Acute Myeloid LeukemiaPhase 2CBF(+)AMLNCT01146977
Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)
A Phase 2 study testing HDAC chemotherapy and Autologous HCT in people with Acute Myeloid Leukemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1). Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- HDAC chemotherapy and Autologous HCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2015
- Phase
- Phase 2
- 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
- Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFα2T1)], inv(16)(q13q22) (CBFβ/MYH11),t(16;16)(p13;q22) (CBFβ/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique.
- Patients who plan to receive the second cycle of HDAC consolidation chemotherapy.
- 15 years old or older and 65 years or younger
- Adequate performance status (Karnofsky score of 70 or more).
- Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
- Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
- Signed and dated informed consent must be obtained from patient.
Who cannot join
- Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736
Yae Eun Jang, nurse, 82-2-3010-6378, redpin75@paran.com
About this study
Official title: Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).
Read the detailed description
5.2 AUTOLOGOUS PBSCS HARVESTING
5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy.
5.2.2. For mobilization, recombinant human granulocyte- colony-stimulating factor (G-CSF, Filgrastim) will be given subcutaneously at a dose of 10 mcg/kg from day 9 of the 2nd HDAC cycle until the completion of harvesting.
5.2.3. PBSCs harvesting will be performed via perm-cath or Quinton catheter, which will be inserted with fluoroscopy-guided before starting and will be removed after finishing harvest.
5.2.4. Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 0.2 x 109/mm3. Peripheral blood mononuclear cells will be collected by leukapheresis method with 'CS-3000' (Baxter, Deerfield, IL) or other compatible machine. Cell collection will be performed for at least 2 days and the duration of collection can be extended until a target CD34+ cell dose of 5 x 106/kg (in terms of body weight of recipient) is collected.
5.2.5. If adequate numbers of CD34+ cells are not collected, the 3rd HDAC chemotherapy will be done and mobilization/harvest procedure will be repeated.
5.2.6. Stem cells harvested from patient will be frozen in liquid nitrogen tank for future autologous HCT cell infusion.
5.3.PRETRANSPLANT WORKUP FOR AUTOLOGOUS HCT 5.3.1. Pre-workup for checking the current disease status and feasibility for autologous HCT will be performed before the conditioning and infusion of autologous HCT.
5.3.2. It is recommended that baseline workup for hematologic / non-hematologic status will be performed at least 1 month prior to the initiation of conditioning. Bone marrow aspirate/ biopsy with cytogenetics and diagnostic lumbar puncture can be performed immediately before the initiation of conditioning.
5.3.3. Pretransplant workup tests are listed in Appendix IV.
5.4. CONDITIONING REGIMEN FOR AUTOLOGOUS HCT 5.4.1. On admission, 5.4.1.1.Menstruating women will be given norethindrone (Norlutate) 10mg po daily until platelet count is consistently over 100,000 /mcL.
5.4.1.2.Actual body weight (ABW) for busulfan will be calculated using following guidelines; 5.4.1.2.1.If ABW is less or equal to ideal body weight (IBW), use ABW. 5.4.1.2.2.If ABW is greater than IBW but ABW is within 120% of IBW, use IBW. 5.4.1.2.3.If ABW is 120% or greater than IBW, use IBW+25% (ABW-IBW). 5.4.1.2.4.IBW(ideal body weight) will be calculated in 5.4.1.2.4.1.Male: 50 kg + 2.3kg (height[inch]-60) 5.4.1.2.4.2.Female: 45.5kg + 2.3kg (height[inch]-60) 5.4.1.2.4.3.1inch=2.54cm 5.4.2. On day -8, preparation drugs will be administered to patient as below; 5.4.2.1.Hydration with 0.9% normal saline will be started at 6PM and infused continuously at a rate of 100mL/hr through day -4.
