MDACC Study Summary 2007-0199

Study Summary
No. 2007-0199:.......Leukemia; Myeloproliferative Diseases......Srdan Verstovsek......Leukemia

Study Summary Title



Study Summary Number:	2007-0199

Study Title:	A phase II, prospective, open label study (PO-MMM-PI-0011) to determine the safety and efficacy of pomalidomide (CC-4047) in subjects with primary, post polycythemia vera, or post essential thrombocythemia myelofibrosis (PMF; post-PV MF, or post-ET 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:	Leukemia Myeloproliferative Diseases	Supported By:	Celgene

Phase of Study:	Phase II	Return Visit:	Study visits will occur at least every 28 days for 3 months, then can be extended to every 3 months if patient hasn't had any Grade 3-4 toxicity during the previous 3 months.

Treatment Agents:	CC 4047 Prednisone	Home Care:	N/A

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 CC-4047 and predinisone can help to control MMM. The safety of this therapy will also be studied.

Study Objectives / Outcomes

Primary:

· To determine the effect of CC-4047 and prednisone in the treatment of Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF)
· To determine the safety of CC-4047 and prednisone in the treatment of Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF)

Secondary:

To further explore the nature and quality of responses to CC-4047 and prednisone

Study Status Information



Study Activation / Registration Date:	07/22/2009

IRB Review and Approval Date:	12/04/2007

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) Must be >/= 18 years of age at the time of voluntarily signing an Institutional Review Board/Independent Ethics Committee (IRB/IEC) – approved informed consent form.

2) Must be diagnosed with myelofibrosis requiring therapy including myelofibrosis with myeloid metaplasia (MMM), de novo presentation (i.e. agnogenic myeloid metaplasia [AMMM], and developing after an antecedent history of Polycythemia vera (i.e., post-polycythemic myeloid metaplasia [PPMM]), or essential Polycythemia (i.e., post thrombocythemic myeloid metaplasia [PTMM]).

3) Screening total hemoglobin level < 10 g/dL or transfusion-dependent anemia defined as per IWG criteria (transfusion dependency defined by a history of a least 2 units of red blood cell transfusions in the last 28 days for hemoglobin < 8.5 g/dL that was not associated with overt bleeding)

4) Must have adequate organ function as demonstrated by the following </= 14 days prior to starting study drug: ·ALT (SGOT) and AST (SGPT) </= 3 x upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH)] ·Total bilirubin < 3 x ULN or Direct Bilirubin < 2 x ULN ·Serum creatinine </= 2.5 mg/dL ·Absolute neutrophil count >/= 1,000/µL (>/=1.0 x 10^9/L) ·Platelet count >/= 50,000/µL (>/=50 x 10^9/L)

5) Subjects must be willing to receive transfusion of blood products

6) ECOG performance status (PS) of 0, 1, or 2 at screening.

7) Must be willing to adhere to the study visit schedule and other protocol requirements.

8) No active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma (in situ) of the cervix or breast

9) Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or abstinence from intercourse during the following time periods: At least 28 days before starting study drug While participating in the study For at least 28 days after discontinuation from the study. Two methods of reliable contraception must include one highly effective method, hormonal pills, injections, or implants, tubal ligation, partner's vasectomy and one additional effective method (i.e. latex condom, diaphragm, cervical cap)

Exclusion Criteria:

1) Known positive status for HIV, hepatitis B carrier, or active hepatitis C infection.

2) The use of any growth factors, cytotoxic chemotherapeutic agents (e.g. hydroxyurea), corticosteroids, or experimental drug or therapy within 14 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.

3) Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or 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.

4) Pregnant or lactating females

5) Prior use of CC-4047

6) Currently enrolled on another clinical trial or receiving investigational agent

Links

Registration Number: NCT00946270
Study Information on Clinical Trials Registry (clinicaltrials.gov)