MDACC Study Summary 2011-0509

Study Summary
No. 2011-0509:.......Leukemia; Lymphoma......Alessandra Ferrajoli......Leukemia

Study Summary Title



Study Summary Number:	2011-0509

Study Title:	Combination of Lenalidomide and Rituximab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) as Initial Treatment or Subsequent Therapy

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:	Leukemia Lymphoma	Supported By:	Celgene Corp.

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Lenalidomide Rituximab	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 the combination of
lenalidomide and rituximab can help to control CLL. The safety of this drug
combination will also be studied.

Lenalidomide is designed to change the body's immune system. It may also
interfere with the development of tiny blood vessels that help support tumor
growth. This may decrease the growth of cancer cells.

Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.

Study Objectives / Outcomes

The primary objective is to evaluate the efficacy of the combination of lenalidomide and rituximab in patients with chronic lymphocytic leukemia that have received prior therapy and in patients with chronic lymphocytic leukemia that have not been previously treated and are 65 years of age or older.

The secondary objective of this study is safety of this combination.

The third objective will be response according to disease characteristics, such as IgVH mutation status, FISH hierarchy and other translational research markers.

Study Status Information



Study Activation / Registration Date:	12/12/2011

IRB Review and Approval Date:	12/12/2011

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) Age >/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent.

2) Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.

3) ECOG/WHO performance status of 0-2.

4) Adequate renal function indicated by serum creatinine less or equal to 2mg/dL

5) Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal.

6) Disease free of prior malignancies for 3 years with exception of current basal cell, squamous cell cafrcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.

7) All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the program requirements.

8) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL witthin 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1. Prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use two acceptable methods of birth control, one highly effective method and one additional effective method at the same time at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.

Exclusion Criteria:

1) Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.

2) Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).

3) Known positivity for HIV or active hepatitis B or C.

4) Pregnant or breast feeding females.

5) History of tuberculosis treated within the last five years or recent exposure to tuberculosis.

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) Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to enrollment are not eligible for the study.

Links

Registration Number: NCT01446133
Study Information on Clinical Trials Registry (clinicaltrials.gov)