MDACC Study Summary 2011-0520

Study Summary
No. 2011-0520:.......Advanced Cancers; Leukemia......Alessandra Ferrajoli......Leukemia

Study Summary Title



Study Summary Number:	2011-0520

Study Title:	Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients with Chronic Lymphocytic Leukemia (CLL)

Physician

New Patient Referral



Name:	Alessandra Ferrajoli	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:	713-792-2063 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Leukemia	Supported By:	National Comprehensive Cancer Network

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Ofatumumab	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied. Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.

Study Objectives / Outcomes

Primary Objective:

1. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with CLL.

Secondary Objective:

1. To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.
2. To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.
3. To determine the plasma levels of ofatumumab in elderly, unfit patients.
4. To evaluate predictive capability of miRNAs detection in plasma samples

Study Status Information



Study Activation / Registration Date:	12/15/2011

IRB Review and Approval Date:	12/15/2011

Study Type:	Phase Ii Or Phase I/Ii

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) Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.

2) ECOG/WHO performance status of 2-3.or patients with chronic lymphocytic leukemia requiring treatment age >65 years at the time of signing informed consent and ECOG/WHO performance status of 0-1 and a CIRS or Charlson co-morbidity score of 2 or higher.

3) Adequate renal and hepatic function (creatinine <2mg/dL and eGFR more than 30cc/minute, bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible.

Exclusion Criteria:

1) Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

2) Known positivity for HIV.

3) Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.

4) Prior treatment for chronic lymphocytic leukemia.

5) Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.

6) Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.

7) Any known hypersensitivity to ofatumumab or its components.

Links

Registration Number: NCT01444716
Study Information on Clinical Trials Registry (clinicaltrials.gov)