Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma (NCT NCT00392834)
NCT ID: NCT00392834
Last Updated: 2018-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
1 year post treatment
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Regimen A (R-CODOX-M Chemotherapy)
Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
|
Regimen B (Rituximab and IVAC Chemotherapy)
Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
32
|
|
Overall Study
COMPLETED
|
2
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma
Baseline characteristics by cohort
| Measure |
Regimen A (R-CODOX-M Chemotherapy)
n=2 Participants
Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
|
Regimen B (Rituximab and IVAC Chemotherapy)
n=32 Participants
Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
32 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post treatmentOutcome measures
| Measure |
Regimen A (R-CODOX-M Chemotherapy)
n=2 Participants
Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
|
Regimen B (Rituximab and IVAC Chemotherapy)
n=32 Participants
Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
|
|---|---|---|
|
Overall Survival (OS) at 1 Year
|
1.0 Cumulative proportion surviving at 1 yr
Interval 1.0 to 1.0
|
0.82 Cumulative proportion surviving at 1 yr
Interval 0.62 to 0.92
|
SECONDARY outcome
Timeframe: 6-8 weeks post treatment, every 4 months post-treatment for 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-8 weeks post treatment, every 4 months post-treatment for 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-8 weeks post treatment, every 4 months post-treatment for 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 2 years post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 2 years post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 2 years post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 6-8 weeks post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baselineOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 2 years post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 2 years post-treatmentOutcome measures
Outcome data not reported
Adverse Events
Regimen A (R-CODOX-M Chemotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen B (Rituximab and IVAC Chemotherapy)
Serious events: 23 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A (R-CODOX-M Chemotherapy)
n=2 participants at risk
Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
|
Regimen B (Rituximab and IVAC Chemotherapy)
n=32 participants at risk
Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2
|
12.5%
4/32 • Number of events 7
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2
|
18.8%
6/32 • Number of events 8
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Ear and labyrinth disorders
Extraocular muscle paresis
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
General disorders
Death NOS
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infections and infestations, other
|
0.00%
0/2
|
12.5%
4/32 • Number of events 5
|
|
Infections and infestations
Lung infection
|
0.00%
0/2
|
9.4%
3/32 • Number of events 4
|
|
Infections and infestations
Sepsis
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Skin infection
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Cardiac tropinin I increased
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2
|
3.1%
1/32 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2
|
18.8%
6/32 • Number of events 11
|
|
Investigations
Platelet count decreased
|
0.00%
0/2
|
28.1%
9/32 • Number of events 13
|
|
Investigations
White blood cell decreased
|
0.00%
0/2
|
25.0%
8/32 • Number of events 17
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2
|
3.1%
1/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2
|
3.1%
1/32 • Number of events 2
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Transient ischemia attach
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2
|
3.1%
1/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/2
|
3.1%
1/32 • Number of events 2
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
Other adverse events
| Measure |
Regimen A (R-CODOX-M Chemotherapy)
n=2 participants at risk
Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
|
Regimen B (Rituximab and IVAC Chemotherapy)
n=32 participants at risk
Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2
|
46.9%
15/32 • Number of events 34
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2
|
9.4%
3/32 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2
|
6.2%
2/32 • Number of events 3
|
|
Gastrointestinal disorders
Oral mucositis
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
12.5%
4/32 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
15.6%
5/32 • Number of events 7
|
|
General disorders
Pain
|
0.00%
0/2
|
9.4%
3/32 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2
|
12.5%
4/32 • Number of events 9
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2
|
18.8%
6/32 • Number of events 14
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2
|
9.4%
3/32 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2
|
6.2%
2/32 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2
|
43.8%
14/32 • Number of events 26
|
|
Investigations
Platelet count decreased
|
0.00%
0/2
|
50.0%
16/32 • Number of events 39
|
|
Investigations
Weight loss
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2
|
28.1%
9/32 • Number of events 41
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2
|
21.9%
7/32 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/2
|
12.5%
4/32 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2
|
25.0%
8/32 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2
|
12.5%
4/32 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2
|
15.6%
5/32 • Number of events 10
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
12.5%
4/32 • Number of events 5
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2
|
9.4%
3/32 • Number of events 5
|
Additional Information
Jeannette Lee, Ph.D.
University of Arkansas for Medical Sciences
Phone: 501-526-6712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place