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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, January 2010

First Received: April 28, 2008 Last Updated: January 4, 2010 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	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, a monoclonal antibody. The safety of the combination therapy 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:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's-Like (Small Noncleaved Cell) Leukemia/Lymphoma

Resource links provided by NLM:

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

Primary Outcome Measures:

Number of patient with Complete Remission (CR) + Disease-free survival [ Time Frame: September 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	August 2002
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hyper-CVAD: Experimental	Drug: Rituximab Rituximab 375 mg/m2 IV Drug: Cyclophosphamide 300 mg/m2 IV Drug: Doxorubicin 50 mg/m2 IV Drug: Vincristine 2 mg IV Drug: Dexamethasone 40mg IV or by mouth (P.O.) Drug: G-CSF 10 mcg/kg Drug: Cytarabine 100 mg intrathecal Drug: Methotrexate 200 mg/m2 IV

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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

713-745-4616

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:	The University of Texas M. D. Anderson Cancer Center ( Susan O'Brien, M.D./Professor of Medicine )
Study ID Numbers:	ID02-229
Study First Received:	April 28, 2008
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00669877 History of Changes
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:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neoplasms, Experimental
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Rituximab
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Herpesviridae Infections
Virus Diseases
Neoplasms
DNA Virus Infections
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on February 08, 2010