5.4.2.2.Allopurinol 300mg/day will be taken p.o. once a day from day-8 to -2. 5.4.2.3.Heparin 100 U/kg/day in normal saline 500 mL will be infused continuously at a rate of 20mL/hr through day 20 (6pm). Heparin should be discontinued if there is clinically significant bleeding or aPTT level exceeds 1.2 time of the upper normal limit.
5.4.2.4.Dilantin 15mg/kg (ABW) in normal saline 300cc will be infused continuously at a rate of 200mL/hr at 8PM, and then, 200mg will be taken p.o. twice a day through day -4. Dilantin level should be monitored in the morning of day-7 and -6 to maintain the level within 10 to 20 mg/L.
5.4.3. From day-7, conditioning drug will be administered to patient as below; 5.4.3.1.Busulfan 3.2mg/kg/day in normal saline of 10 times the volume of busulfan will be infused continuously over 3 hours with an interval of 24 hours on days -7 to -5 (for 3 days).
5.4.3.2.Etoposide 200mg/m2/day in normal saline 1000mL will be infused continuously over 5 hours twice a day with an interval of 12 hours on day-3 to -2 (for 2 days).
5.4.3.3.Antiemetics such as serotonin antagonist or lorazepam are allowed.
5.5. AUTOLOGOUS PBSCS INFUSION 5.5.1. Autologous PBSCs will be infused on day0. 5.5.1.1.Premedication including pheniramine maleate (avil) 45.5mg i.v., acetaminophen 600mg p.o., hydrocortisone 250mg i.v. and furosemide 20mg i.v. will be given 30 minutes before cell infusion.
5.5.1.2.PBSCs will be infused via saline infusion set without in-line filters. 5.5.1.3.Vital sign should be checked 4 times with 15 minutes of interval, 4 times with 30 minutes, and then 4 times with 1 hour. Electrocardiogram monitoring will be performed from the start until the completion of PBSCs infusion.
5.5.1.4.Following medications should not be administered simultaneously with PBSCs; 5.5.1.4.1.Lipid-containing total parenteral nutrition fluid 5.5.1.4.2.Conventional or liposomal amphotericin 5.6. SUPPORTIVE CARE 5.6.1. Recombinant human G-CSF (rhG-CSF) 450㎍ in 100 mL of D5W will be infused intravenously over 30 minutes from day 5 till ANC>3,000/㎕.
5.6.2. Ciprofloxacin 500mg will be given p.o. twice a day (for selective bowel decontamination) from day 1 till ANC>3,000/㎕. With the first fever spike, ciprofloxacin can be replaced with broad spectrum antibiotics.
5.6.3. Micafungin 50mg will be infused intravenously once a day from day1 till ANC>3,000/㎕.
5.6.4. Acyclovir 250mg/m2 will be infused twice a day from day1 till ANC>3,000/㎕.
5.6.5. In case of oral mucositis, sodium bicarbonate/saline mouthwash will be applied four times a day until resolved.
5.6.6. Clotrimazole or Canesten® powder can be applied to groin, axilla, and perianal area twice a day from day-8 until engraftment.
5.6.7. All cellular blood products must be transfused after leukocyte filtration and irradiation.
5.6.8. For woman of childbearing potential, adequate consultation for ovarian protection can be sought. For man who intend to have child(ren) in future, sperm banking can be recommended and performed.
5.7. EVALUATION DURING TREATMENT 5.7.1. CBC with differential count, ALT/AST, bilirubin with BUN/Cr, and electrolyte will be checked once daily.
5.7.2. Chemical battery with BUN/phosphorus, LDH and level of magnesium will be checked three times a week.
5.7.3. Coagulation battery with fibrinogen/d-dimer will be checked at day 0, 7, 14, 21 and once a week thereafter until discharge.
5.7.4. Protein C, antithrombin III, t-PA antigen, and PAI-1 antigen will be checked at day 0, 7, 14, and 21.
5.7.5. Urinalysis will be checked once a week. 5.7.6. Chest X-ray will be checked once a week routinely and more frequently according to patient's condition.
