Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Follicular Lymphoma (FL) Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. |
Drug: Vorinostat
Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
Other Names:
|
Experimental: Indolent non-FL B-NHL or MCL Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. |
Drug: Vorinostat
Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
Other Names:
|
Experimental: Other Disease Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Drug: Vorinostat
Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [Up to 650 days]
ORR was defined as the percentage of participants who had a Complete Response (CR: Normal liver/spleen physical exam, all lymph nodes and nodal masses are normal, and there is no bone marrow involvement), a Complete Response/unconfirmed (CRu: Normal liver/spleen physical exam, plus at least a 75% decrease in the sum of the products of the greatest diameters of nodal masses if any are greater than 1.5 cm in their greatest diameter, normal or indeterminate bone marrow involvement), or a Partial Response (PR: Either normal physical exam, lymph nodes, and lymph node masses plus positive bone marrow involvement; OR normal physical exam or decrease in liver/spleen size plus at least a 50% decrease in the diameters of lymph nodes and nodal masses) as assessed using the international working group Non-Hodgkin's lymphoma standardized response criteria described by Cheson, BD in 1999. The percentage of participants who experienced a CR, CRu, or PR is presented.
- Number of Participants Who Experienced an Adverse Event (AE) [Up to approximately 29 months]
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was presented.
- Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) [Up to 536 days]
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued from study drug due to an adverse event was reported.
Secondary Outcome Measures
- Time to Treatment Failure for Relapsed/Refractory FL [Up to 650 days]
Time to Treatment Failure is defined as the time from allocation until the date of any treatment failure, including documented disease progression, or discontinuation of the study medication for any reason. Data was censored on the efficacy data cutoff date of 25 February, 2011.
- Time to Response for Relapsed/Refractory FL [Up to 650 days]
Time to Response is defined as the time from allocation until the time of an initial response. Data was censored on the efficacy data cutoff date of 25 February, 2011.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has an histopathologically confirmed follicular lymphoma (FL), or other indolent B-cell non-Hodgkin's lymphoma (B-NHL) or mantle cell lymphoma (MCL)
-
Only relapsed/refractory FL can be included outside Japan
-
Participant has at least one measurable lesion by computerized tomography (CT) scan which is defined by Cheson's 1999 criteria
-
Participant has received at least 1 but up to 4 prior chemotherapeutic regimens, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response
-
Life expectancy of >4 months
-
Participant must have adequate organ and marrow function
-
Women of child bearing potential must be negative for pregnancy and agree to use effective contraceptive measures until 30 days after the last dose of MK-0683.
-
Men must agree to use effective contraceptive measures until 6 months after the last dose of MK-0683
Exclusion Criteria:
-
Participant has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months
-
Participant with other active malignancies or central neurological infiltration with lymphoma
-
Participant with severe hepatic insufficiency
-
Participant with history of allergic reactions attributed to any component of MK-0683
-
Participant is known to be human immunodeficiency virus (HIV) antibody-, hepatitis B virus antigen- or hepatitis C virus antibody-positive
-
Participant has undergone prior/concomitant treatment with MK-0683 or other histone deacetylase (HDAC) inhibitors
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0683-103
- 2009_570
- 132248
- MK-0683-103
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Period Title: Overall Study | |||
STARTED | 39 | 11 | 6 |
COMPLETED | 16 | 2 | 0 |
NOT COMPLETED | 23 | 9 | 6 |
Baseline Characteristics
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease | Total |
---|---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. | Total of all reporting groups |
Overall Participants | 39 | 11 | 6 | 56 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
57.4
(10.4)
|
62.9
(9.7)
|
56.3
(10.5)
|
58.4
(10.4)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
24
61.5%
|
4
36.4%
|
2
33.3%
|
30
53.6%
|
Male |
15
38.5%
|
7
63.6%
|
4
66.7%
|
26
46.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
39
100%
|
11
100%
|
6
100%
|
56
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
39
100%
|
11
100%
|
6
100%
|
56
100%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Objective Response Rate (ORR) |
---|---|
