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Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT01812005
Recruitment Status : Terminated (Slow patient enrollment and study discontinued after 14 patients enrolled)
First Posted : March 15, 2013
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Interventions Drug: alisertib
Biological: rituximab
Other: laboratory biomarker analysis
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Period Title: Overall Study
Started 1 13
Completed 1 13
Not Completed 0 0
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab) Total
Hide Arm/Group Description

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Total of all reporting groups
Overall Number of Baseline Participants 1 13 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 13 participants 14 participants
77
(77 to 77)
58
(35 to 73)
67.5
(35 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 13 participants 14 participants
Female
0
   0.0%
3
  23.1%
3
  21.4%
Male
1
 100.0%
10
  76.9%
11
  78.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
United States Number Analyzed 1 participants 13 participants 14 participants
1 13 14
1.Primary Outcome
Title Best Overall Response Rate (ORR) to Alisertib Alone
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 18 weeks (6 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 1 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0 [1] 
(NA to NA)
15
(2 to 45)
[1]
95% Confidence Interval was incalculable due to an insufficient number of events
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 6 weeks (2 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 0 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
8
(0 to 36)
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description 95% binomial confidence intervals calculated.
Time Frame 12 weeks (4 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected from the single participant in the "Cohort A (Alisertib, Rituximab)" Arm/Group therfore the 95% Confidence Interval was incalculable due to an insufficient number of events
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Response Rate(ORR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 18 weeks (6 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 1 13
Measure Type: Number
Unit of Measure: percentage of patients
0 15
5.Secondary Outcome
Title Complete Response Rate (CR)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 6 weeks (2 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 0 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 0)
6.Secondary Outcome
Title Complete Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 12 weeks (4 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected for participants in Cohort B (Alisertib, Rituximab)
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
NA [1] 
(NA to NA)
[1]
95% Confidence Interval was incalculable due to an insufficient number of events
7.Secondary Outcome
Title Overall Survival
Hide Description Graphically summarized using the methods of Kaplan and Meier.
Time Frame Time from study entry to the time of death due to any cause, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
data was not collected for participants in Cohort A
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 0 13
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(1.7 to 27.6)
8.Secondary Outcome
Title Progression-free Survival
Hide Description Graphically summarized using the methods of Kaplan and Meier.
Time Frame Time from study entry to the time of progression and/or death, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 1 13
Median (95% Confidence Interval)
Unit of Measure: months
2 [1] 
(NA to NA)
1.2
(.8 to 2.5)
[1]
95% Confidence Interval was incalculable due to an insufficient number of events
9.Secondary Outcome
Title Complete Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 18 weeks (6 courses)
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not collected and analyzed for this outcome measure
Arm/Group Title Cohort A (Alisertib, Rituximab) Cohort B (Alisertib, Rituximab)
Hide Arm/Group Description:

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

alisertib: Given PO

rituximab: Given IV

laboratory biomarker analysis: Laboratory correlative studies will be performed

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
 
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Cohort A: Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohort B: Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      10/13 (76.92%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      5/13 (38.46%)    
Blood and lymphatic system disorders     
Anemia  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Duodenal obstruction  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Abdominal pain  1  0/1 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Fatigue  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/1 (0.00%)  0 2/13 (15.38%)  2
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders     
Cystitis  1 [1]  0/1 (0.00%)  0 1/13 (7.69%)  1
Hematuria  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Pneumonitis  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Dyspnea  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Vascular disorders     
Thromboembolic event  1  0/1 (0.00%)  0 1/13 (7.69%)  1
1
Term from vocabulary, CTCAE version 4.0
Indicates events were collected by systematic assessment
[1]
noninfective
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      10/13 (76.92%)    
Blood and lymphatic system disorders     
Neutropenia  1  1/1 (100.00%)  1 4/13 (30.77%)  4
Lymphopenia  1  0/1 (0.00%)  0 4/13 (30.77%)  4
Thrombocytopenia  1  0/1 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Fatigue  1  0/1 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations     
Febrile Neutropenia  1  1/1 (100.00%)  1 0/13 (0.00%)  0
1
Term from vocabulary, CTCAE version 4.0
Indicates events were collected by systematic assessment
Study had slow patient enrollment and was discontinued after only 14 patients were enrolled.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kristie Blum, MD
Organization: The Ohio State University James Comprehensive Cancer Center
Phone: 614-293-7807
Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01812005     History of Changes
Other Study ID Numbers: OSU-12106
NCI-2012-02794 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 13, 2013
First Posted: March 15, 2013
Results First Submitted: March 21, 2017
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018