Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia (CyATG-FluATG)
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Purpose
The purpose of this study is to reduce the regimen related toxicities and transplantation related mortality after allogeneic stem cell transplantation in adult acquired aplastic anemia (AA), the trials of reduced dose of Cy along with fludarabine and ATG were performed.11-21 The investigators preliminary data of randomized comparison of cyclophosphamide plus fludarabine versus cyclophosphamide alone in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for bone marrow failure syndrome supports reduced dose of Cy along with fludarabine and ATG.
Conditioning regimen without Cy may reduce RRT because Cy-containing conditioning remains several RRT such as hemorrhagic cystitis, SOS and graft versus host disease (GvHD). Recently there were small trials of fludarabine and ATG (Flu-ATG) for the conditioning regimen of alloHSCT.22-24 These data raised the feasibility of fludarabine and ATG without Cy for patients with AA.
This new conditioning regimen of Flu-ATG will be compared to standard regimen of Cy- ATG in a randomized controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Aplastic Anemia |
Drug: Cy-ATG Drug: Flu-ATG |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
- regimen-related toxicities(RRT) [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- The RRTs will be evaluated in terms of mucositis, hemorrhagic cystitis, SOS, acute graft versus host disease (GvHD), infection rate, graft failure, time to engraftment.
- Overall feasibility will be evaluated by RRTs, time to engraftment, chronic GvHD, treatment-related mortality (TRM), relapse rate, infertility, chimerism status, changes of hemostatic variables, event-free survival and overall survival.
- Overall feasibility [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]Day 100 mortality rate, overall survival
| Estimated Enrollment: | 98 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CY-ATG(Arm1)
Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter. Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2 |
Drug: Cy-ATG
Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter. Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2 Other Names:
|
|
Experimental: Flu-ATG(Arm2)
Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 6 consecutive days (days -7 to -2) Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2
|
Drug: Flu-ATG
Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 6 consecutive days (days -7 to -2) Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Hawk Kim, M.D., Ph.D. | 82-52-250-8892 | kimhawkmd@gmail.com |
| Contact: Je-Hwan Lee, M.D., Ph.D. | jhlee3@amc.seoul.kr |
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Songpa-gu, Korea, Republic of, 138-736 | |
| Contact: Yae Eun Jang, Nurse 82-2-3010-6378 redpin75@paran.com | |
| Principal Investigator: | Hawk Kim, professor | Ulsan University Hospital, University of Ulsan College of Medicine |
More Information
Additional Information:
No publications provided by Cooperative Study Group A for Hematology
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yae Eun Jang, Research nurse, Cooperative Study Group A for Hematology |
| ClinicalTrials.gov Identifier: | NCT01145976 History of Changes |
| Other Study ID Numbers: | C-021 |
| Study First Received: | May 19, 2010 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Cooperative Study Group A for Hematology:
|
aplastic anemia, fludarabine, cyclophosphamide, thymoglobulin |
Additional relevant MeSH terms:
|
Anemia Anemia, Aplastic Hematologic Diseases Bone Marrow Diseases Antilymphocyte Serum Cyclophosphamide Fludarabine monophosphate Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013