Clinical trial · Interventional
In-Vivo Activated T-Cell Depletion to Prevent GVHD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Treatment ineffective
Summary
Brief summary (as posted)
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease. This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mantle-Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basiliximab | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Patients With Acute Grade II-IV GVHD
- timeFrame
- until 30 days after stem cell transplant
- description
- Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
Secondary outcomes (4)
- measure
- Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).
- timeFrame
- until 30 days after stem cell transplant
- measure
- Number of Days for Absolute Neutrophil Count to Recover
- timeFrame
- From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)
- description
- Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol * Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis. Exclusion Criteria: * Active CNS disease (the presence of leukemic blasts in the CSF) * Pregnancy or breast-feeding * SGOT \>3x upper limit of normal * Creatinine \>2 or creatinine clearance \<50cc/hr. * Fractional shortening by echocardiogram not within normal limits per institution * Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia * Prior allogeneic transplant
References
Publications (0)
Data not yet available