MDACC Study Summary 2008-0075

Study Summary
No. 2008-0075:.......Lymphoma......Felipe Samaniego......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2008-0075

Study Title:	A Phase I/II Study of Immunotherapy with Milatuzumab (hLL1) in Patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Physician

New Patient Referral



Name:	Felipe Samaniego	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	Immunomedics, Inc

Phase of Study:	Phase I/Phase II	Return Visit:	Patient will need to come to MDACC weekly for 4 consecutive weeks; then 4 and 12 weeks later. Follow-up will be every 3 months as need for 2 years.

Treatment Agents:	Milatuzumab	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of milatuzumab that can be given to patients with CLL. The goal of the Phase II part of this clinical research study is to learn if milatuzumab can help to control CLL. The safety of the study drug will also be studied.

Study Objectives / Outcomes

1) The primary objectives are to evaluate the safety and tolerability of milatuzumab, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule).

2) The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

Study Status Information



Study Activation / Registration Date:	11/03/2008

IRB Review and Approval Date:	05/21/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	78

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) Male or female, age >/= 18 years.

2) Able to provide signed, informed consent.

3) Histologically confirmed or diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria).

4) Received at least one prior treatment for initial presentation of lymphoma (previous antibody therapy is acceptable).

5) Measurable disease (WBC > 5,000 for CLL).

6) Adequate performance status (>/= 70 Karnofsky scale) with an estimated life expectancy of at least 6 months.

7) Documented negative hepatitis B screen, per NCCN guidelines (hepatitis B surface antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen).

8) At least 12 weeks beyond stem cell transplant and 4 weeks beyond chemotherapy or immunotherapy, major surgery, other experimental treatments, or radiation therapy to the index lesions, and with all toxicities from prior therapy resolved to less than Grade 3 toxicity by NCI CTC version 3.0.

9) Laboratory parameters: Adequate hematology without ongoing transfusional support Hemoglobin >/= 8 g/dL; Absolute neutrophil count >/= 1.0 � 10^9/L; platelets >/= 50 � 10^9/L; Creatinine and bilirubin </= 1.5 x IULN; AST and ALT </= 2.5 x IULN.

Exclusion Criteria:

1) Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women.

2) Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion.

3) Prior therapy with other human or humanized monoclonal antibodies, unless human anti-human antibodies (HAHA) tested and negative.

4) Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter.

5) Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody. Patients with hepatitis B and HIV-1 infection.

6) Known autoimmune disease or presence of autoimmune phenomena.

7) At least 7 days beyond any infection requiring antibiotic use.

8) Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.

9) Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.

Links

Registration Number: NCT00603668
Study Information on Clinical Trials Registry (clinicaltrials.gov)