Clinical trial · Interventional
Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation
Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or "mini" transplants. GVHD is a significant problem that may occur even after "mini" transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood stem cell transplantation | Procedure | — | UNRESOLVED |
| Bortezomib (Velcade) | Drug | Bortezomib | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib/Tacrolimus/Methotrexate post HSCT
- interventionNames
- Drug: Bortezomib (Velcade)
- Drug: Tacrolimus
- Drug: Methotrexate
- Procedure: blood stem cell transplantation
Primary outcomes (3)
- measure
- The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation
- timeFrame
- by day 45 post PBSC infusion
- description
- The MTD of bortezomib was evaluated at 3 dose levels: Dose level 1: 1.0 mg/m\^2 Dose level 2: 1.3 mg/m\^2 Dose level 3: 1.5 mg/m\^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur. If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If \>=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts then dose escalation will occur. If 4 evaluable pts in cohort, and 1 of the 4 experiences DLT then 1 additional pt treated at same dose level. If this additional pt experiences DLT then the previous dose will be declared to be the MTD. If additional pt does not experience DLT, then dose escalation will take place. If 5 evaluable pts in cohort, and 1 experiences DLT, then dose escalation will take place. If \>=2 of first 3, 4, or 5 pts experience DLT then the previous dose will be declared MTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies including myelodysplastic syndrome (MDS), who are at a high risk of complications after myeloablative transplantation * Patients have a donor (both related and unrelated) who are mismatched according to protocol criteria * 18 years of age or older * Performance status 0-2 * Life expectancy of \> 100 days * Female subject is either post-menopausal or sterilized or willing to use an acceptable form of birth control * Male subject agrees to use an acceptable form of birth control Exclusion Criteria: * Evidence of HIV infection * Total bilirubin \> 2.0mg/dl that is due to hepatocellular dysfunction * Aspartate aminotransferase (AST) \> 90 * Known active hepatitis B or C * Serum creatinine \> 2.0 * Greater than or equal to Grade 2 peripheral neuropathy within 21 days of enrollment * Prior allogeneic stem cell transplant * Patients with myeloproliferative disease (e.g. myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia) * Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Hypersensitivity to Velcade, boron or mannitol * Pregnant or breast feeding * Patient has received other investigational drugs 14 days before enrollment * Serious medical or psychiatric illness * Another active solid tumor malignancy at the time of study entry
References
Publications (1)
- DERIVEDKoreth J, Stevenson KE, Kim HT, Garcia M, Ho VT, Armand P, Cutler C, Ritz J, Antin JH, Soiffer RJ, Alyea EP 3rd. Bortezomib, tacrolimus, and methotrexate for prophylaxis of graft-versus-host disease after reduced-intensity conditioning allogeneic stem cell transplantation from HLA-mismatched unrelated donors. Blood. 2009 Oct 29;114(18):3956-9. doi: 10.1182/blood-2009-07-231092. Epub 2009 Aug 27. PMID 19713456