MDACC Study Summary ID02-229

Study Summary
No. ID02-229:.......Leukemia; Lymphoma......Susan O'Brien......Leukemia

Study Summary Title



Study Summary Number:	ID02-229

Study Title:	Rituximab and Hyper-CVAD for Burkitt's and Burkitt's-like (Small noncleaved cell) Leukemia or Lymphoma

Physician

New Patient Referral



Name:	Susan O'Brien	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7543 Contact us about clinical trials

General Information



Disease Group:	Leukemia Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Induction chemotherapy must be given at MDACC, then every 2-4 courses thereafter during intensive chemotherapy.

Treatment Agents:	Cyclophosphamide Cytarabine Dexamethasone Doxorubicin G-CSF Methotrexate Rituximab Vincristine	Home Care:	Intensive chemotherapy courses will be prescribed by M. D. Anderson physician or Principal Investigator. All chemotherapy treatment may be given by local oncologist except for the induction chemotherapy course.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	4 to 5 days for chemotherapy every 3 weeks; 21 to 28 days if in the protected environment for induction; 2-5 days if sepsis or other leukemia related events occur.


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

1. To determine the clinical efficacy and safety of rituximab and hyper-CVAD in newly diagnosed Burkitt's or Burkitt's-like (small noncleaved cell) leukemia or lymphoma

Study Status Information



Study Activation / Registration Date:	08/15/2002

IRB Review and Approval Date:	08/07/2002

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) All ages are eligible.

3) Zubrod performance status < 3 (ECOG Scale, Appendix A).

4) 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).

5) Signed informed consent.

Exclusion Criteria:

1) N/A

Links

Registration Number: NCT00669877
Study Information on Clinical Trials Registry (clinicaltrials.gov)