Trial Outcomes & Findings for Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (NCT NCT01812005)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 18 weeks (6 courses)

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (Alisertib, Rituximab) 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	Cohort B (Alisertib, Rituximab) 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 Study STARTED	1	13
Overall Study COMPLETED	1	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A (Alisertib, Rituximab) n=1 Participants 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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 n=14 Participants Total of all reporting groups
Age, Continuous	77 years n=5 Participants	58 years n=7 Participants	67.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	1 patients n=5 Participants	13 patients n=7 Participants	14 patients n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks (6 courses)

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.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) n=1 Participants 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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
Best Overall Response Rate (ORR) to Alisertib Alone	0 percentage of patients 95% Confidence Interval was incalculable due to an insufficient number of events	15 percentage of patients Interval 2.0 to 45.0

SECONDARY outcome

Timeframe: 6 weeks (2 courses)

Population: 2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug

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.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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 Response Rate (ORR)	—	8 percentage of patients Interval 0.0 to 36.0

SECONDARY outcome

Timeframe: 12 weeks (4 courses)

Population: 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

95% binomial confidence intervals calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks (6 courses)

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.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) n=1 Participants 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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 Response Rate(ORR)	0 percentage of patients	15 percentage of patients

SECONDARY outcome

Timeframe: 6 weeks (2 courses)

Population: 2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug

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.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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
Complete Response Rate (CR)	—	0 percentage of patients Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 12 weeks (4 courses)

Population: data was not collected for participants in Cohort B (Alisertib, Rituximab)

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.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) n=1 Participants 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	Cohort B (Alisertib, Rituximab) 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
Complete Response Rate	NA percentage of patients 95% Confidence Interval was incalculable due to an insufficient number of events	—

SECONDARY outcome

Timeframe: Time from study entry to the time of death due to any cause, assessed up to 1 year

Population: data was not collected for participants in Cohort A

Graphically summarized using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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 Survival	—	3.1 months Interval 1.7 to 27.6

SECONDARY outcome

Timeframe: Time from study entry to the time of progression and/or death, assessed up to 1 year

Graphically summarized using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Cohort A (Alisertib, Rituximab) n=1 Participants 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	Cohort B (Alisertib, Rituximab) n=13 Participants 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
Progression-free Survival	2 months 95% Confidence Interval was incalculable due to an insufficient number of events	1.2 months Interval 0.8 to 2.5

SECONDARY outcome

Timeframe: 18 weeks (6 courses)

Population: The data was not collected and analyzed for this outcome measure

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.

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort B

Serious events: 5 serious events

Other events: 10 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=1 participants at risk 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 n=13 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Gastrointestinal disorders Duodenal obstruction	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Blood and lymphatic system disorders Anemia	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
General disorders Fatigue	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Metabolism and nutrition disorders Dehydration	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	15.4% 2/13 • Number of events 2 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Gastrointestinal disorders Abdominal pain	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Vascular disorders Thromboembolic event	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Renal and urinary disorders Cystitis	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Renal and urinary disorders Hematuria	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients

Other adverse events

Other adverse events
Measure	Cohort A n=1 participants at risk 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 n=13 participants at risk 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.
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	30.8% 4/13 • Number of events 4 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	30.8% 4/13 • Number of events 4 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
Infections and infestations Febrile Neutropenia	100.0% 1/1 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	0.00% 0/13 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients
General disorders Fatigue	0.00% 0/1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients	7.7% 1/13 • Number of events 1 The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients

Additional Information

Kristie Blum, MD

The Ohio State University James Comprehensive Cancer Center

Phone: 614-293-7807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place