Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

AIDS Malignancy Clinical Trials Consortium

ClinicalTrials.gov Identifier:

NCT00392834

First received: October 25, 2006

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Results First Received: January 24, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lymphoma
Interventions:	Biological: filgrastim Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: liposomal cytarabine Drug: methotrexate Drug: therapeutic hydrocortisone Drug: vincristine sulfate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

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.

Participant Flow: Overall Study

	Regimen A (R-CODOX-M Chemotherapy)	Regimen B (Rituximab and IVAC Chemotherapy)
STARTED	2	32
COMPLETED	2	32
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Regimen A (R-CODOX-M Chemotherapy)	Regimen B (Rituximab and IVAC Chemotherapy)	Total
Number of Participants [units: participants]	2	32	34
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	2	32	34
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	41 ± 8.5	41.4 ± 9.4	41.4 ± 9.2
Gender [units: participants]
Female	0	4	4
Male	2	28	30
Region of Enrollment [units: participants]
United States	2	32	34

Outcome Measures

1. Primary:

Overall Survival (OS) at 1 Year [ Time Frame: 1 year post treatment ]

Show Outcome Measure 1

2. Secondary:

Complete Response Rate [ Time Frame: 6-8 weeks post treatment, every 4 months post-treatment for 2 years ]