Phase 2
N=35
Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
Leukemia · Lymphoma · Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01323920 ↗Enrolled (actual)
35
Serious AEs
14.7%
Results posted
Mar 2014
Primary outcome: Primary: The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion — 32 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Tacrolimus (Drug); Methotrexate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion |
32 | — |
| SECONDARY The Percentage Donor Engraftment up to Day 30 Post Stem Cell Infusion |
94 | — |
| SECONDARY The Non-relapse Mortality, Progression-free and Overall Survival up to 1 Year After Stem Cell Infusion |
8.8; 85; 84 | — |
| SECONDARY The Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression up to 1 Year After Stem Cell Infusion |
53 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01323920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.