Trial Outcomes & Findings for Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23) (NCT NCT01253460)
NCT ID: NCT01253460
Last Updated: 2019-09-06
Results Overview
Patients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
84 days
Results posted on
2019-09-06
Participant Flow
Recruitment Period: 8/22/2011 to 12/19/2013
Participant milestones
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)
Baseline characteristics by cohort
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
n=18 Participants
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 84 daysPatients evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] overall response criteria before course 4, then after every 2 courses, and at end of treatment (2 months after last course). Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Complete response is the absence of signs and symptoms, normalization of peripheral blood and bone marrow and lymph nodes 1.5 cm in diameter or smaller on CT scan. Partial response is at least 50% reduction in disease signs and symptoms, a 50% improvement in peripheral blood and greater than or equal to 50% reduction in lymph nodes.
Outcome measures
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
n=18 Participants
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Overall Response Rate (ORR)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 8.5 yearsTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
n=18 Participants
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Overall Survival
|
31 Months
Interval 2.0 to 92.0
|
Adverse Events
Cyclophosphamide, Rituximab + Sapacitabine
Serious events: 7 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
n=18 participants at risk
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Infections and infestations
Neutropenic Fever
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspena
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia Secondary to Chemotherapy
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Renal and urinary disorders
Renal Calculi
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Gastrointestinal disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Infections and infestations
Soft Tissue Infection
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
General disorders
Lymph node pain
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Nervous system disorders
Sycnope
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
Other adverse events
| Measure |
Cyclophosphamide, Rituximab + Sapacitabine
n=18 participants at risk
After Sapacitabine 350 mg orally Days 1-3, Cyclophosphamide 250 mg/m2 IV 2 hours, followed by Rituximab 375 mg/m2 IV Day 3, Course 1, and 500 mg/m2 Day 1, subsequent courses.
Cyclophosphamide: 250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
Rituximab: 375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
Sapacitabine: 350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
4/18 • Number of events 17 • Up to 8.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
12/18 • Number of events 48 • Up to 8.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.4%
8/18 • Number of events 33 • Up to 8.5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
General disorders
Chills
|
27.8%
5/18 • Number of events 5 • Up to 8.5 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
5/18 • Number of events 5 • Up to 8.5 years
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Blood and lymphatic system disorders
Edema, Limbs
|
22.2%
4/18 • Number of events 4 • Up to 8.5 years
|
|
Blood and lymphatic system disorders
Epistaxis
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
General disorders
Fever
|
22.2%
4/18 • Number of events 4 • Up to 8.5 years
|
|
General disorders
Headache
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Endocrine disorders
Hot Flashes
|
27.8%
5/18 • Number of events 5 • Up to 8.5 years
|
|
Investigations
Infusion Reaction
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 7 • Up to 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain, arthralgia
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
General disorders
Pain, Extremity
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
22.2%
4/18 • Number of events 4 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
2/18 • Number of events 2 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
3/18 • Number of events 3 • Up to 8.5 years
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
5.6%
1/18 • Number of events 1 • Up to 8.5 years
|
Additional Information
William G Wierda, MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place