Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia (CyATG-FluATG)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01145976 |
|
Recruitment Status : Unknown
Verified September 2012 by Yae Eun Jang, Cooperative Study Group A for Hematology.
Recruitment status was: Recruiting
First Posted : June 17, 2010
Last Update Posted : September 7, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Aplastic Anemia | Drug: Cy-ATG Drug: Flu-ATG | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 98 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2010 |
| Estimated Primary Completion Date : | February 2015 |
| Estimated Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
|
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:
|
- regimen-related toxicities(RRT) [ Time Frame: 7 years ]
- 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 ]Day 100 mortality rate, overall survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145976
| 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 |
Additional Information:
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 |
| First Posted: | June 17, 2010 Key Record Dates |
| Last Update Posted: | September 7, 2012 |
| Last Verified: | September 2012 |
Keywords provided by Yae Eun Jang, Cooperative Study Group A for Hematology:
|
aplastic anemia, fludarabine, cyclophosphamide, thymoglobulin |
Additional relevant MeSH terms:
|
Anemia Anemia, Aplastic Hematologic Diseases Bone Marrow Diseases Cyclophosphamide Fludarabine phosphate Thymoglobulin Antilymphocyte Serum Fludarabine Vidarabine Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |