Leukemia and Myeloproliferative Disorders
Myelofibrosis
1
| Disease Status and/or Stage | Newly diagnosed or previously treated |
|---|---|
| Protocol Title | A Phase II, Prospective, Randomized, Multicenter, Double-Blind, Active-Control, Parallel Group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 either as Single Agent or in Combination with Prednisone to Study further in Subjects with Myelofibrosis with Myeloid Metaplasia |
| PI | Gail Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Subjects at least 18 years of age are eligible. Must be diagnosed with myelofibrosis requiring therapy. |
| Treatment Overview |
Subjects will be randomized into one of 4 treatment arms to receive either 2 mg CC-4047+ prednisone placebo, 2 mg CC-4047 with prednisone, 0.5 mg CC-4047 with prednisone, or prednisone + CC-4047 placebo. Subjects will remain on study treatment in the Double Blind Treatment Phase for up to 12 cycles (336 days; 12 cycles of 28 days each). |
2
| Disease Status and/or Stage | Newly diagnosed or previously treated |
|---|---|
| Protocol Title | An Open-Label Study of Oral CEP-701 in Patients with Polycythemia Vera or Essential Thrombocytosis with the JAK2 V617F Mutation. |
| PI | Gail Roboz, MD |
| Contact | Mary Crann, RN 212-746-1480 |
| Key Eligibility | Subjects at least 18 years of age are eligible. Patients must have a detectable JAK2 mutation. Subjects with ET must be receiving concomitant hydroxyurea. |
| Treatment Overview | Patients will be administerd a dose of 80 mg bid starting on study day 1 at the baseline visit and will continue receiving treatment until day 126. Patients will participate in an 18-week treatment period with a 2-week follow-up period. Patients who participate in this study may elect to continue receiving treatment with CEP-701 by entering into the extension period after the visit at week 18. |
3
| Disease Status and/or Stage | Advanced Myelofibrosis or Transformed to AML |
|---|---|
| Protocol Title | Prospective Pilot Trial of Arsenic Trioxide (Trisenox) in Combination with Cytosine Arabinoside (Cytarabine) in Patients with Advanced or Transformed Myelofibrosis |
| PI | Gail Roboz, MD |
| Contact | Tania Curcio, RN 212-746-2571 |
| Key Eligibility | Patients at least 18 years of age with a documented history of myelofibrosis or myelofibrosis transformed to acute myeloid leukemia. Patients must not have had prior cytotoxic chemotherpy for AML or MDS. |
| Treatment Overview | Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously twice daily from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of Trisenox. Patients may continue to receive study treatment for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated. |
4
| Disease Status and/or Stage | Previously Treated or Newly Diagnosed Myelofibrosis |
|---|---|
| Protocol Title | Phase II Study of Bevacizumab (AvastinŽ) in Myelofibrosis (MPD-RC-103) |
| PI | Ellen Ritchie, MD |
| Contact | Mary Crann, RN 212-746-1480 |
| Key Eligibility | Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis, or polycythemia vera related myelofibrosis requiring therapy, including those previously treated and relapsed or refractory, or, if newly diagnosed, with intermediate or high risk. |
| Treatment Overview | Bevacizumab will be given in the outpatient setting as an intravenous infusion (IV) every 3 weeks at the dose of 15 mg/kg. A 3 weeks period is considered one course. Subjects may be enrolled in the study for approximately 18 months. |
5
| Disease Status and/or Stage | Previously Treated or Newly Diagnosed Myelofibrosis |
|---|---|
| Protocol Title | A Multicenter, Open-Label, Phase I/II Study of CEP-701 (Lestaurtinib) in Adults with Myelofibrosis (MPD-RC-104) |
| PI | Gail Roboz, MD |
| Contact | Mary Crann, RN 212-746-1480 |
| Key Eligibility | Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis, or polycythemia vera related myelofibrosis requiring therapy. |
| Treatment Overview | Cohorts of 3 subjects will receive escalating doses of CEP-701 until the Maximum Tolerated Dose is determined. Dosing will begin at 80 mg twice a day. Subjects may receive study drug for 24 weeks or longer depending on response. |
Last updated: July 25, 2008 |
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