Description | ORR was defined as the percentage of participants who had a Complete Response (CR: Normal liver/spleen physical exam, all lymph nodes and nodal masses are normal, and there is no bone marrow involvement), a Complete Response/unconfirmed (CRu: Normal liver/spleen physical exam, plus at least a 75% decrease in the sum of the products of the greatest diameters of nodal masses if any are greater than 1.5 cm in their greatest diameter, normal or indeterminate bone marrow involvement), or a Partial Response (PR: Either normal physical exam, lymph nodes, and lymph node masses plus positive bone marrow involvement; OR normal physical exam or decrease in liver/spleen size plus at least a 50% decrease in the diameters of lymph nodes and nodal masses) as assessed using the international working group Non-Hodgkin's lymphoma standardized response criteria described by Cheson, BD in 1999. The percentage of participants who experienced a CR, CRu, or PR is presented. |
Time Frame | Up to 650 days |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population included all allocated participants with follicular lymphoma (FL), non-FL B cell non-Hodgkin's lymphoma (B-NHL), or mantle cell lymphoma (MCL) who received at least one dose of study drug, and had some post-allocation endpoint data. |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Measure Participants | 39 | 11 | 0 |
Number (95% Confidence Interval) [Percentage of participants] |
48.7
124.9%
|
27.3
248.2%
|
Title | Number of Participants Who Experienced an Adverse Event (AE) |
---|---|
Description | An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was presented. |
Time Frame | Up to approximately 29 months |
Outcome Measure Data
Analysis Population Description |
---|
All allocated participants who received a dose of study drug were included in this analysis. |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Measure Participants | 39 | 11 | 6 |
Count of Participants [Participants] |
39
100%
|
11
100%
|
6
100%
|
Title | Time to Treatment Failure for Relapsed/Refractory FL |
---|---|
Description | Time to Treatment Failure is defined as the time from allocation until the date of any treatment failure, including documented disease progression, or discontinuation of the study medication for any reason. Data was censored on the efficacy data cutoff date of 25 February, 2011. |
Time Frame | Up to 650 days |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data. |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Measure Participants | 39 | 0 | 0 |
Median (Full Range) [Days] |
323
|
Title | Time to Response for Relapsed/Refractory FL |
---|---|
Description | Time to Response is defined as the time from allocation until the time of an initial response. Data was censored on the efficacy data cutoff date of 25 February, 2011. |
Time Frame | Up to 650 days |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data. |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Measure Participants | 39 | 0 | 0 |
Median (Full Range) [Days] |
NA
|
Title | Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) |
---|---|
Description | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued from study drug due to an adverse event was reported. |
Time Frame | Up to 536 days |
Outcome Measure Data
Analysis Population Description |
---|
All allocated participants who received a dose of study drug were included in this analysis. |
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease |
---|---|---|---|
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. |
Measure Participants | 39 | 11 | 6 |
Count of Participants [Participants] |
6
15.4%
|
1
9.1%
|
2
33.3%
|
Adverse Events
Time Frame | Up to approximately 29 months | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants. | |||||
Arm/Group Title | Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease | |||
Arm/Group Description | Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. | Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol. | |||
All Cause Mortality |
||||||
Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/39 (10.3%) | 3/11 (27.3%) | 2/6 (33.3%) | |||
Serious Adverse Events |
||||||
Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 9/39 (23.1%) | 3/11 (27.3%) | 2/6 (33.3%) | |||
Blood and lymphatic system disorders | ||||||
Neutropenia | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Thrombocytopenia | 2/39 (5.1%) | 2 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Gastrointestinal disorders | ||||||
Abdominal pain | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
General disorders | ||||||
Asthenia | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Infections and infestations | ||||||
H1N1 influenza | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Meningitis aseptic | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Pneumonia | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Muscle injury | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Metabolism and nutrition disorders | ||||||
Decreased appetite | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Breast cancer | 0/39 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Nervous system disorders | ||||||
