Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00669877

Purpose

The goal of this clinical research study is to learn if intensive chemotherapy given over 6 months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment works when given with Rituximab. The safety of the combined treatment will also be studied.

Condition	Intervention	Phase
Burkitt's Lymphoma Burkitt'S-like Lymphoma	Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: G-CSF Drug: Cytarabine Drug: Methotrexate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Complete Remission (CR) + Disease-Free Survival [ Time Frame: After two 21-day courses ] [ Designated as safety issue: Yes ]
After two courses of therapy, response to treatment checked for: 1) Complete Remission (CR) or 2) Disease-free survival (time from documented CR until relapse or death).

Estimated Enrollment:	70
Study Start Date:	August 2002
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Hyper-CVAD Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses	Drug: Rituximab 375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Other Name: Rituxan Drug: Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses). Other Names: Cytoxan Neosar Drug: Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Other Names: Adriamycin Rubex Drug: Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses) Other Names: Oncovin Vincasar Pfs Drug: Dexamethasone 40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses) Other Name: Decadron Drug: G-CSF 10 mcg/kg Other Names: Filgrastim Neupogen Drug: Cytarabine 100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses). Other Names: Ara-C Cytosar DepoCyt Cytosine Arabinosine Hydrochloride Drug: Methotrexate 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab. Other Names: Rheumatrex Methotrexate Sodium, MTX

Arms

Assigned Interventions

Experimental: Hyper-CVAD

Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses

Drug: Rituximab

375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses.

Other Name: Rituxan

Drug: Cyclophosphamide

300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses).

Other Names:

Cytoxan
Neosar

Drug: Doxorubicin

50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).

Other Names:

Adriamycin
Rubex

Drug: Vincristine

2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses)

Other Names:

Oncovin
Vincasar Pfs

Drug: Dexamethasone

40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses)

Other Name: Decadron

Drug: G-CSF

10 mcg/kg

Other Names:

Filgrastim
Neupogen

Drug: Cytarabine

100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).

Other Names:

Ara-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride

Drug: Methotrexate

200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.

Other Names:

Rheumatrex
Methotrexate Sodium, MTX

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated, previously treated (may be in CR or with active disease after 1-2 courses of chemotherapy), or HIV-related.
All ages are eligible.
Zubrod performance status < 3 (ECOG Scale, Appendix A).
Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).
Signed informed consent.

Exclusion Criteria:

1) N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669877

Contacts

Contact: Susan O'Brien, MD

713-792-7543

sobrien@mdanderson.org

Locations

United States, Texas
The University of Texas M. D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Susan O'Brien, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00669877 History of Changes
Other Study ID Numbers:	ID02-229
Study First Received:	April 28, 2008
Last Updated:	December 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Burkitt's Lymphoma
Burkitt's Like Lymphoma
Leukemia
Hyper-CVAD

Rituximab
Methotrexate
Cytarabine

Additional relevant MeSH terms:

Burkitt Lymphoma
Leukemia
Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Rituximab
Dexamethasone
Doxorubicin
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012