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Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer

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ClinicalTrials.gov Identifier: NCT00787761
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: nonmyeloablative allogeneic HSCT
Enrollment 24
Recruitment Details 24 patients were enrolled between 4/20/2007 and 5/3/2010. Patients who were undergoing transplant at Northside Hospital were potentially eligible.
Pre-assignment Details 29 patients signed consent for this study. 2 patients were initially screen failures but eventually were determined eligible & were treated on study. 1 patient was considered a screen failure due to having an ineligible donor. One patient had progressive disease and one patient had compliance-related issues prohibiting them from particiapting.
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  83.3%
>=65 years
4
  16.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
54.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
11
  45.8%
Male
13
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
only 15 of the patients treated on study had Day 30 chimerism results.
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
12
2.Secondary Outcome
Title T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
20 of the patients treated on this study had Day 90 chimerism drawn.
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
17
3.Secondary Outcome
Title T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
20 of the patients treated on study had chimerism drawn on day 180.
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
19
4.Secondary Outcome
Title Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease
Hide Description number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
23 patients were able to be analyzed for severe gvhd
Arm/Group Title Severe Graft Versus Host Disease
Hide Arm/Group Description:
patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
2
5.Secondary Outcome
Title Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)
Hide Description Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
23 patients were able to be analyzed for severe gvhd
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
13
6.Secondary Outcome
Title Non-relapse Mortality (NRM) at Day 180 Post-transplantation
Hide Description non-relapse mortality refers to the death of a patient for causes other than relapsed disease.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
23 patients were able to be analyzed for NRM at 180 days
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
0
7.Secondary Outcome
Title Disease-free Survival (DFS) at 24 Months
Hide Description Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
23 patients were able to be analyzed for DFS at 24 months
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
13
8.Secondary Outcome
Title Overall Survival (OS) at 24 Months
Hide Description Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
23 patients were able to be analyzed for OS at 24 months
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description:
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Hide Arm/Group Description All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
All-Cause Mortality
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Affected / at Risk (%) # Events
Total   13/24 (54.17%)    
Cardiac disorders   
Cardiac Tamponade  1  1/24 (4.17%)  1
Gastrointestinal disorders   
Abdominal Abcess  1  1/24 (4.17%)  1
GI Bleeding  1  1/24 (4.17%)  1
General disorders   
Fever  1  3/24 (12.50%)  3
Chemotherapy reaction  1  1/24 (4.17%)  1
Death  1  4/24 (16.67%)  4
hospitalization for high dose steroid management  1  1/24 (4.17%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/24 (4.17%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/24 (4.17%)  1
