Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis

• ClinicalTrials.gov Identifier: NCT00622895
• Recruitment Status: Completed
• First Posted: February 25, 2008
• Results First Posted: June 4, 2018
• Last Update Posted: June 4, 2018
• Sponsor: Fred Hutchinson Cancer Center
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): George Georges, Fred Hutchinson Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Systemic Scleroderma; Severe Systemic Sclerosis
• Interventions: Drug: fludarabine phosphate; Drug: Mycophenolic Acid; Drug: tacrolimus; Radiation: total-body irradiation; Procedure: bone marrow transplantation; Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis; Other: flow cytometry; Procedure: biopsy
• Enrollment: 3

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description	Conditioning regimen; Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .; Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.; Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.; Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.; Day 0: UCB infusion ( 2 units) Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365. Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks.
Period Title: Overall Study
Started	3
Completed	3
Not Completed	0

Baseline Characteristics

Arm/Group Title		Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description		Conditioning regimen; Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .; Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.; Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.; Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.; Day 0: UCB infusion ( 2 units) Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365. Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks.
Overall Number of Baseline Participants		3
Baseline Analysis Population Description		Patients are evaluated pre-transplant for assessment of eligibility criteria including chest CT, pulmonary function tests, echocardiogram, bone marrow biopsy, and physical examination as well as standard pre-transplant infectious disease markers.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	3 100.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	3 participants
		44; (21 to 51)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants
	Female	2 66.7%
	Male	1 33.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	3 participants
		3

Outcome Measures

1. Primary Outcome

Title	Event-free Survival (EFS)
Description	The events will be defined as any one of the following: death; respiratory failure; renal failure, as defined by chronic dialysis > or = 6 months or kidney transplantation; occurrence of cardiomyopathy, confirmed by clinical CHF (New York Class III or IV) or LVEF < 30% by echocardiogram, sustained for at least 3 months despite therapy; organ dysfunction specific events must be documented on at least two occasions > or = 3 months apart, or sustained for a 3-month period (documented from the first occurrence).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

UCB transplant recipients

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	1 33.3%

2. Secondary Outcome

Title	EFS
Description	event-free survival after umbilical cord blood transplant
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment: Allogeneic UCB After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive hematopoietic cell transplantation on day 0. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	1 33.3%

3. Secondary Outcome

Title	Overall Survival
Description	Event is defined as death due to any cause.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

survival of patients after UCB

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	1 33.3%

4. Secondary Outcome

Title	Treatment-related Mortality
Description	Defined as death occurring at any time after start of allogeneic HCT and definitely or probably resulting from treatment given in the study and not associated with disease progression.
Time Frame	From time of transplant to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	2 66.7%

5. Secondary Outcome

Title	Regimen-related Toxicity (Greater Than or Equal to Grade III) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Description	Grades 3, 4 and 5 adverse events will be tracked from the start of mobilization or conditioning until day +100 after transplant or until patient departure from the center, whichever occurs first. Certain adverse events are usual and expected after transplant and will only be reported if they are > Grade 4. Some Grade 4 events that are routinely expected (i.e. pancytopenia) will not be reported.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

3 patients received umbilical cord blood (UCB) transplant.

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
Renal failure	1 33.3%
Diffuse alveolar hemorrhage	1 33.3%
Pneumonitis	1 33.3%

6. Secondary Outcome

Title	The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections
Description	The percent of participants with definite and probable viral, fungal, and bacterial infections after transplant
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	2 66.7%

7. Secondary Outcome

Title	Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)
Description	The questionnaire includes measure of quality of life and measure of the scale of skin tightness, activity level and function specifically designed for patients with systemic sclerosis
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

One patient completed the pre-transplant and 5 year post transplant SHAQ (scleroderma health assessment questionnaire). Score range from 0 to 3. Minimum score: Score of 0 is excellent health. Maximum score: score of 3 is most severely impaired, poor quality of life.

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Conditioning regimen; Day -6: cyclophosphamide 50mg/kg. MESNA will be given for bladder prophylaxis .; Day -6, -5, -4: Horse ATG 30mg/kg IV x 3 days.; Days -6, -5, -4, -3 and -2: Fludarabine 40 mg/m2/day IV over one hour x 5 days.; Day -1: TBI 200 cGy at 6-7 cGy/min from a linear accelerator TBI.; Day 0: UCB infusion ( 2 units) Day -3: Commence tacrolimus at 0.03 mg/kg/day continuous IV infusion until the patient is tolerating oral intake then convert to oral PO b.i.d., continue to day +180 and taper to day +365. Day 0: After UCB transplant on day 0, mycophenolate mofetil will be given 1gm IV t.i.d. until the patient is tolerating oral intake and can convert to 1 gram PO T.I.D. Stop MMF at Day +30, if no acute GVHD, until day +100, and then taper 11% week over 8 weeks.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: units on a scale
pre-transplant SHAQ	1.125
5 year post transplant	0.125
pre-transplant Raynaud symptoms	3
5 year post transplant Raynaud symptoms	0.5
pre-transplant Finger ulcer symptoms	3
5 year post-transplant Finger ulcer symptoms	0
pre-transplant Overall health symptoms	2.5
5 year post-transplant overall health symptoms	0.2

8. Secondary Outcome

Title	Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36)
Description	The Medical Outcome Short Form (36) Health Survey instrument (SF-36) is a general assessment of health quality of life with eight components: physical functioning, role limitations due to physical health, pain index, general health perceptions, vitality, social functioning, role limitations due to emotional problems and Mental Health Index. Each domain is positively scored, indicating that higher scores are associated with positive outcome.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Pre-transplant (baseline) evaluation of physical functioning. Score from 0 to100 with 0 perfect health and 100 poor health.

The pre-transplant (baseline) evaluation was completed by study participant. The participant did not complete the 5 year post transplant evaluation.

The 5 year post-transplant SF32 form was not completed by the patient.

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: units on a scale
SF-36 pretransplant overall score	49.3
pretransplant limitations due to physical health	50
pretransplant limitations due to emotional health	50

9. Secondary Outcome

Title	Skin Score
Description	The skin score measure is a scale: the name of the scale is the modified Rodnan skin score (mRSS). Total score of mRSS is from 0 to 51. Higher values represents worse skin score. Highest value is 51, represents very hidebound tight thick skin. Lowest value is 0, represent normal skin, no tightness.
Time Frame	Up to 5 years post-transplant

Outcome Measure Data

Analysis Population Description

One patient was evaluated at baseline and at 5 years post-transplant. Skin score was evaluated using modified Rodnan skin score (mRSS).

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: units on a scale (mRSS)
Pre-transplant (baseline) skin score	17
5 year post-transplant skin score	4

10. Secondary Outcome

Title	Incidence of Graft Rejection
Description	Engraftment is defined as achieving > 5% donor peripheral blood T cell chimerism by Day 56 after HCT. Primary graft failure is defined as a donor peripheral blood T cell chimerism peak of < 5% by Day 56 post-HCT. Methodological requirements for chimerism are as defined by institutional standard of practice. Secondary Graft Failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood T cell chimerism < 5% as demonstrated by a chimerism assay
Time Frame	Up to day +56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

11. Secondary Outcome

Title	Incidence and Severity of Graft-versus-host Disease (GVHD)
Description	The grading of acute and chronic GVHD will follow previously published guidelines and according to institutional standard of practice but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and SSc involve the skin and the gastrointestinal tract, all diagnostic biopsies of these organs will be centrally reviewed by a study pathologist.
Time Frame	Up to 5 years post-transplant

Outcome Measure Data

Analysis Population Description

1 patient out of the 3 patients enrolled was evaluable for both acute and chronic GVHD. The grade of acute GVHD ranges from 0 to 4. Minimum score of 0 is normal or no GVHD. Maximum score of 4 is fatal GVHD.

Chronic GVHD minimum score is 0 (none), maximum score 3: extensive and severe.

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: units on a scale
acute GVHD severity maximum grade	2
chronic GVHD maximum grade	2

12. Secondary Outcome

Title	Incidence of Disease-modifying Antirheumatic Drugs (DMARDs) Initiated Post Transplant to Modify Disease
Description	Percent of patients treated with DMARDS after allogeneic transplant in order to treat scleroderma disease signs and symptoms.
Time Frame	Up to 5 years post-transplant

Outcome Measure Data

Analysis Population Description

3 patients enrolled were evaluable.

Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description:	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
Overall Number of Participants Analyzed	3
Measure Type: Count of Participants; Unit of Measure: Participants
participants requiring DMARDs	0 0.0%
participants evaluable	3 100.0%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
Arm/Group Description	Patients receive fludarabine phosphate IV on days -4, -3 and -2, cyclophosphamide IV over 1-2 hours on days -6, -5, 3, and 4, and undergo low-dose TBI on day -1. Patients receive bone marrow transplantation on day 0. Patients then receive cyclophosphamide IV on days +3 and +4, and beginning day +5 they start tacrolimus orally (PO) and mycophenolic acid. fludarabine phosphate: Given IV Mycophenolic Acid: Given PO tacrolimus: Given PO total-body irradiation: Undergo TBI bone marrow transplantation: Undergo transplantation reduced intensity allogeneic hematopoietic stem cell transplantation: Undergo transplantation quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies biopsy: Punch biopsy of skin involved with scleroderma cyclophosphamide: Given IV
All-Cause Mortality
	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
	Affected / at Risk (%)
Total	2/3 (66.67%)
Serious Adverse Events
	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
	Affected / at Risk (%)	# Events
Total	2/3 (66.67%)
Renal and urinary disorders
Renal failure †	1/3 (33.33%)	1
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage †	1/3 (33.33%)	1
Pneumonitis † [1]	1/3 (33.33%)	1
† Indicates events were collected by systematic assessment; [1] Hypoxia
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment: Allogeneic HCT After Reduced Intensity Conditioning
	Affected / at Risk (%)	# Events
Total	1/3 (33.33%)
Skin and subcutaneous tissue disorders
GVHD † [1]	1/3 (33.33%)	3
† Indicates events were collected by systematic assessment; [1] Skin graft versus host disease

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: George E. Georges MD
• Organization: Fred Hutchinson Cancer Research Center
• Phone: 206-667-6886
• EMail: ggeorges@fredhutch.org

• Responsible Party: George Georges, Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT00622895
• Other Study ID Numbers: 2067.00; NCI-2011-01352 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); R01AI041721 ( U.S. NIH Grant/Contract )
• First Submitted: February 22, 2008
• First Posted: February 25, 2008
• Results First Submitted: August 16, 2017
• Results First Posted: June 4, 2018
• Last Update Posted: June 4, 2018