MDACC Study Summary 2010-0266

Study Summary
No. 2010-0266:.......Leukemia......William G. Wierda......Leukemia

Study Summary Title



Study Summary Number:	2010-0266

Study Title:	Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Physician

New Patient Referral



Name:	William G. Wierda	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:	713-745-0428 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	GlaxoSmithKline

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 find out if ofatumumab can control CLL or SLL that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be studied.

Study Objectives / Outcomes

Primary:
Response rate (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR) with ofatumumab treatment in patients with residual disease.

Secondary:
Determine the time-to-treatment failure and progression-free survival.
Determine the time-to-next chronic lymphocytic leukemia (CLL) treatment after ofatumumab
Evaluate the safety and tolerability of ofatumumab for residual disease.
Evaluate the pharmacokinetics of ofatumumab in this trial for residual disease and in maintenance.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/06/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

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) Diagnosis of CD20+ chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with chemotherapy or chemoimmunotherapy: Post-frontline therapy, patients must have non-progressing disease and be 4 months to 1 year post treatment. Post-treatment for relapsed CLL, eligible patients must have non-progressing disease and be 3 months to 1 year post treatment.

2) Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry.

3) Adequate renal and hepatic function (creatinine < 2 mg/dL, bilirubin < 2 mg/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.

4) Age >/= 18 years.

5) ECOG performance status of 0-2.

6) Provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the MDACC IRB.

7) Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study.

Exclusion Criteria:

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

2) Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not comprising bone marrow function does not apply.

3) Active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with CLL or stable chronic liver disease per investigator assessment).

4) Pregnant and breastfeeding females are excluded.

Links

Registration Number: NCT01258933
Study Information on Clinical Trials Registry (clinicaltrials.gov)