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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) 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Thymoglobulin + Cyclosporin: Experimental
Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF
|
Drug: Thymoglobulin
3.5 or 2.5 mg/kg/day IV for 5 days
5 mg/kg orally for 6 months; start after completing thymoglobulin.
Drug: Methylprednisolone
1 mg/kg/day IV for 4 days, given before each dose of thymoglobulin.
Drug: G-CSF
G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.
|
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| Contact: Tapan M Kadia, M.D. | 713/563-3534 | tkadia@mdanderson.org |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Tapan M. Kadia, M.D. 713-563-3534 tkadia@mdanderson.org | |
| Principal Investigator: Tapan M. Kadia, M.D. | |
| Principal Investigator: | Tapan M. Kadia, M.D. | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Tapan Mahendra Kadia, M.D./Assistant Professor ) |
| Study ID Numbers: | 2005-0115 |
| Study First Received: | December 9, 2008 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00806598 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Myelodysplastic Syndrome Aplastic Anemia Thymoglobulin |
Cyclosporine Methylprednisolone G-CSF |
|
Anti-Inflammatory Agents Anti-Infective Agents Cyclosporine Precancerous Conditions Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Cyclosporins |
Preleukemia Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Anemia, Aplastic Dermatologic Agents Methylprednisolone Hemisuccinate Disease Antineoplastic Agents, Hormonal Hematologic Diseases Myelodysplastic Syndromes Gastrointestinal Agents Anemia Methylprednisolone acetate |