MDACC Study Summary 2004-0408 (Archived)

Study Summary
No. 2004-0408:.......Leukemia; Lymphoma......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2004-0408

Study Title:	A phase II study of alemtuzumab and pentostatin in T-cell neoplasms

Physician

New Patient Referral



Name:	Farhad Ravandi-Kashani	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:	713-745-0394 Contact us about clinical trials

General Information



Disease Group:	Leukemia Lymphoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Three times weekly for the first three months then every 2 weeks. AFter the first 4 weeks of therapy both agents (alemtuzumab and pentostatin) may be administered by the local oncologists.

Treatment Agents:	Campath-1H Deoxycoformycin	Home Care:	After the first 4 weeks of therapy both agents (alemtuzumab and pentostatin) may be adminstered by the local oncologists (for a maximum of 2 further months of therapy with alemtuzumab and 5 further months of therapy with pentostatin).

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospitalization is required for administration of the drugs.


Description/ Intervention:	The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.

Study Objectives / Outcomes

1. To demonstrate the efficacy in achieving objective response (CR+PR) of combination of pentostatin administered intravenously weekly for 4 weeks then every two weeks in addition (concurrently) to alemtuzumab three times weekly until best response in patients with T-lymphoid neoplasms and in improving the duration of response achieved historically with either agent alone.

2. To assess the toxicity of this combination.

3. To examine the effect of addition of alemtuzumab to pentostatin on the long-term disease-free (DFS) and overall survival (OS)(as compared with historical controls).

Study Status Information



Study Activation / Registration Date:	09/28/2004

IRB Review and Approval Date:	08/24/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

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) Age 18 years and older

2) Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or tissue (skin, lymph node or other) examination and using the standard criteria.

3) Patients with untreated T-PLL, peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.

4) Patients with relapsed/refractory T-PLL, T-ALL, ATLL, peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma and other T-lymphoid malignancies are eligible. Patients who have had prior therapy with either alemtuzumab or pentostatin as single agents are eligible.

5) Willing to use adequate contraception for the entire duration of the study.

6) Performance status 0-2.

7) Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance greater than 40

8) Bilirubin less than or equal to 3.0 mg/dL, transaminases (SGPT, SGOT) less than 4 x upper limit of normal unless related to the disease.

9) Left ventricular ejection fraction greater than 30%.

Exclusion Criteria:

1) Unable or unwilling to sign the consent form.

2) Pregnant or lactating

3) Known to be HIV+

4) Active and uncontrolled infection as judged by treating physician

Links

Registration Number: NCT00453193
Study Information on Clinical Trials Registry (clinicaltrials.gov)