Clinical trial · Interventional
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Phase 3 Study of US-ATG-F to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients After Allogeneic Stem Cell Transplantation From Unrelated Donors
NCT01295710CI-TRIAL-00038030completedPhase 3Results 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 study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphoid Leukemia | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| GVHD | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Biological | — | UNRESOLVED |
| US-ATG-F | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- US-ATG-F
- description
- 20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
- interventionNames
- Biological: US-ATG-F
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Number of Participants With First Occurrence of Moderate to Severe Chronic GVHD According to 2005 NIH Criteria as Determined by the Independent Endpoint Committee or Death From Any Cause After Allogeneic Stem Cell Transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of one of the primary diseases in early or intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia, and myelodysplastic syndrome) * Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor * Patients with a Karnofsky Performance Score ≥ 70% Key Exclusion Criteria: * Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS) * Bacterial, viral, or fungal infections * Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have been tested positive for HIV * Patients with any concurrent malignancy. Cancer treated with curative intent \< 5 years previously will not be allowed except for patients with resected basal cell carcinoma or treated cervical carcinoma in situ * Known contraindications to the administration of rabbit immunoglobulin antibodies * Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products
References
Publications (1)
- DERIVEDChakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3. PMID 37341189