Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01146977
Status:
UNKNOWN
Last Update Posted:
2010-06-22
First Post:
2010-05-19
Brief Title:
Autologous Hematopoietic Cell Transplantation for Core-binding Factor CBF Acute Myeloid Leukemia AML in the First Complete Remission CR1
Sponsor:
Cooperative Study Group A for Hematology
Organization:
Cooperative Study Group A for Hematology
Study Overview
Official Title:
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBFAML
Brief 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
Detailed Description:
52 AUTOLOGOUS PBSCS HARVESTING
521 PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy
522 For mobilization recombinant human granulocyte- colony-stimulating factor G-CSF Filgrastim will be given subcutaneously at a dose of 10 mcgkg from day 9 of the 2nd HDAC cycle until the completion of harvesting
523 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
524 Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 02 x 109mm3 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 106kg in terms of body weight of recipient is collected
525 If adequate numbers of CD34 cells are not collected the 3rd HDAC chemotherapy will be done and mobilizationharvest procedure will be repeated
526 Stem cells harvested from patient will be frozen in liquid nitrogen tank for future autologous HCT cell infusion
53PRETRANSPLANT WORKUP FOR AUTOLOGOUS HCT 531 Pre-workup for checking the current disease status and feasibility for autologous HCT will be performed before the conditioning and infusion of autologous HCT
532 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
533 Pretransplant workup tests are listed in Appendix IV
54 CONDITIONING REGIMEN FOR AUTOLOGOUS HCT 541 On admission 5411Menstruating women will be given norethindrone Norlutate 10mg po daily until platelet count is consistently over 100000 mcL
5412Actual body weight ABW for busulfan will be calculated using following guidelines 54121If ABW is less or equal to ideal body weight IBW use ABW 54122If ABW is greater than IBW but ABW is within 120 of IBW use IBW 54123If ABW is 120 or greater than IBW use IBW25 ABW-IBW 54124IBWideal body weight will be calculated in 541241Male 50 kg 23kg heightinch-60 541242Female 455kg 23kg heightinch-60 5412431inch254cm 542 On day -8 preparation drugs will be administered to patient as below 5421Hydration with 09 normal saline will be started at 6PM and infused continuously at a rate of 100mLhr through day -4
5422Allopurinol 300mgday will be taken po once a day from day-8 to -2 5423Heparin 100 Ukgday in normal saline 500 mL will be infused continuously at a rate of 20mLhr through day 20 6pm Heparin should be discontinued if there is clinically significant bleeding or aPTT level exceeds 12 time of the upper normal limit
5424Dilantin 15mgkg ABW in normal saline 300cc will be infused continuously at a rate of 200mLhr at 8PM and then 200mg will be taken po 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 mgL
543 From day-7 conditioning drug will be administered to patient as below 5431Busulfan 32mgkgday 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
5432Etoposide 200mgm2day 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
5433Antiemetics such as serotonin antagonist or lorazepam are allowed
55 AUTOLOGOUS PBSCS INFUSION 551 Autologous PBSCs will be infused on day0 5511Premedication including pheniramine maleate avil 455mg iv acetaminophen 600mg po hydrocortisone 250mg iv and furosemide 20mg iv will be given 30 minutes before cell infusion
5512PBSCs will be infused via saline infusion set without in-line filters 5513Vital 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
5514Following medications should not be administered simultaneously with PBSCs 55141Lipid-containing total parenteral nutrition fluid 55142Conventional or liposomal amphotericin 56 SUPPORTIVE CARE 561 Recombinant human G-CSF rhG-CSF 450 in 100 mL of D5W will be infused intravenously over 30 minutes from day 5 till ANC3000
562 Ciprofloxacin 500mg will be given po twice a day for selective bowel decontamination from day 1 till ANC3000 With the first fever spike ciprofloxacin can be replaced with broad spectrum antibiotics
563 Micafungin 50mg will be infused intravenously once a day from day1 till ANC3000
564 Acyclovir 250mgm2 will be infused twice a day from day1 till ANC3000
565 In case of oral mucositis sodium bicarbonatesaline mouthwash will be applied four times a day until resolved
566 Clotrimazole or Canesten powder can be applied to groin axilla and perianal area twice a day from day-8 until engraftment
567 All cellular blood products must be transfused after leukocyte filtration and irradiation
568 For woman of childbearing potential adequate consultation for ovarian protection can be sought For man who intend to have children in future sperm banking can be recommended and performed
57 EVALUATION DURING TREATMENT 571 CBC with differential count ALTAST bilirubin with BUNCr and electrolyte will be checked once daily
572 Chemical battery with BUNphosphorus LDH and level of magnesium will be checked three times a week
573 Coagulation battery with fibrinogend-dimer will be checked at day 0 7 14 21 and once a week thereafter until discharge
574 Protein C antithrombin III t-PA antigen and PAI-1 antigen will be checked at day 0 7 14 and 21
575 Urinalysis will be checked once a week 576 Chest X-ray will be checked once a week routinely and more frequently according to patients condition
577 Blood galactomannan aspergillosis antigen GM assay can be recommended to be checked once a week until ANC3000 according to the physicians decision
58 POST-HCT FOLLOW-UP INCLUDING MRD MONITORING 581 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
