Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
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Purpose
A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD.
In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndrome |
Drug: Bortezomib, Tacrolimus, Methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study |
- To determine the incidence of grade II-IV acute GVHD by day 100 after stem cell infusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To assess percentage donor engraftment by day 30 post stem cell infusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]To assess percentage donor engraftment by day 30 post stem cell infusion, defined as the first of 3 consecutive days tested of documented absolute netrophil count (ANC) >/= 500 cells/u/L
- To assess non-relapse mortality, progression-free and overall survival by 1 year after stem cell infusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine the incidence of chronic GVHD requiring systemic immune suppression by 1 year after stem cell infusion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Velcade/Tac/MTX
Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV |
Drug: Bortezomib, Tacrolimus, Methotrexate
Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV
Other Name: Velcade
|
Detailed Description:
Before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood cells taken from your sibling or unrelated donor.
You will receive 3 drugs for your GVHD prophylaxis:
Tacrolimus will be started 3 days before your transplant. It will be given intravenously and later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.
Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.
Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies
- HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor
- ECOG performance status 0-2
- Adequate organ function
- Able to understand and willing to sign a written informed consent document
- Agrees to practice adequate contraception per study requirements
Exclusion Criteria:
- Pregnant or breastfeeding
- Recipient of prior allogeneic or autologous stem cell transplantation
- Prior abdominal radiation therapy
- HIV-positive on combination antiretroviral therapy
- Seropositive for hepatitis B or C
- Allergies to bortezomib, boron, or mannitol
- Myocardial infarction within last 6 months, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias
- Uncontrolled bacterial, viral or fungal infections
- Seizures or history of seizures
- History of another non-hematologic malignancy unless disease-free for at least 5 years
- Uncontrolled intercurrent illness
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | John Koreth, MBBS, DPhil | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | John Koreth, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01323920 History of Changes |
| Other Study ID Numbers: | 11-007 |
| Study First Received: | March 24, 2011 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Stem Cell Transplant Allogeneic Transplant Donors |
Additional relevant MeSH terms:
|
Graft vs Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Methotrexate |
Bortezomib Tacrolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013