Aplastic AnemiaPhase 3CyATG-FluATGNCT01145976
Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia
A Phase 3 study testing Cy-ATG and Flu-ATG in people with Aplastic Anemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- Cy-ATG and Flu-ATG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Je-Hwan Lee, M.D., Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 138-736
Yae Eun Jang, Nurse, 82-2-3010-6378, redpin75@paran.com
About this study
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
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.
Read the detailed description
TREATMENT PLAN
- The patients will be admitted to laminar air flow room.
- The patients will have triple lumen Hickman central venous catheter (CVC) placed. Chest X-ray should be taken after CVC placement to confirm the location of CVC and absence of pneumothorax.
- Menstruating women will be given norethindrone (Primolut) 10 mg po daily.
- The preparatory regimen is as follows: Conditioning therapy will start on day -5 in patients who are randomized to receive 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. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. 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. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight. Conditioning therapy will start on day -7 in patients who are randomized to receive 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. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.
- GVHD prophylaxis will include cyclosporine plus methotrexate. The patients will receive cyclosporine 1.5 mg/kg in NS 100 ml i.v. over 2-4 hours q 12 hrs (dose of cyclosporine rounded to nearest 5 mg) starting day -1 at 6 a.m. Cyclosporine dose will be adjusted to provide appropriate level and according to the change of renal function (see Appendix II). Cyclosporine dosing will be changed to oral dosing when oral feeding became feasible at the twice the i.v. dosages. In addition, the patients will receive methotrexate 15 mg/m2 i.v. push on day 1 and 10 mg/m2 on days 3, 6, and 11. The dose of methotrexate will be decreased or omitted according to the guideline provided in Appendix III. The dose of cyclosporine will be decreased by 10 % every month starting day 60 of BMT provided that there is no clinical evidence of GVHD.
- Hematopoietic stem cell collection from the donors.
Mobilized peripheral blood stem cells are used but bone marrow collection in case of sibling donor is permitted.
Bone marrow collection
- Packed red cell 2 units will be collected from donor for autologous transfusion before hematopoietic stem cells collection.
- Hematopoietic stem cells are collected from bone marrow under an appropriate anesthesia.
- After collection, Feroba 1T bid will be given to the donor for 1 month.
Mobilized peripheral blood stem cell collection
- Recombinant human granulocyte colony-stimulating factor (G-CSF) 10 mcg/kg will be administered sc to stem cell donors daily for 4 days (from day -3 to day 0).
- Daily CBC will be done.
- Starting day 4 of G-CSF administration (day 0), peripheral blood mononuclear cells will be collected by leukapheresis CS3000 for 2 days (days 0 and 1). A sample will be taken for cell count of total cell, mononuclear cells, CD34+ cell, CD3+ cell, CD4+ cells, and CD8+ cells.
- After the sampling, the final product will be infused to the patients immediately on day 0 and day1.
- At least 2x10^6/kg of CD34+ cells should be collected on day 0. If not, additional collection may be scheduled under the discretion of attending physician. 4.Hematopoietic stem cell infusion
- For ABO matched or minor mismatched transplantation, premedication with Avil 45.5 mg i.v. push and tylenol 600 mg p.o. will be given. Stem cell will be infused via CVC over 1 hr.
- For major ABO mismatched transplantation, premedication with Avil 45.5 mg i.v. push, tylenol 600 mg p.o., 10 % mannitol 100 g i.v. over 4 hrs will be started 30 min before stem cell infusion, and hydrocortisone 250 mg i.v. will be given immediately before and 30 min of stem cell infusion. Stem cells will be infused via CVC over 1 hour.
- Conditions
- Aplastic Anemia
- Being tested
- Cy-ATG, Flu-ATG
- Keywords
- aplastic anemia, fludarabine, cyclophosphamide, thymoglobulin
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cy-ATGDrug
Also called Cyclophosphamide, Thymoglobulin
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
Flu-ATGDrug
Also called Fludarabine, Thymoglobulin
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
| Study group | Role | What they receive |
|---|---|---|
| CY-ATG(Arm1) | Active comparator | 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 Receives: Drug: Cy-ATG |
| Flu-ATG(Arm2) | Experimental | 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 Receives: Drug: Flu-ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
regimen-related toxicities(RRT)
- 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.
Measured: 7 years
Secondary outcomes (1)
Overall feasibility
Day 100 mortality rate, overall survival
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Yae Eun Jang, Cooperative Study Group A for Hematology
- Investigators
- Hawk Kim, professor, Principal investigator, Ulsan University Hospital, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145976
- Sponsor's protocol ID
- C-021
- Acronym
- CyATG-FluATG
- Status last verified
- Sep 2012
- First submitted
- 19 May 2010
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim H, Lee JH, Joo YD, Bae SH, Hyun MS, Lee JH, Kim DY, Lee WS, Ryoo HM, Kim MK, Park JH, Lee KH; Cooperative Study Group A for Hematology (COSAH). A randomized comparison of cyclophosphamide vs. reduced dose cyclophosphamide plus fludarabine for allogeneic hematopoietic cell transplantation in patients with aplastic anemia and hypoplastic myelodysplastic syndrome. Ann Hematol. 2012 Sep;91(9):1459-69. doi: 10.1007/s00277-012-1462-x. Epub 2012 Apr 18.
