MDACC Study Summary 2005-0552

Study Summary
No. 2005-0552:.......Leukemia......Stefan Faderl......Leukemia

Study Summary Title



Study Summary Number:	2005-0552

Study Title:	Phase I/II Study of Clofarabine plus Cyclophosphamide for Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

Physician

New Patient Referral



Name:	Stefan Faderl	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:	713-745-4613 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Induction chemotherapy and all subsequent courses must be given at MDACC.

Treatment Agents:	Clofarabine Cyclophosphamide	Home Care:	Chemotherapy courses will be prescribed and administered at MD Anderson only. Patients can be followed by referring physician in between courses.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Minimum of 28 days for course 1 of each cohort.


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of the drugs clofarabine and cyclophosphamide that can be given together in the treatment of relapsed or refractory ALL. The safety of the combination treatment will also be studied.

Study Objectives / Outcomes

Phase I:

1. To establish toxicities and safety of the proposed combination

2. To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination to proceed with the phase II part of the study

Phase II:

3. To establish the efficacy (complete and overall response) of the proposed combination.

4. To analyze pharmacokinetic (PK) and pharmacodyamic (PD) properties of clofarabine as well as the impact on DNA repair of leukemic blasts with the proposed combination.

Study Status Information



Study Activation / Registration Date:	03/21/2006

IRB Review and Approval Date:	09/07/2005

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) Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. For patients in first relapse, the first remission duration may not exceed 12 months.

2) Age >/= 21 years.

3) Zubrod performance status </= 3.

4) Adequate liver function (bilirubin </= 2.5 mg/dL and SGPT or SGOT </= 3 x ULN, unless considered due to tumor), and renal function (glomerular filtration rate [GFR] >/= 60 mL/min). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 5 mg/dL and creatinine </= 3 mg/dL.

5) Male and female patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test witin 14 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

1) Patients with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).

2) Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.

3) Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. (Concurrent therapy for CNS prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition following discussion with the Principal Investigator.

4) Pregnant and breast-feeding patients are excluded

Links

Registration Number: NCT00412243
Study Information on Clinical Trials Registry (clinicaltrials.gov)