-year overall survival Rate
|
96 percentage of participants
Interval 72.0 to 99.0
|
—
|
—
|
|
Overall Survival Rate
3-year overall survival rate
|
96 percentage of participants
Interval 72.0 to 99.0
|
—
|
—
|
|
Overall Survival Rate
4-year overall survival rate
|
87 percentage of participants
Interval 54.0 to 96.0
|
—
|
—
|
|
Overall Survival Rate
5-year overall survival rate
|
87 percentage of participants
Interval 54.0 to 96.0
|
—
|
—
|
|
Overall Survival Rate
1-year rate overall survival Rate
|
96 percentage of participants
Interval 72.0 to 99.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants who completed at least two cycles of therapy.
Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.
Outcome measures
| Measure |
R-MACLO-IVAM-T
n=21 Participants
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
R-IVAM Cycles
Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
Number of patients experiencing adverse events during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Response Rate
|
100 percentage of participants
Interval 83.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of patients experiencing adverse events during the course of protocol therapy.
Outcome measures
| Measure |
R-MACLO-IVAM-T
n=22 Participants
Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
|
R-IVAM Cycles
n=22 Participants
Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
n=20 Participants
Number of patients experiencing adverse events during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Number of Patients Experiencing Adverse Events.
|
22 participants
|
22 participants
|
19 participants
|
Adverse Events
R-MACLO Cycles
Serious events: 21 serious events
Other events: 22 other events
Deaths: 0 deaths
R-IVAM Cycles
Serious events: 21 serious events
Other events: 22 other events
Deaths: 0 deaths
Thalidomide Therapy
Serious events: 19 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-MACLO Cycles
n=22 participants at risk
Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
|
R-IVAM Cycles
n=22 participants at risk
Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
n=20 participants at risk
Adverse Events occurring during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Infections and infestations
Neutropenia (Grade 3-4)
|
54.5%
12/22 • Number of events 14
|
59.1%
13/22 • Number of events 20
|
35.0%
7/20 • Number of events 7
|
|
Metabolism and nutrition disorders
Anemia (Grade 3-4)
|
31.8%
7/22 • Number of events 7
|
86.4%
19/22 • Number of events 27
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Thrombocytopenia (Grade 3-4)
|
36.4%
8/22 • Number of events 8
|
95.5%
21/22 • Number of events 35
|
0.00%
0/20
|
|
Infections and infestations
Febrile neutropenia (Grade 3-4)
|
40.9%
9/22 • Number of events 9
|
90.9%
20/22 • Number of events 20
|
0.00%
0/20
|
|
Infections and infestations
Infection (Grade 3-4)
|
22.7%
5/22 • Number of events 5
|
50.0%
11/22 • Number of events 14
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Bacteremia (Grade 3-4)
|
9.1%
2/22 • Number of events 2
|
54.5%
12/22 • Number of events 12
|
0.00%
0/20
|
|
Infections and infestations
Mucositis (Grade 3-4)
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhea (Grade 3-4)
|
9.1%
2/22 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Grade 3-4)
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (Grade 3-4)
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Dizziness (Grade 3-4)
|
0.00%
0/22
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy (Grade 3-4)
|
0.00%
0/22
|
0.00%
0/22
|
40.0%
8/20 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Erectile Dysfunction (Grade 3-4)
|
0.00%
0/22
|
0.00%
0/22
|
10.0%
2/20 • Number of events 2
|
Other adverse events
| Measure |
R-MACLO Cycles
n=22 participants at risk
Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
|
R-IVAM Cycles
n=22 participants at risk
Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
|
Thalidomide Therapy
n=20 participants at risk
Adverse Events occurring during Thalidomide maintenance therapy.
|
|---|---|---|---|
|
Infections and infestations
Neutropenia (Grade 1-2)
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Anemia (Grade 1-2)
|
45.5%
10/22 • Number of events 11
|
18.2%
4/22 • Number of events 5
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Thrombocytopenia (Grade 1-2)
|
31.8%
7/22 • Number of events 7
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
Febrile Neutropenia (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
Infection (Grade 1-2)
|
4.5%
1/22 • Number of events 1
|
22.7%
5/22 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Bacteremia (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hyperglycemia (Grade 1-2)
|
45.5%
10/22 • Number of events 11
|
40.9%
9/22 • Number of events 10
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hypokalemia (Grade 1-2)
|
36.4%
8/22 • Number of events 9
|
50.0%
11/22 • Number of events 14
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Elevated creatinine (Grade 1-2)
|
27.3%
6/22 • Number of events 6
|
18.2%
4/22 • Number of events 4
|
0.00%
0/20
|
|
General disorders
Nausea (Grade 1-2)
|
40.9%
9/22 • Number of events 11
|
68.2%
15/22 • Number of events 18
|
0.00%
0/20
|
|
General disorders
Vomiting (Grade 1-2)
|
18.2%
4/22 • Number of events 4
|
45.5%
10/22 • Number of events 10
|
0.00%
0/20
|
|
Infections and infestations
Mucositis (Grade 1-2)
|
50.0%
11/22 • Number of events 13
|
36.4%
8/22 • Number of events 9
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhea (Grade 1-2)
|
22.7%
5/22 • Number of events 5
|
27.3%
6/22 • Number of events 6
|
0.00%
0/20
|
|
Gastrointestinal disorders
Constipation (Grade 1-2)
|
27.3%
6/22 • Number of events 6
|
22.7%
5/22 • Number of events 7
|
35.0%
7/20 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Grade 1-2)
|
22.7%
5/22 • Number of events 5
|
22.7%
5/22 • Number of events 5
|
0.00%
0/20
|
|
General disorders
Edema (Grade 1-2)
|
27.3%
6/22 • Number of events 6
|
13.6%
3/22 • Number of events 3
|
20.0%
4/20 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion (Grade 1-2)
|
13.6%
3/22 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Headache (Grade 1-2)
|
40.9%
9/22 • Number of events 10
|
18.2%
4/22 • Number of events 6
|
0.00%
0/20
|
|
General disorders
Dizziness (Grade 1-2)
|
9.1%
2/22 • Number of events 3
|
18.2%
4/22 • Number of events 5
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Rash (Grade 1-2)
|
22.7%
5/22 • Number of events 5
|
36.4%
8/22 • Number of events 9
|
0.00%
0/20
|
|
General disorders
Somnolence (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
15.0%
3/20 • Number of events 3
|
|
Nervous system disorders
Peripheral Neuropathy (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
10.0%
2/20 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile Dysfunction (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Bradycardia (Grade 1-2)
|
0.00%
0/22
|
0.00%
0/22
|
10.0%
2/20 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place