MDACC Study Summary 2005-0206

Study Summary
No. 2005-0206:.......Hematologic Disorder......Srdan Verstovsek......Leukemia

Study Summary Title



Study Summary Number:	2005-0206

Study Title:	EVALUATION OF LENALIDOMIDE (CC-5013) AND PREDNISONE AS A THERAPY FOR PATIENTS WITH MYELOFIBROSIS (MF)

Physician

New Patient Referral



Name:	Srdan Verstovsek	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:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Monthly

Treatment Agents:	Lenalidomide	Home Care:	Self medicated

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied.

Study Objectives / Outcomes

Primary: To determine the efficacy of lenalidomide and prednisone in combination in patients with MF, in achieving objective improvements in disease status: complete and partial response, and hematological improvement.

Secondary: To determine the safety of lenalidomide and prednisone in combination, in patients with MF.

Tertiary: To examine pertinent morphological, biological, and molecular characteristics of MF in patient samples during therapy with lenalidomide and prednisone.

Study Status Information



Study Activation / Registration Date:	07/07/2006

IRB Review and Approval Date:	04/19/2006

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 myelofibrosis requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to Lille scoring system (risk factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 109/L; risk group: 0 factor(s) = low, 1 factor(s) = intermediate, 2 factor(s) = high) or with symptomatic splenomegaly

2) Understanding and voluntary signing an IRB-approved informed consent form.

3) Age >/= 18 years at the time of signing the informed consent.

4) Disease-free of prior malignancies for >/= 2-years with exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

5) ECOG performance status 0 to 2.

6) Patients must have adequate organ function as demonstrated by the following: Total bilirubin </= 2.0 mg/dL (unless higher due to MF); Serum creatinine </= 2.0 mg/dL (unless higher due to MF); Absolute neutrophil count >/= 1 x 10^9/L; ALT </= 3 x upper limit of normal (unless higher due to MF).

7) Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.

8) Continuation of 7. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods

9) footnote to no 7. † A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

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

Exclusion Criteria:

1) Use of any other standard (e.g. hydroxyurea, anagrelide, growth factors) or experimental drug or therapy within 28 days of starting lenalidomide and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.

2) Known prior clinically relevant hypersensitivity reaction to thalidomide, including the development of erythema nodosum if characterized by a desquamating rash.

3) Prior therapy with lenalidomide.

4) Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

5) Suspected Pregnancy. Pregnant or lactating females.

6) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

7) Known positive for HIV or infectious hepatitis, type A, B or C.

8) Known prior clinically relevant hypersensitivity to prednisone.

9) Participants with a heart rate (HR) of less than or equal to 50, as a HR less than 50 indicates underlying cardiac abnormalaties.

10) Participants with prior history of thromboembolic disease (i.e.-deep venous thrombosis [DVT] or pulmonary embolism [PE]) within the last six months, as Lenalidomide has demonstrated a significantly increased risk of DVT or PE.

Links

Registration Number: NCT00352794
Study Information on Clinical Trials Registry (clinicaltrials.gov)