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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Heart, Lung, and Blood Institute (NHLBI) National Cancer Institute (NCI) National Institutes of Health (NIH) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00474149 |
Primary Objective:
The primary objective is to estimate the proportion of CR at Day 28 of therapy for newly diagnosed acute graft-versus-host disease (GVHD) for each of these agents given in combination with corticosteroids.
Secondary Objectives:
The secondary objectives are to determine: proportion of partial response (PR), mixed response and progression at Day 28; proportion of treatment failure (no response, progression, or mortality) by Day 14; the incidence of GVHD flares requiring increased therapy before Day 90.
In addition, the following endpoints will be examined: incidence of discontinuation of immune suppression without flare by Days 90, 180 and 270 post-therapy, incidence of chronic GVHD by 9 months, overall survival at 6 and 9 months post initiation of therapy, incidence of systemic infections within 3 months of initiation of therapy, incidence of Epstein-Barr virus (EBV)- associated lymphoma.
Condition | Intervention | Phase |
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Graft-Versus-Host Disease |
Drug: Etanercept Drug: Mycophenolate Mofetil Drug: Denileukin Diftitox Drug: Pentostatin Drug: Prednisone Drug: Methylprednisolone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Initial Systemic Treatment of Acute GVHD: A Phase II Randomized Trial Evaluating Etanercept, Mycophenolate Mofetil (MMF), Denileukin Diftitox (Ontak), and Pentostatin in Combination With Corticosteroids |
Estimated Enrollment: | 180 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Etanercept + Corticosteroids
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Drug: Etanercept
25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in CR by 4 weeks.
Drug: Prednisone
2.4 mg/kg PO daily
Drug: Methylprednisolone
2.0 mg/kg IV divided 2-3 times daily
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2: Active Comparator
Mycophenolate Mofetil + Corticosteroids
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Drug: Mycophenolate Mofetil
20 mg/kg PO (by mouth) or IV BID; continue through prednisone taper, then taper MMF over 4 weeks.
Drug: Prednisone
2.4 mg/kg PO daily
Drug: Methylprednisolone
2.0 mg/kg IV divided 2-3 times daily
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3: Active Comparator
Denileukin Diftitox + Corticosteroids
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Drug: Denileukin Diftitox
9 mcg/kg IV on Days 1, 3, 5, 15, 17, 19.
Drug: Prednisone
2.4 mg/kg PO daily
Drug: Methylprednisolone
2.0 mg/kg IV divided 2-3 times daily
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4: Active Comparator
Pentostatin + Corticosteroids
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Drug: Pentostatin
1.5 mg/m^2 daily for 3 days; Days 1-3 and repeat Days 15-17.
Drug: Prednisone
2.4 mg/kg PO daily
Drug: Methylprednisolone
2.0 mg/kg IV divided 2-3 times daily
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Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Amin Alousi, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Amin Alousi, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0167 |
Study First Received: | May 14, 2007 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00474149 |
Health Authority: | United States: Food and Drug Administration |
Graft-Versus-Host Disease Stem Cell Transplant Corticosteroids Etanercept Mycophenolate Mofetil MMF Denileukin Diftitox Ontak |
Pentostatin Prednisone Medrol Nipent, Deoxycoformycin DCF MMF CellCept® ENBRELTM |
Prednisone Pentostatin Graft versus host disease Methylprednisolone Mycophenolic Acid Methylprednisolone acetate Prednisolone acetate TNFR-Fc fusion protein |
Homologous wasting disease Interleukin-2 Denileukin diftitox Prednisolone Mycophenolate mofetil Graft vs Host Disease Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Neuroprotective Agents Hormones Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Immune System Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Protective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |