Protocol Index	

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IP RESEARCH BMT CTN 1705 (H-46470)	

Types:      Research Oncology Treatment
Synonyms:  AAT, GVHD, OF ALPHA 1 - ANTITRYPSIN, H46470

Treatment Cycle	Repeat 1 time	Cycle length: 176 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Document complete acute GVHD staging and grading (including assessment of rash, diarrhea, and nausea/vomiting, and GVHD prophylaxis in chart.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug. Post-infusion labs  will be collected 15-45 minutes after completion of infusion; 
o Tubes provided by Research Coordinator;  
o Please call research coordinator, Davis So at 713-363-7176, to pick up samples once collected.
			Nursing Orders
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Once	Occurrences: --			Line Flush
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Flush the line before and after administration of investigational drug. If multi-lumen catheter is used, where possible it is recommended that one port be designated for IMP infusion only and infusions through all other ports be paused during infusion and resumed after completion of post-infusion flush.			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Anaphylactic precautions: Keep medications at the bedside to administer per physician's orders.
			Emergency Medications
  	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep medication at the bedside to administer per physician's orders		  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep medication at the bedside to administer per physician's orders.		  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: intramuscular	once PRN	Start: S			Instructions:	Keep medication at the bedside to administer per physician's orders			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: Until discontinued	Occurrences: --	Comments:	Oxygen at bedside during infusion until completed.
			Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 4	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 7	Perform every 1 day x1		Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --				Day 8	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Document complete acute GVHD staging and grading (including assessment of rash, diarrhea, and nausea/vomiting, and GVHD prophylaxis in chart.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug;  
o Tubes provided by Research Coordinator;  
o Please call research coordinator Davis So at 713-363-7176, to pick up samples once collected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 12	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 14	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Document complete acute GVHD staging and grading (including assessment of rash, diarrhea, and nausea/vomiting, and GVHD prophylaxis in chart.
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --				Day 16	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug. Post-infusion labs  will be collected 15-45 minutes after completion of infusion; 
o Tubes provided by Research Coordinator;  
o Please call research coordinator, Davis So at 713-363-7176, to pick up samples once collected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
			Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --				Day 20	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 21	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Document complete acute GVHD staging and grading (including assessment of rash, diarrhea, and nausea/vomiting, and GVHD prophylaxis in chart.
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --				Day 24	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug;  
o Tubes provided by Research Coordinator;  
o Please call research coordinator Davis So at 713-363-7176, to pick up samples once collected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 28	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Document complate acute and chronic GVHD grading.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug. Post-infusion labs  will be collected 15-45 minutes after completion of infusion; 
o Tubes provided by Research Coordinator;  
o Please call research coordinator, Davis So at 713-363-7176, to pick up samples once collected.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Serum pregnancy test not needed if male or a female subjects meeting one of below criteria: 
Age GREATER than 60, aged 45 to 60 with amenorrhea for GREATER than 1 year, surgically sterile for at least 3 months before prior to study.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	Only if women of childbearing potential; confirm 1 of below before collecting:
Age GREATER than 60, aged 45 to 60  with amenorrhea for GREATER than 1 year, or surgically sterile for at least 3 months before prior to study.
			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
			Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --				Days 35,42,49	Perform every 7 days x3		Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Document complete acute GVHD staging and grading (including assessment of rash, diarrhea, and nausea/vomiting, and GVHD prophylaxis in chart.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
				Day 56	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Document complate acute and chronic GVHD grading.
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	o immediately prior to infusion; 
o 10 minutes (+/- 5 minutes) after start of infusion; 
o 20 minutes (+/-10 minutes) post-infusion.
		  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Volume of infusion, date, start and stop time, and interruptions of infusion if any MUST be documented.
		  	ASSESS	Interval: Once	Occurrences: --	Comments:	Assess: patient for immediate reactions: 1) Allergic reactions - If patient experiences a grade 3 or 4 infusion related reaction, the infusion should be held and reaction managed per institutional standards.  Once resolved, the infusion can be restarted at half the rate.  2) Anaphylaxis - Administration should be discontinued immediately and should not be resumed. 3) Notify research team:  Dr. Hill, Davis So at 713-363-7176
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Serum pregnancy test not needed if male or a female subjects meeting one of below criteria: 
Age GREATER than 60, aged 45 to 60 with amenorrhea for GREATER than 1 year, surgically sterile for at least 3 months before prior to study.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	Only if women of childbearing potential; confirm 1 of below before collecting:
Age GREATER than 60, aged 45 to 60  with amenorrhea for GREATER than 1 year, or surgically sterile for at least 3 months before prior to study.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	o Collect pre-infusion study samples just prior to starting infusion of study drug. Post-infusion labs  will be collected 15-45 minutes after completion of infusion; 
o Tubes provided by Research Coordinator;  
o Please call research coordinator, Davis So at 713-363-7176, to pick up samples once collected.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
☑	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 25 mg IV. Administer 30 minutes prior to each dose.		☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	OR Diphenhydramine 50 mg oral. Administer 30 minutes prior to each dose.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S			Instructions:	OPTIONAL. Administer 30 minutes prior to each dose.			Medications
  	INV-Alpha1-Antitrypson or Placebo infusion (BMT-CTN-1705/H-46470/HILL)	Dose: 0.08 mL/kg/min	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	May contain active AAT or matching placebo (albumin + D5W) in blinded manner. Infuse using the provided 5 micron inline filter.  Rate no more than 0.08 mL/Kg/MINUTE; rate may be decreased.  Stable for 12 hours at room temp. Change filter after approximately every 100 mL solution is infused, to prevent clogging issue.
			Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --				Day 86	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Document complate acute and chronic GVHD grading.
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --					
Follow Up 6 Months	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Document complate acute and chronic GVHD grading.
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --					
Follow Up 12 Months	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Document complate acute and chronic GVHD grading.
			Labs
  	HEPATIC FUNCTION PANEL	Interval: Once	Occurrences: --