NCT01295710

Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT01295710

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

GVHD

Adult Acute Myeloid Leukemia

Adult Acute Lymphoid Leukemia

Myelodysplastic Syndrome

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: BIOLOGICAL
- Name: 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
- Arm Group Labels: US-ATG-F
- Type: BIOLOGICAL
- Name: Placebo
- Description: 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
- Arm Group Labels: Placebo

Sponsor

Neovii Biotech