Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01145976
• Date of registration: 19/05/2010
• Prospective Registration: No
• Primary sponsor: Cooperative Study Group A for Hematology
• Public title: Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia CyATG-FluATG
• Scientific title: Randomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic Anemia
• Date of first enrolment: March 2010
• Target sample size: 98
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01145976
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: Hawk Kim, M.D., Ph.D.

• Name: Yae Eun Jang, Nurse

• Name: Hawk Kim, professor
• Affiliation: Ulsan University Hospital, University of Ulsan College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Severe aplastic anemia

- Severe aplastic anemia (SAA) is defined as a hypocellular bone marrow
(cellularity<25%) and two or more of the following: granulocyte count <500/ml,
platelet count <20,000/ml, and corrected reticulocyte count <1.0%

- Very severe aplastic anemia (VSAA) is defined as the criteria for SAA plus a
granulocyte count <200/ml

- Patients should be 15 years of age or older, but younger than 65 years.

- The performance status of the patients should be 70 or over by Karnofsky performance
scale (see Appendix I).

- Patients must have adequate hepatic function (bilirubin less than 2 mg/dl, AST and
ALT less than three times the upper normal limit)

- Patients must have adequate renal function (creatinine less than 2.0 mg/dl).

- Patients must have adequate cardiac function (ejection fraction > 45% on
echocardiogram).

Exclusion criteria:

- Patients should not have major illness or organ failure.

- Patients must not have a psychiatric disorder or mental deficiency severe as to make
compliance with the treatment unlikely, and making informed consent impossible.

- Patients must not be in pregnancy.

- Hypoplastic myelodysplastic syndrome

- Paroxysmal nocturnal hemoglobinuria



Age minimum: 15 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Aplastic Anemia

Intervention(s)

Drug: Flu-ATG

Drug: Cy-ATG

Primary Outcome(s)

regimen-related toxicities(RRT) [Time Frame: 7 years]

Secondary Outcome(s)

Overall feasibility [Time Frame: 7 years]

Secondary ID(s)

C-021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors