Chronic Myeloproliferative Disorders Clinical Trial
Official title:
A Phase I/II, Prospective, Open-Label Study to Determine the Safety and Efficacy of CC-4047 in Patients With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis®
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in
different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer
cells by blocking blood flow to the cancer.
PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well
it works in treating patients with myelofibrosis.
OBJECTIVES:
Phase I:
Primary
- To determine the Maximum Tolerated Dose of CC-4047 in the treatment of Primary, Post
Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or
post-ET MF).
Phase II:
Primary
- Best overall response as determined by International Working Group Criteria over the
first 6 cycles (168 days) of study treatment.
Secondary
- Safety (type, frequency, severity [National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 3.0] of adverse events (AEs), and
relationship of AEs to CC-4047.
- Duration of response.
- Time to response.
- Best overall response as determined by International Working Group Criteria over the
first 12 cycles (336 days) of study treatment.
OUTLINE: Patients receive oral CC-4047. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then every 6 months
for up to 3 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01164163 -
INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease
|
Phase 1 | |
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Withdrawn |
NCT00816413 -
Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00437086 -
Bortezomib in Treating Patients With Advanced Myeloproliferative Disorders
|
Phase 0 | |
| Completed |
NCT00951626 -
A Standardized Nursing Intervention Protocol for HCT Patients
|
N/A | |
| Terminated |
NCT00005641 -
Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
|
Phase 2 | |
| Active, not recruiting |
NCT00755040 -
Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder
|
Phase 3 | |
| Completed |
NCT00719563 -
American Ginseng in Treating Patients With Fatigue Caused by Cancer
|
Phase 3 | |
| Terminated |
NCT00899951 -
Studying Fentanyl in Patients With Cancer
|
N/A | |
| Active, not recruiting |
NCT00448357 -
Fludarabine and PK-Directed Busulfan With or Without ATG Followed By Donor Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
|
Phase 1/Phase 2 | |
| Completed |
NCT00274820 -
Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Myelofibrosis/Myeloproliferative Disorder
|
Phase 2 | |
| Completed |
NCT00293384 -
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
|
N/A | |
| Completed |
NCT00445900 -
Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia
|
Phase 2 | |
| Completed |
NCT00134004 -
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
|
Phase 2 | |
| Completed |
NCT00054340 -
Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
|
Phase 1/Phase 2 | |
| Completed |
NCT00006348 -
Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
|
Phase 3 | |
| Completed |
NCT00004232 -
Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
|
Phase 1 | |
| Terminated |
NCT00290628 -
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
|
N/A | |
| Completed |
NCT00005804 -
Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 |