Overview

Ruxolitinib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Status:
Completed

Trial end date:
2019-04-02

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given to patients with low or intermediate-1 risk MDS. The safety of this drug will also be studied, and whether it can help to control the disease.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Incyte Corporation

Criteria

Inclusion Criteria:

1. Patients with previously treated low or intermediate-1 risk MDS by the IPSS
classification (this is defined in table 1)

2. Patients must have one of the following: elevated b2-microglobulin levels (defined as
2 times compared to normal), carry a JAK2 mutation, or presence of phosphorylated p65
NF-kB component in at least 5% of bone marrow cells.

3. Signed informed consent indicating that patients are aware of the investigational
nature of this study in keeping with the policies of UTMDACC.

4. Age >/= 18 years old

5. Prior therapy with growth factor support, lenalidomide, 5-azacytidine, decitabine or
other investigational agents are allowed. A four week wash out period will be required
before receiving study medication.

6. Patients must have the following non-hematologic values Aspartate aminotransferase
(AST/SGOT) and alanine aminotransferase (ALT/SGPT) (ULN) or Serum creatinine /= 60 ml/min

7. Patients with Childbearing potential must agree to use appropriate forms of birth
control

Exclusion Criteria:

1. Previously untreated low or intermediate-1 risk MDS patients because there are
approved therapies for these patients.

2. Uncontrolled undercurrent illness that in the opinion of the treating physician would
contraindicate the use of the drug.

3. Patients with active infections including uncontrolled HIV infection, active hepatitis
B, C, or any other symptomatic systemic infection requiring active therapy will be
excluded from study

4. Patients receiving potent CYP3A4 (such as but not limited to boceprevir,
clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole,
lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir,
saquinavir, telaprevir, telithromycin, voriconazole) inhibitors will be excluded from
the study.

5. Women who are pregnant or lactating.

6. Patients with a white blood cell count of more than 30x10^3 K/uL will not be eligible
for this study.

7. Patients that have received prior allogeneic stem cell transplantation are excluded
from this study.