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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00806598 |
Purpose
The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe AA or hypoplastic MDS. The safety of this combination therapy will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Aplastic Anemia |
Drug: Thymoglobulin Drug: Cyclosporine Drug: Methylprednisolone Drug: G-CSF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and GCSF in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Thymoglobulin + Cyclosporin
Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF
|
Drug: Thymoglobulin
3.5 or 2.5 mg/kg/day IV for 5 days
Other Names:
Drug: Cyclosporine
5 mg/kg orally for 6 months; start after completing thymoglobulin.
Other Names:
Drug: Methylprednisolone
1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.
Other Names:
Drug: G-CSF
G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Tapan M. Kadia, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Tapan Mahendra Kadia, M.D./Assistant Professor, The University of Texas M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00806598 History of Changes |
| Other Study ID Numbers: | 2005-0115 |
| Study First Received: | December 9, 2008 |
| Last Updated: | August 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Myelodysplastic Syndrome Aplastic Anemia Thymoglobulin |
Cyclosporine Methylprednisolone G-CSF |
|
Anemia Anemia, Aplastic Myelodysplastic Syndromes Preleukemia Hematologic Diseases Bone Marrow Diseases Precancerous Conditions Neoplasms Antilymphocyte Serum Cyclosporine Cyclosporins Lenograstim Methylprednisolone acetate Prednisolone acetate Methylprednisolone |
Methylprednisolone Hemisuccinate Prednisolone Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Anti-Inflammatory Agents |