MDACC Study Summary ID02-230

Study Summary
No. ID02-230:.......Leukemia; Lymphoma......Susan O'Brien......Leukemia

Study Summary Title



Study Summary Number:	ID02-230

Study Title:	Phase II Study of the Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia

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 M. D. Anderson, then every 2-4 courses thereafter during intensive chemotherapy.

Treatment Agents:	Asparaginase Cyclophosphamide Cytarabine Dexamethasone Doxorubicin G-CSF Methotrexate Pegfilgrastim 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 (overall response rate, remission duration or time to progression) and safety of a modified version of an intensive short-term chemotherapy regimen (Hyper-CVAD program) in newly diagnosed acute lymphoblastic leukemia (ALL) patients.

Study Status Information



Study Activation / Registration Date:	11/13/2002

IRB Review and Approval Date:	05/15/2002

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) Newly diagnosed, previously untreated ALL or lymphoblastic lymphoma, or having achieved CR with one course of induction chemotherapy.

2) Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.

3) All ages are eligible.

4) Zubrod performance less than or equal to 3

5) 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).

6) Adequate cardiac function as assessed by history and physical examination.

7) No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1) N/A

Links

Registration Number: NCT00671658
Study Information on Clinical Trials Registry (clinicaltrials.gov)