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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01295710




Registration number
NCT01295710
Ethics application status
Date submitted
9/02/2011
Date registered
14/02/2011
Date last updated
9/04/2019

Titles & IDs
Public title
Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)
Scientific 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
Secondary ID [1] 0 0
IV-ATG-SCT-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
GVHD 0 0
Adult Acute Myeloid Leukemia 0 0
Adult Acute Lymphoid Leukemia 0 0
Myelodysplastic Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - US-ATG-F
Treatment: Other - Placebo

Active comparator: US-ATG-F - 20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation

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


Treatment: Other: US-ATG-F
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: Other: Placebo
250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Time from first study drug administration until the 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, assessed up to 48 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Time from first study drug administration until the occurrence of death from any cause, assessed up to 48 months
Secondary outcome [2] 0 0
Number of Participants With Chronic GVHD Mild to Severe
Timepoint [2] 0 0
Time from first study drug administration until the first occurrence of mild to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [3] 0 0
Number of Participants With Chronic GVHD Moderate to Severe
Timepoint [3] 0 0
Time from first study drug administration until the first occurrence of moderate to severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [4] 0 0
Number of Participants With Chronic GVHD Severe
Timepoint [4] 0 0
Time from first study drug administration until the first occurrence of severe chronic GVHD according to 2005 NIH criteria as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [5] 0 0
Number of Participants With Acute GVHD Grade I-IV
Timepoint [5] 0 0
Time from first study drug administration until the first occurrence of acute GVHD grade I-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [6] 0 0
Number of Participants With Acute GVHD Grade II-IV
Timepoint [6] 0 0
Time from first study drug administration until the first occurrence of acute GVHD grade II-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [7] 0 0
Number of Participants With Acute GVHD Grade III-IV
Timepoint [7] 0 0
Time from first study drug administration until the first occurrence of acute GVHD grade III-IV as determined by the Investigators, with death and re transplantation as competing risks, assessed up to 48 months
Secondary outcome [8] 0 0
Number of Participants With Relapse
Timepoint [8] 0 0
Time from first study drug administration until the occurrence of relapse, with death as competing risk, assessed up to 48 months
Secondary outcome [9] 0 0
Disease-free Survival
Timepoint [9] 0 0
Time from first study drug administration until the occurrence of relapse or death, assessed up to 48 months
Secondary outcome [10] 0 0
Number of Participants With Transplant Related Mortality
Timepoint [10] 0 0
Time from first study drug administration until the occurrence of transplant related mortality, assessed up to 48 months
Secondary outcome [11] 0 0
Systemic Immunosuppressive Medication for Treatment of Moderate to Severe Chronic GVHD
Timepoint [11] 0 0
Time from first study drug administration until start of systemic immunosuppressive medicine for treatment of moderate to severe chronic GVHD as determined by the Investigator, with death and re-transplantation as competing risks, assessed up to 48 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2015
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
03050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neovii Biotech
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01295710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Kuan
Address 0 0
Neovii Biotech
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01295710