5.7.7. Blood galactomannan (aspergillosis antigen, GM) assay can be recommended to be checked once a week until ANC>3,000/ according to the physician's decision.
5.8. POST-HCT FOLLOW-UP INCLUDING MRD MONITORING 5.8.1. Patients will be followed with physical examination and appropriate blood test including CBC at least every 3 months for 3 years, every 6 months for the next 2 years, and then annually thereafter.
5.8.2. Toxicities related to treatment will be assessed and reported according to NCI CTCAE v3.0.
5.8.3. Minimal residual disease (MRD) monitoring with RQ-PCR for AML1/ETO or CBFβ/MYH11 will be performed before autologous HCT (bone marrow and peripheral blood, 1 month after autologous HCT (bone marrow and peripheral blood), and thereafter, every 3 months (peripheral blood only) until 3 years after autologous HCT.
5.8.4. If RQ-PCR is not available, RT-PCR and/or FISH can be used for MRD monitoring
- Conditions
- Acute Myeloid Leukemia
- Being tested
- HDAC chemotherapy, Autologous HCT
- Keywords
- CBF(+)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDAC chemotherapyOther
Also called Cytarabine 3g/m2
If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
Autologous HCTOther
After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.
If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.
| Study group | Role | What they receive |
|---|---|---|
| Autologous HCT | Experimental | 5.1.3. After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.
5.1.3.1. If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue. Receives: Other: Autologous HCT |
| HDAC chemotherapy | Active comparator | If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment. Receives: Other: HDAC chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIR, DFS
- Relapse incidence (cumulative incidence of relapse, CIR)
- Disease-free survival (DFS)
Measured: 6 years
Secondary outcomes (1)
TRM, EFS, OS
- Engraftment rate / time to engraftment
- Transplantation-related mortality (TRM)
- Event-free survival (EFS)
- Overall survival (OS)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2010 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Dae-Young Kim, professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146977
- Sponsor's protocol ID
- C-020
- Acronym
- CBF(+)AML
- Status last verified
- Jun 2010
- First submitted
- 19 May 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
- ClinicalTrials.gov ID
- NCT01146977
- Acronym / sponsor ID
- CBF(+)AML / C-020
- Conditions
- Acute Myeloid Leukemia
- Keywords
- CBF(+)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 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.
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).
Detailed description
5.2 AUTOLOGOUS PBSCS HARVESTING
5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy.
5.2.2. For mobilization, recombinant human granulocyte- colony-stimulating factor (G-CSF, Filgrastim) will be given subcutaneously at a dose of 10 mcg/kg from day 9 of the 2nd HDAC cycle until the completion of harvesting.
5.2.3. PBSCs harvesting will be performed via perm-cath or Quinton catheter, which will be inserted with fluoroscopy-guided before starting and will be removed after finishing harvest.
5.2.4. Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 0.2 x 109/mm3. Peripheral blood mononuclear cells will be collected by leukapheresis method with 'CS-3000' (Baxter, Deerfield, IL) or other compatible machine. Cell collection will be performed for at least 2 days and the duration of collection can be extended until a target CD34+ cell dose of 5 x 106/kg (in terms of body weight of recipient) is collected.
5.2.5. If adequate numbers of CD34+ cells are not collected, the 3rd HDAC chemotherapy will be done and mobilization/harvest procedure will be repeated.
5.2.6. Stem cells harvested from patient will be frozen in liquid nitrogen tank for future autologous HCT cell infusion.
5.3.PRETRANSPLANT WORKUP FOR AUTOLOGOUS HCT 5.3.1. Pre-workup for checking the current disease status and feasibility for autologous HCT will be performed before the conditioning and infusion of autologous HCT.
5.3.2. It is recommended that baseline workup for hematologic / non-hematologic status will be performed at least 1 month prior to the initiation of conditioning. Bone marrow aspirate/ biopsy with cytogenetics and diagnostic lumbar puncture can be performed immediately before the initiation of conditioning.