PubMed 22526363
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01145976
- Acronym / sponsor ID
- CyATG-FluATG / C-021
- Conditions
- Aplastic Anemia
- Keywords
- aplastic anemia, fludarabine, cyclophosphamide, thymoglobulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Mar 2010
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TREATMENT PLAN
- The patients will be admitted to laminar air flow room.
- The patients will have triple lumen Hickman central venous catheter (CVC) placed. Chest X-ray should be taken after CVC placement to confirm the location of CVC and absence of pneumothorax.
- Menstruating women will be given norethindrone (Primolut) 10 mg po daily.
- The preparatory regimen is as follows: Conditioning therapy will start on day -5 in patients who are randomized to receive 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. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. 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. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight. Conditioning therapy will start on day -7 in patients who are randomized to receive 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. Premedication for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.
- GVHD prophylaxis will include cyclosporine plus methotrexate. The patients will receive cyclosporine 1.5 mg/kg in NS 100 ml i.v. over 2-4 hours q 12 hrs (dose of cyclosporine rounded to nearest 5 mg) starting day -1 at 6 a.m. Cyclosporine dose will be adjusted to provide appropriate level and according to the change of renal function (see Appendix II). Cyclosporine dosing will be changed to oral dosing when oral feeding became feasible at the twice the i.v. dosages. In addition, the patients will receive methotrexate 15 mg/m2 i.v. push on day 1 and 10 mg/m2 on days 3, 6, and 11. The dose of methotrexate will be decreased or omitted according to the guideline provided in Appendix III. The dose of cyclosporine will be decreased by 10 % every month starting day 60 of BMT provided that there is no clinical evidence of GVHD.
- Hematopoietic stem cell collection from the donors.
Mobilized peripheral blood stem cells are used but bone marrow collection in case of sibling donor is permitted.
Bone marrow collection
- Packed red cell 2 units will be collected from donor for autologous transfusion before hematopoietic stem cells collection.
- Hematopoietic stem cells are collected from bone marrow under an appropriate anesthesia.
- After collection, Feroba 1T bid will be given to the donor for 1 month.
Mobilized peripheral blood stem cell collection
- Recombinant human granulocyte colony-stimulating factor (G-CSF) 10 mcg/kg will be administered sc to stem cell donors daily for 4 days (from day -3 to day 0).
- Daily CBC will be done.
- Starting day 4 of G-CSF administration (day 0), peripheral blood mononuclear cells will be collected by leukapheresis CS3000 for 2 days (days 0 and 1). A sample will be taken for cell count of total cell, mononuclear cells, CD34+ cell, CD3+ cell, CD4+ cells, and CD8+ cells.
- After the sampling, the final product will be infused to the patients immediately on day 0 and day1.
- At least 2x10^6/kg of CD34+ cells should be collected on day 0. If not, additional collection may be scheduled under the discretion of attending physician. 4.Hematopoietic stem cell infusion
- For ABO matched or minor mismatched transplantation, premedication with Avil 45.5 mg i.v. push and tylenol 600 mg p.o. will be given. Stem cell will be infused via CVC over 1 hr.
- For major ABO mismatched transplantation, premedication with Avil 45.5 mg i.v. push, tylenol 600 mg p.o., 10 % mannitol 100 g i.v. over 4 hrs will be started 30 min before stem cell infusion, and hydrocortisone 250 mg i.v. will be given immediately before and 30 min of stem cell infusion. Stem cells will be infused via CVC over 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CY-ATG(Arm1) | Active comparator | Drug: Cy-ATGHydration 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 |
| Flu-ATG(Arm2) | Experimental | Drug: Flu-ATGFludarabine 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 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cy-ATGAlso: Cyclophosphamide, ThymoglobulinHydration 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(Arm1) |
| Flu-ATGAlso: Fludarabine, ThymoglobulinFludarabine 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(Arm2) |
Primary outcome
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.
1 secondary outcome
Overall feasibility
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- Derived from this study: PubMed 22526363Kim H, Lee JH, Joo YD, Bae SH, Hyun MS, Lee JH, Kim DY, Lee WS, Ryoo HM, Kim MK, Park JH, Lee KH; Cooperative Study Group A for Hematology (COSAH). A randomized comparison of cyclophosphamide vs. reduced dose cyclophosphamide plus fludarabine for allogeneic hematopoietic cell transplantation in patients with aplastic anemia and hypoplastic myelodysplastic syndrome. Ann Hematol. 2012 Sep;91(9):1459-69. doi: 10.1007/s00277-012-1462-x. Epub 2012 Apr 18.
- Randomized comparison of cyclophosphamide versus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for bone marrow failure syndromeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Je-Hwan Lee, M.D., Ph.D. contact
Hawk Kim, professor principal investigator
Ulsan University Hospital, University of Ulsan College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cy-ATG and Flu-ATG in people with Aplastic Anemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hawk Kim, M.D., Ph.D. (82-52-250-8892, kimhawkmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regimen-related toxicities(RRT) (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.