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| Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Institutes of Health (NIH) |
|---|---|
| Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00720629 |
Purpose
The purpose of this study is to test if a new drug named visilizumab is able to decrease the severity of graft-versus-host disease in patients treated with a mismatched donor. In this study we will use visilizumab in combination with tacrolimus and methotrexate that is the "study treatment".
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease |
Drug: Visilizumab Drug: Tacrolimus Drug: Methotrexate Drug: Antithymocyte globulin (ATG) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Visilizumab for the Prevention of Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation |
| Estimated Enrollment: | 75 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Study Treatment: Experimental
Visilizumab, Tacrolimus and Methotrexate
|
Drug: Visilizumab
3 mg/m3, IV (in the vein) on day 0, prior to hematopoietic cell infusion (transplant)
Drug: Tacrolimus
0.02 mg/kg/24h (based on ideal body weight) continuous infusion (over 24 hours) beginning on day 4 after transplant up to approximately day 180 after transplant. Switch to oral tacrolimus as able. Dose adjusted based on levels. In the absence of GVHD, the dose will be tapered beginning 100 days after transplant
Drug: Methotrexate
15 mg/m2 IV on Day 1 after transplant; 10 mg/m2 IV on Days 3, 6 and 11 after transplant
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Standard Treatment: Active Comparator
Antithymocyte-globulin (ATG), Tacrolimus and Methotrexate
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Drug: Antithymocyte globulin (ATG)
1 mg/kg IV over 6 hours on Day 3 before transplant; 3.25 mg/kg IV over 4 hours on days 2 and 1 before transplant.
Drug: Tacrolimus
0.03 mg/kg/24h (based on ideal body weight) continuous infusion (over 24 hours) beginning on day 3 before transplant up to approximately day 180 after transplant. Switch to oral tacrolimus as able. Dose adjusted based on levels. In the absence of GVHD, the dose will be tapered beginning 100 days after transplant.
Drug: Methotrexate
15 mg/m2 IV on Day 1 after transplant; 10 mg/m2 IV on Days 3, 6 and 11 after transplant
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This protocol is a two stage, controlled, phase II study, to assess safety and compare the grade of acute graft-versus-host disease (GVHD) with visilizumab or thymoglobulin (ATG) in combination with tacrolimus + methotrexate in patients at high risk of GVHD after transplant from unrelated donors mismatched for 1-2 alleles of any type at HLA A, B, C and DRB1.
The study design includes two stages. The first stage of the trial will enroll 15 patients on a single arm to be treated with "study treatment" (visilizumab, tacrolimus and methotrexate) to assess for treatment safety and exclude intolerable GVHD. The second stage of the trial includes a random control group of patients treated with the current "standard treatment" (ATG, tacrolimus, and methotrexate) or "study treatment". The purpose of this comparison is to determine if the "study treatment" visilizumab causes less severe side effects and if it is more potent in reducing graft-versus-host disease symptoms than the "standard treatment".
In addition, immunological studies will be conducted to test the pharmacokinetics, immunogenicity, and pharmacodynamics of visilizumab or ATG administered for GVHD prophylaxis after hematopoietic cell transplantation.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Cancer Center:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | Lia Perez, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Lia Perez, MD ) |
| Study ID Numbers: | MCC-15033, IRB 105645, R01-CA132197-06A2 |
| Study First Received: | July 21, 2008 |
| Last Updated: | December 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00720629 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
graft versus host disease GVHD allogeneic transplant GVHD prevention unrelated donors mismatched unrelated donors hematological malignancies |
Leukemia Lymphoma Myelodysplastic Syndrome Myelofibrosis Aplastic Anemia Multiple Myeloma |
|
Antimetabolites Immunologic Factors Aplastic Anemia Folate Tacrolimus Vitamin B9 Graft Versus Host Disease Leukemia Preleukemia Anemia, Aplastic Methotrexate Lymphoma Myelofibrosis |
Myelodysplastic Syndromes Anemia Folic Acid Antagonists Folinic Acid Immunosuppressive Agents Homologous Wasting Disease Multiple Myeloma Myeloid Metaplasia Antilymphocyte Serum Folic Acid Graft vs Host Disease Antirheumatic Agents Neoplasms, Plasma Cell |
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Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Tacrolimus Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Therapeutic Uses Abortifacient Agents Graft vs Host Disease Methotrexate Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