Dizziness | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
VIth nerve paralysis | 0/39 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||
Pleural effusion | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Pleural haemorrhage | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Vascular disorders | ||||||
Deep vein thrombosis | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Embolism venous | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Follicular Lymphoma (FL) | Indolent Non-FL B-NHL or MCL | Other Disease | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 39/39 (100%) | 11/11 (100%) | 6/6 (100%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 13/39 (33.3%) | 24 | 5/11 (45.5%) | 11 | 1/6 (16.7%) | 1 |
Erythropenia | 0/39 (0%) | 0 | 1/11 (9.1%) | 3 | 0/6 (0%) | 0 |
Leukopenia | 20/39 (51.3%) | 93 | 8/11 (72.7%) | 42 | 3/6 (50%) | 11 |
Lymphadenitis | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Lymphopenia | 13/39 (33.3%) | 36 | 6/11 (54.5%) | 17 | 0/6 (0%) | 0 |
Neutropenia | 28/39 (71.8%) | 138 | 7/11 (63.6%) | 61 | 2/6 (33.3%) | 7 |
Thrombocytopenia | 37/39 (94.9%) | 171 | 10/11 (90.9%) | 56 | 5/6 (83.3%) | 15 |
Cardiac disorders | ||||||
Palpitations | 4/39 (10.3%) | 5 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Supraventricular extrasystoles | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Ear and labyrinth disorders | ||||||
Tinnitus | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Eye disorders | ||||||
Conjunctivitis | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Gastrointestinal disorders | ||||||
Abdominal discomfort | 3/39 (7.7%) | 8 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Abdominal distension | 3/39 (7.7%) | 8 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Abdominal pain | 6/39 (15.4%) | 7 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Abdominal pain upper | 5/39 (12.8%) | 7 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Cheilitis | 3/39 (7.7%) | 7 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
Constipation | 15/39 (38.5%) | 30 | 3/11 (27.3%) | 7 | 1/6 (16.7%) | 1 |
Dental caries | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Diarrhoea | 28/39 (71.8%) | 247 | 9/11 (81.8%) | 89 | 5/6 (83.3%) | 15 |
Dry mouth | 4/39 (10.3%) | 10 | 1/11 (9.1%) | 3 | 0/6 (0%) | 0 |
Dyspepsia | 3/39 (7.7%) | 5 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
Enterocolitis | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Flatulence | 2/39 (5.1%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Gastritis | 4/39 (10.3%) | 4 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Glossodynia | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Haemorrhoids | 1/39 (2.6%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Nausea | 24/39 (61.5%) | 89 | 7/11 (63.6%) | 12 | 3/6 (50%) | 4 |
Stomatitis | 9/39 (23.1%) | 24 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Vomiting | 13/39 (33.3%) | 47 | 1/11 (9.1%) | 1 | 2/6 (33.3%) | 4 |
General disorders | ||||||
Asthenia | 6/39 (15.4%) | 18 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Chest discomfort | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Chest pain | 4/39 (10.3%) | 4 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Chills | 2/39 (5.1%) | 4 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Face oedema | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Facial pain | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Fatigue | 22/39 (56.4%) | 90 | 5/11 (45.5%) | 14 | 2/6 (33.3%) | 4 |
Influenza like illness | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Mucosal inflammation | 3/39 (7.7%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Oedema | 1/39 (2.6%) | 1 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
Oedema peripheral | 3/39 (7.7%) | 3 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Puncture site pain | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Pyrexia | 4/39 (10.3%) | 4 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hepatobiliary disorders | ||||||
Hyperbilirubinaemia | 10/39 (25.6%) | 34 | 3/11 (27.3%) | 10 | 1/6 (16.7%) | 1 |
Immune system disorders | ||||||
Hypersensitivity | 0/39 (0%) | 0 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Infections and infestations | ||||||
Influenza | 3/39 (7.7%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Nasopharyngitis | 17/39 (43.6%) | 37 | 4/11 (36.4%) | 9 | 1/6 (16.7%) | 1 |
Oral herpes | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Pharyngitis | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Upper aerodigestive tract infection | 0/39 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Upper respiratory tract infection | 6/39 (15.4%) | 11 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Accidental overdose | 9/39 (23.1%) | 9 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Animal bite | 4/39 (10.3%) | 4 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Investigations | ||||||
Alanine aminotransferase increased | 9/39 (23.1%) | 20 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 2 |