5.3.3. Pretransplant workup tests are listed in Appendix IV.
5.4. CONDITIONING REGIMEN FOR AUTOLOGOUS HCT 5.4.1. On admission, 5.4.1.1.Menstruating women will be given norethindrone (Norlutate) 10mg po daily until platelet count is consistently over 100,000 /mcL.
5.4.1.2.Actual body weight (ABW) for busulfan will be calculated using following guidelines; 5.4.1.2.1.If ABW is less or equal to ideal body weight (IBW), use ABW. 5.4.1.2.2.If ABW is greater than IBW but ABW is within 120% of IBW, use IBW. 5.4.1.2.3.If ABW is 120% or greater than IBW, use IBW+25% (ABW-IBW). 5.4.1.2.4.IBW(ideal body weight) will be calculated in 5.4.1.2.4.1.Male: 50 kg + 2.3kg (height[inch]-60) 5.4.1.2.4.2.Female: 45.5kg + 2.3kg (height[inch]-60) 5.4.1.2.4.3.1inch=2.54cm 5.4.2. On day -8, preparation drugs will be administered to patient as below; 5.4.2.1.Hydration with 0.9% normal saline will be started at 6PM and infused continuously at a rate of 100mL/hr through day -4.
5.4.2.2.Allopurinol 300mg/day will be taken p.o. once a day from day-8 to -2. 5.4.2.3.Heparin 100 U/kg/day in normal saline 500 mL will be infused continuously at a rate of 20mL/hr through day 20 (6pm). Heparin should be discontinued if there is clinically significant bleeding or aPTT level exceeds 1.2 time of the upper normal limit.
5.4.2.4.Dilantin 15mg/kg (ABW) in normal saline 300cc will be infused continuously at a rate of 200mL/hr at 8PM, and then, 200mg will be taken p.o. twice a day through day -4. Dilantin level should be monitored in the morning of day-7 and -6 to maintain the level within 10 to 20 mg/L.
5.4.3. From day-7, conditioning drug will be administered to patient as below; 5.4.3.1.Busulfan 3.2mg/kg/day in normal saline of 10 times the volume of busulfan will be infused continuously over 3 hours with an interval of 24 hours on days -7 to -5 (for 3 days).
5.4.3.2.Etoposide 200mg/m2/day in normal saline 1000mL will be infused continuously over 5 hours twice a day with an interval of 12 hours on day-3 to -2 (for 2 days).
5.4.3.3.Antiemetics such as serotonin antagonist or lorazepam are allowed.
5.5. AUTOLOGOUS PBSCS INFUSION 5.5.1. Autologous PBSCs will be infused on day0. 5.5.1.1.Premedication including pheniramine maleate (avil) 45.5mg i.v., acetaminophen 600mg p.o., hydrocortisone 250mg i.v. and furosemide 20mg i.v. will be given 30 minutes before cell infusion.
5.5.1.2.PBSCs will be infused via saline infusion set without in-line filters. 5.5.1.3.Vital sign should be checked 4 times with 15 minutes of interval, 4 times with 30 minutes, and then 4 times with 1 hour. Electrocardiogram monitoring will be performed from the start until the completion of PBSCs infusion.
5.5.1.4.Following medications should not be administered simultaneously with PBSCs; 5.5.1.4.1.Lipid-containing total parenteral nutrition fluid 5.5.1.4.2.Conventional or liposomal amphotericin 5.6. SUPPORTIVE CARE 5.6.1. Recombinant human G-CSF (rhG-CSF) 450㎍ in 100 mL of D5W will be infused intravenously over 30 minutes from day 5 till ANC>3,000/㎕.
5.6.2. Ciprofloxacin 500mg will be given p.o. twice a day (for selective bowel decontamination) from day 1 till ANC>3,000/㎕. With the first fever spike, ciprofloxacin can be replaced with broad spectrum antibiotics.
