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

Neovii Biotech

Status and phase: Completed; Phase 3

Conditions: Adult Acute Lymphoid Leukemia; Adult Acute Myeloid Leukemia; GVHD; Myelodysplastic Syndrome

Treatments: Biological: US-ATG-F; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295710

IV-ATG-SCT-01

Details and patient eligibility

About

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.

Full description

This study is randomized, prospective, double-blind, placebo-controlled, phase 3 study evaluating the prevention of moderate to severe chronic GVHD in patients undergoing bone marrow or peripheral blood stem cell transplantation from matched, unrelated donors for acute leukemia and myelodysplastic syndrome during the first year after transplant.

Patients meeting all the inclusion and none of the exclusion criteria will be randomized (1:1). All patients will receive premedication and study drug 3 days prior to transplantation.

Enrollment: 260 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

US-ATG-F

Active Comparator group

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

Treatment:

Biological: US-ATG-F

Placebo

Placebo Comparator group

Description:

250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

Treatment:

Biological: Placebo