Aspartate aminotransferase increased | 10/39 (25.6%) | 21 | 4/11 (36.4%) | 7 | 1/6 (16.7%) | 2 |
Blood bilirubin increased | 3/39 (7.7%) | 6 | 1/11 (9.1%) | 3 | 0/6 (0%) | 0 |
Blood creatine phosphokinase increased | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Blood creatinine increased | 9/39 (23.1%) | 39 | 2/11 (18.2%) | 7 | 2/6 (33.3%) | 7 |
Blood lactate dehydrogenase increased | 5/39 (12.8%) | 9 | 2/11 (18.2%) | 13 | 2/6 (33.3%) | 7 |
Blood phosphorus decreased | 0/39 (0%) | 0 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Blood urea increased | 4/39 (10.3%) | 9 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Weight decreased | 11/39 (28.2%) | 11 | 3/11 (27.3%) | 3 | 1/6 (16.7%) | 1 |
Metabolism and nutrition disorders | ||||||
Decreased appetite | 26/39 (66.7%) | 120 | 6/11 (54.5%) | 15 | 3/6 (50%) | 3 |
Dehydration | 3/39 (7.7%) | 15 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hypercreatininaemia | 7/39 (17.9%) | 22 | 2/11 (18.2%) | 8 | 1/6 (16.7%) | 2 |
Hyperglycaemia | 9/39 (23.1%) | 20 | 4/11 (36.4%) | 7 | 0/6 (0%) | 0 |
Hyperkalaemia | 3/39 (7.7%) | 13 | 3/11 (27.3%) | 12 | 0/6 (0%) | 0 |
Hypermagnesaemia | 5/39 (12.8%) | 22 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hyperphosphataemia | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
Hyperphosphatasaemia | 2/39 (5.1%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hypoalbuminaemia | 4/39 (10.3%) | 24 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Hypocalcaemia | 4/39 (10.3%) | 14 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hypokalaemia | 3/39 (7.7%) | 11 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hyponatraemia | 3/39 (7.7%) | 6 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Hypophosphataemia | 10/39 (25.6%) | 32 | 1/11 (9.1%) | 10 | 1/6 (16.7%) | 1 |
Hypoproteinaemia | 2/39 (5.1%) | 7 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Back pain | 3/39 (7.7%) | 3 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Muscle spasms | 3/39 (7.7%) | 5 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Myositis | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Pain in extremity | 3/39 (7.7%) | 5 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Nervous system disorders | ||||||
Dizziness | 3/39 (7.7%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Dysgeusia | 14/39 (35.9%) | 66 | 3/11 (27.3%) | 5 | 3/6 (50%) | 3 |
Headache | 7/39 (17.9%) | 12 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Hyperaesthesia | 1/39 (2.6%) | 2 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Hypoaesthesia | 3/39 (7.7%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Neuropathy peripheral | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Peripheral sensory neuropathy | 3/39 (7.7%) | 5 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Somnolence | 2/39 (5.1%) | 4 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Psychiatric disorders | ||||||
Anxiety | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Depression | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Insomnia | 2/39 (5.1%) | 3 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
Renal and urinary disorders | ||||||
Haematuria | 1/39 (2.6%) | 1 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 2 |
Proteinuria | 6/39 (15.4%) | 13 | 2/11 (18.2%) | 4 | 1/6 (16.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 5/39 (12.8%) | 8 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Dysphonia | 1/39 (2.6%) | 1 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Dyspnoea | 2/39 (5.1%) | 2 | 1/11 (9.1%) | 2 | 0/6 (0%) | 0 |
Oropharyngeal pain | 5/39 (12.8%) | 7 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
Productive cough | 1/39 (2.6%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Rhinorrhoea | 4/39 (10.3%) | 10 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Upper respiratory tract inflammation | 6/39 (15.4%) | 13 | 1/11 (9.1%) | 4 | 1/6 (16.7%) | 1 |
Skin and subcutaneous tissue disorders | ||||||
Alopecia | 20/39 (51.3%) | 20 | 4/11 (36.4%) | 4 | 2/6 (33.3%) | 2 |
Asteatosis | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Dermatitis acneiform | 0/39 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Erythema nodosum | 0/39 (0%) | 0 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Haemorrhage subcutaneous | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Nail disorder | 8/39 (20.5%) | 8 | 1/11 (9.1%) | 1 | 1/6 (16.7%) | 1 |
Night sweats | 3/39 (7.7%) | 3 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Photosensitivity reaction | 0/39 (0%) | 0 | 0/11 (0%) | 0 | 1/6 (16.7%) | 1 |
Pruritus | 1/39 (2.6%) | 3 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Rash | 8/39 (20.5%) | 11 | 2/11 (18.2%) | 2 | 0/6 (0%) | 0 |
Skin exfoliation | 1/39 (2.6%) | 1 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Vascular disorders | ||||||
Hot flush | 2/39 (5.1%) | 2 | 0/11 (0%) | 0 | 0/6 (0%) | 0 |
Hypertension | 2/39 (5.1%) | 2 | 1/11 (9.1%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- 0683-103
- 2009_570
- 132248
- MK-0683-103