5.6.3. Micafungin 50mg will be infused intravenously once a day from day1 till ANC>3,000/㎕.
5.6.4. Acyclovir 250mg/m2 will be infused twice a day from day1 till ANC>3,000/㎕.
5.6.5. In case of oral mucositis, sodium bicarbonate/saline mouthwash will be applied four times a day until resolved.
5.6.6. Clotrimazole or Canesten® powder can be applied to groin, axilla, and perianal area twice a day from day-8 until engraftment.
5.6.7. All cellular blood products must be transfused after leukocyte filtration and irradiation.
5.6.8. For woman of childbearing potential, adequate consultation for ovarian protection can be sought. For man who intend to have child(ren) in future, sperm banking can be recommended and performed.
5.7. EVALUATION DURING TREATMENT 5.7.1. CBC with differential count, ALT/AST, bilirubin with BUN/Cr, and electrolyte will be checked once daily.
5.7.2. Chemical battery with BUN/phosphorus, LDH and level of magnesium will be checked three times a week.
5.7.3. Coagulation battery with fibrinogen/d-dimer will be checked at day 0, 7, 14, 21 and once a week thereafter until discharge.
5.7.4. Protein C, antithrombin III, t-PA antigen, and PAI-1 antigen will be checked at day 0, 7, 14, and 21.
5.7.5. Urinalysis will be checked once a week. 5.7.6. Chest X-ray will be checked once a week routinely and more frequently according to patient's condition.
5.7.7. Blood galactomannan (aspergillosis antigen, GM) assay can be recommended to be checked once a week until ANC>3,000/ according to the physician's decision.
5.8. POST-HCT FOLLOW-UP INCLUDING MRD MONITORING 5.8.1. Patients will be followed with physical examination and appropriate blood test including CBC at least every 3 months for 3 years, every 6 months for the next 2 years, and then annually thereafter.
5.8.2. Toxicities related to treatment will be assessed and reported according to NCI CTCAE v3.0.
5.8.3. Minimal residual disease (MRD) monitoring with RQ-PCR for AML1/ETO or CBFβ/MYH11 will be performed before autologous HCT (bone marrow and peripheral blood, 1 month after autologous HCT (bone marrow and peripheral blood), and thereafter, every 3 months (peripheral blood only) until 3 years after autologous HCT.
5.8.4. If RQ-PCR is not available, RT-PCR and/or FISH can be used for MRD monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous HCT | Experimental | Other: Autologous HCT5.1.3. After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information. 5.1.3.1. If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue. |
| HDAC chemotherapy | Active comparator | Other: HDAC chemotherapyIf he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFα2T1)], inv(16)(q13q22) (CBFβ/MYH11),t(16;16)(p13;q22) (CBFβ/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique.
- Patients who plan to receive the second cycle of HDAC consolidation chemotherapy.
- 15 years old or older and 65 years or younger
- Adequate performance status (Karnofsky score of 70 or more).
- Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
Key exclusion criteria (6 listed)
- Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
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 |
|---|---|---|
| HDAC chemotherapyAlso: Cytarabine 3g/m2If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment. | Other | HDAC chemotherapy |
| Autologous HCTAfter achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information. If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue. | Other | Autologous HCT |
Primary outcome
CIR, DFS
Time frame: 6 years
* Relapse incidence (cumulative incidence of relapse, CIR) * Disease-free survival (DFS)
1 secondary outcome
TRM, EFS, OS
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Autologous hematopoietic cell transplantation for core-binding factor positive acute myeloid leukemia in the first complete remissionLink 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.
Dae-Young Kim, professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDAC chemotherapy and Autologous HCT in people with Acute Myeloid Leukemia, 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 7 inclusion and 6 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 22 Jun 2010. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dae-Young Kim, professor (82-2-3010-5930, dani@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIR, DFS (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2010.