Overview

Pomalidomide for Myelofibrosis Patients

Status:
Completed

Trial end date:
2018-05-22

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and prednisone can help to control MMM. The safety of this therapy will also be studied.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Celgene

Treatments:

Pomalidomide
Prednisone
Thalidomide

Criteria

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 International Working Group (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 to starting study drug: ·Alanine transaminase (ALT) (SGOT) and Aspartate
aminotransferase (AST) (SGPT) 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 /= 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. Eastern Cooperative Oncology Group (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. All study participants must be registered into the mandatory POMALYST REMS™ program,
and be willing and able to comply with the requirements of the POMALYST REMS™ program.

10. Females of reproductive potential (FCBP†) must adhere to the scheduled pregnancy
testing as required in the POMALYST REMS™ program. Able to take aspirin (81 or 325 mg)
daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or
low molecular weight heparin).

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