Phase 3
Completed N=254
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
GVHD · leukemia · Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT01295710 ↗
Enrolled (actual)
254
Serious AEs
74.0%
Results posted
Mar 2019
Primary outcomePrimary: 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 — 60; 72 Participants
◆ Published Evidence
Established
24citations · ~8 / year
Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults.
Summary
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.
Linked Publications
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Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
60; 72 | — |
| SECONDARY Overall Survival |
49; 36 | — |
| SECONDARY Number of Participants With Chronic GVHD Mild to Severe |
18; 50 | — |
| SECONDARY Number of Participants With Chronic GVHD Moderate to Severe |
13; 45 | — |
| SECONDARY Number of Participants With Chronic GVHD Severe |
3; 16 | — |
| SECONDARY Number of Participants With Acute GVHD Grade I-IV |
48; 71 | — |
| SECONDARY Number of Participants With Acute GVHD Grade II-IV |
28; 53 | — |
| SECONDARY Number of Participants With Acute GVHD Grade III-IV |
8; 17 | — |
| SECONDARY Number of Participants With Relapse |
37; 26 | — |
| SECONDARY Disease-free Survival |
61; 49 | — |
| SECONDARY Number of Participants With Transplant Related Mortality |
24; 23 | — |
| SECONDARY Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD |
8; 33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01295710) and the linked publication. 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. Informational only — not medical advice.