582 Toxicities related to treatment will be assessed and reported according to NCI CTCAE v30
583 Minimal residual disease MRD monitoring with RQ-PCR for AML1ETO or CBFβMYH11 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
584 If RQ-PCR is not available RT-PCR andor FISH can be used for MRD monitoring
521 PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy
522 For mobilization recombinant human granulocyte- colony-stimulating factor G-CSF Filgrastim will be given subcutaneously at a dose of 10 mcgkg from day 9 of the 2nd HDAC cycle until the completion of harvesting
523 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
524 Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 02 x 109mm3 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 106kg in terms of body weight of recipient is collected
525 If adequate numbers of CD34 cells are not collected the 3rd HDAC chemotherapy will be done and mobilizationharvest procedure will be repeated
526 Stem cells harvested from patient will be frozen in liquid nitrogen tank for future autologous HCT cell infusion
53PRETRANSPLANT WORKUP FOR AUTOLOGOUS HCT 531 Pre-workup for checking the current disease status and feasibility for autologous HCT will be performed before the conditioning and infusion of autologous HCT
532 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
533 Pretransplant workup tests are listed in Appendix IV
54 CONDITIONING REGIMEN FOR AUTOLOGOUS HCT 541 On admission 5411Menstruating women will be given norethindrone Norlutate 10mg po daily until platelet count is consistently over 100000 mcL
5412Actual body weight ABW for busulfan will be calculated using following guidelines 54121If ABW is less or equal to ideal body weight IBW use ABW 54122If ABW is greater than IBW but ABW is within 120 of IBW use IBW 54123If ABW is 120 or greater than IBW use IBW25 ABW-IBW 54124IBWideal body weight will be calculated in 541241Male 50 kg 23kg heightinch-60 541242Female 455kg 23kg heightinch-60 5412431inch254cm 542 On day -8 preparation drugs will be administered to patient as below 5421Hydration with 09 normal saline will be started at 6PM and infused continuously at a rate of 100mLhr through day -4
5422Allopurinol 300mgday will be taken po once a day from day-8 to -2 5423Heparin 100 Ukgday in normal saline 500 mL will be infused continuously at a rate of 20mLhr through day 20 6pm Heparin should be discontinued if there is clinically significant bleeding or aPTT level exceeds 12 time of the upper normal limit
5424Dilantin 15mgkg ABW in normal saline 300cc will be infused continuously at a rate of 200mLhr at 8PM and then 200mg will be taken po 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 mgL
543 From day-7 conditioning drug will be administered to patient as below 5431Busulfan 32mgkgday 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
5432Etoposide 200mgm2day 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
5433Antiemetics such as serotonin antagonist or lorazepam are allowed
55 AUTOLOGOUS PBSCS INFUSION 551 Autologous PBSCs will be infused on day0 5511Premedication including pheniramine maleate avil 455mg iv acetaminophen 600mg po hydrocortisone 250mg iv and furosemide 20mg iv will be given 30 minutes before cell infusion
5512PBSCs will be infused via saline infusion set without in-line filters 5513Vital 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
5514Following medications should not be administered simultaneously with PBSCs 55141Lipid-containing total parenteral nutrition fluid 55142Conventional or liposomal amphotericin 56 SUPPORTIVE CARE 561 Recombinant human G-CSF rhG-CSF 450 in 100 mL of D5W will be infused intravenously over 30 minutes from day 5 till ANC3000
562 Ciprofloxacin 500mg will be given po twice a day for selective bowel decontamination from day 1 till ANC3000 With the first fever spike ciprofloxacin can be replaced with broad spectrum antibiotics
563 Micafungin 50mg will be infused intravenously once a day from day1 till ANC3000
564 Acyclovir 250mgm2 will be infused twice a day from day1 till ANC3000
565 In case of oral mucositis sodium bicarbonatesaline mouthwash will be applied four times a day until resolved
566 Clotrimazole or Canesten powder can be applied to groin axilla and perianal area twice a day from day-8 until engraftment
567 All cellular blood products must be transfused after leukocyte filtration and irradiation
568 For woman of childbearing potential adequate consultation for ovarian protection can be sought For man who intend to have children in future sperm banking can be recommended and performed
57 EVALUATION DURING TREATMENT 571 CBC with differential count ALTAST bilirubin with BUNCr and electrolyte will be checked once daily
572 Chemical battery with BUNphosphorus LDH and level of magnesium will be checked three times a week
573 Coagulation battery with fibrinogend-dimer will be checked at day 0 7 14 21 and once a week thereafter until discharge
574 Protein C antithrombin III t-PA antigen and PAI-1 antigen will be checked at day 0 7 14 and 21
575 Urinalysis will be checked once a week 576 Chest X-ray will be checked once a week routinely and more frequently according to patients condition
577 Blood galactomannan aspergillosis antigen GM assay can be recommended to be checked once a week until ANC3000 according to the physicians decision
58 POST-HCT FOLLOW-UP INCLUDING MRD MONITORING 581 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
582 Toxicities related to treatment will be assessed and reported according to NCI CTCAE v30
583 Minimal residual disease MRD monitoring with RQ-PCR for AML1ETO or CBFβMYH11 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
584 If RQ-PCR is not available RT-PCR andor FISH can be used for MRD monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None