Clinical trial · Interventional
Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation
NCT04395222CI-TRIAL-00100167active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Transplant | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-thymocyte globulin (rabbit) | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Tocilizumab | Drug | — | UNRESOLVED |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- ATG Group I
- description
- Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, Day -3 and Day -1 of the transplant conditioning regimen. * Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) * Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. * Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. * Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
- interventionNames
- Drug: Tocilizumab
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Anti-thymocyte globulin (rabbit)
- Radiation: Total Body Irradiation
- type
- EXPERIMENTAL
- label
- ATG Group II
- description
- Anti-thymocyte Globulin (ATG) 1.5 mg/kg administered on Day -5, and Day -3 of the transplant conditioning regimen. * Fludarabine 30mg/m2 administered on Day -7 through Day -3 of transplant conditioning regimen (if under 60 years old), or on Day -5 through Day -3 of transplant conditioning regimen (if over 60 years old) * Melphalan 140 mg/m2 administered on Day -2 of transplant conditioning regimen. * Total Body Irradiation 2 Gray administered on Day -4, Day -3 of transplant conditioning regimen. * Tocilizumab 8 mg/kg administered on Day -1 of transplant conditioning regimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject must have a confirmed diagnosis of one of the following: 1. Relapsed or refractory acute leukemia (myeloid or lymphoid) 2. Acute leukemia in first remission at high-risk for recurrence 3. Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis 4. Myelodysplastic syndromes 5. Chronic myeloproliferative disease 6. Recurrent, refractory or high-risk malignant lymphoma 7. Chronic lymphocytic leukemia, relapsed or with poor prognostic features 8. Multiple myeloma 9. Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm) 2. Age ≥ 18 years. 3. Likely to benefit from allogeneic transplant in the opinion of the transplant physician. 4. An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame. 5. Karnofsky Performance Status (KPS) of ≥ 70%. 6. Acceptable organ function as defined below: 1. Serum bilirubin: \<2.0 mg/dL 2. ALT (SGPT) \<3x upper limit of normal (ULN) 3. Creatinine Clearance: \>50 mL/min/1.73m2 (eGFR as estimated by the modified MDRD equation) 4. Left ventricular ejection fraction \>40% 5. Pulmonary diffusion capacity \>40% predicted 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Life expectancy is severely limited by concomitant illness or uncontrolled infection. 2. Evidence of chronic active hepatitis or cirrhosis 3. Uncontrolled HIV disease. 4. Pregnancy or lactation. 5. History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal perforation 6. History of allergic reactions attributed to compounds of similar chemical or biological composition as tocilizumab, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
References
Publications (0)
Data not yet available
No reference posted for this study.