Nervous system disorders   
Altered Mental Status  1  1/24 (4.17%)  1
Renal and urinary disorders   
Acute Renal Failure  1  1/24 (4.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Blood and lymphatic system disorders   
ANC  1  22/24 (91.67%)  22
anemia  1  21/24 (87.50%)  21
blood in stool * 1  3/24 (12.50%)  3
edema  1  16/24 (66.67%)  16
petechiae  1  3/24 (12.50%)  3
swelling (hands and fingers)  1  2/24 (8.33%)  2
thrombocytopenia  1  23/24 (95.83%)  23
WBC (leukocytes)  1  23/24 (95.83%)  23
Cardiac disorders   
Chest discomfort  1  2/24 (8.33%)  2
chest tightness  1  4/24 (16.67%)  4
chest wall pain  1  4/24 (16.67%)  4
hypertension  1  10/24 (41.67%)  10
hypotension  1  4/24 (16.67%)  4
tachycradia  1  9/24 (37.50%)  9
Endocrine disorders   
hypothyroidism  1  2/24 (8.33%)  2
Eye disorders   
blurred vision  1  5/24 (20.83%)  5
dry eye  1  3/24 (12.50%)  3
eye irritation  1  2/24 (8.33%)  2
eye redness  1  2/24 (8.33%)  2
Gastrointestinal disorders   
abdominal cramping  1  7/24 (29.17%)  7
abdominal distension  1  5/24 (20.83%)  5
abdominal pain  1  11/24 (45.83%)  11
anorexia/decreased appetite  1  17/24 (70.83%)  17
constipation  1  9/24 (37.50%)  9
diarrhea  1  21/24 (87.50%)  21
dry mouth  1  3/24 (12.50%)  3
dysphagia  1  6/24 (25.00%)  6
flatulence  1  3/24 (12.50%)  3
Gastroesophogeal Reflux disease (GERD)  1  20/24 (83.33%)  20
hemorrhoids  1  2/24 (8.33%)  2
mucositis  1  11/24 (45.83%)  11
nausea  1  22/24 (91.67%)  22
oral sensitivity  1  7/24 (29.17%)  7
poor appetite * 1  3/24 (12.50%)  3
taste alteration  1  3/24 (12.50%)  3
throat pain  1  5/24 (20.83%)  5
vomiting  1  20/24 (83.33%)  20
General disorders   
chills  1  17/24 (70.83%)  17
dizziness  1  9/24 (37.50%)  9
drowsy  1  7/24 (29.17%)  7
Facial flushing  1  6/24 (25.00%)  6
fatigue  1  19/24 (79.17%)  19
fever  1  20/24 (83.33%)  20
generalized pain  1  7/24 (29.17%)  7
headache  1  21/24 (87.50%)  21
hiccups * 1  2/24 (8.33%)  2
hyperglycemia  1  20/24 (83.33%)  20
insomnia  1  10/24 (41.67%)  10
lethargy  1  4/24 (16.67%)  4
night sweats  1  5/24 (20.83%)  5
restless  1  2/24 (8.33%)  2
rigors  1  16/24 (66.67%)  16
weakness  1  7/24 (29.17%)  7
weight gain  1  2/24 (8.33%)  2
weight loss  1  6/24 (25.00%)  6
Hepatobiliary disorders   
hyperbilirubinemia  1  10/24 (41.67%)  10
Infections and infestations   
BK virus  1  3/24 (12.50%)  3
Clostridium difficile  1  2/24 (8.33%)  2
CMV  1  4/24 (16.67%)  4
folliculitis  1  3/24 (12.50%)  3
MRSE  1  4/24 (16.67%)  4
pneumonia  1  2/24 (8.33%)  2
thrush  1  3/24 (12.50%)  3
Metabolism and nutrition disorders   
Alk Phos  1  18/24 (75.00%)  18
ALT  1  17/24 (70.83%)  17
AST  1  18/24 (75.00%)  18
dehydration  1  3/24 (12.50%)  3
hyperkalemia  1  18/24 (75.00%)  18
hypermagnesemia  1  20/24 (83.33%)  20
hypernatremia  1  5/24 (20.83%)  5
hyperphosphatemia  1  2/24 (8.33%)  2
hypoalbuminemia * 1  23/24 (95.83%)  23
hypocalcemia  1  19/24 (79.17%)  19
hypoglycemia  1  5/24 (20.83%)  5
hypokalemia  1  18/24 (75.00%)  18
hypomagnesemia  1  20/24 (83.33%)  20
hyponatremia  1  18/24 (75.00%)  18
hypophosphatemia  1  4/24 (16.67%)  4
Musculoskeletal and connective tissue disorders   
arthralgia  1  3/24 (12.50%)  3
back pain  1  10/24 (41.67%)  10
bone pain  1  5/24 (20.83%)  5
fall  1  2/24 (8.33%)  2
hip pain  1  2/24 (8.33%)  2
joint pain  1  3/24 (12.50%)  3
lower extremity pain  1  6/24 (25.00%)  6
myalgia  1  4/24 (16.67%)  4
neck pain  1  3/24 (12.50%)  3
numbness  1  4/24 (16.67%)  4
shoulder pain  1  2/24 (8.33%)  2
Nervous system disorders   
altered mental status  1  2/24 (8.33%)  2
confusion  1  4/24 (16.67%)  4
depression  1  11/24 (45.83%)  11
diaphoresis  1  2/24 (8.33%)  2
flat affect  1  3/24 (12.50%)  3
tremors  1  5/24 (20.83%)  5
unsteadiness  1  3/24 (12.50%)  3
Renal and urinary disorders   
creatinine  1  12/24 (50.00%)  12
dysuria  1  7/24 (29.17%)  7
hematuria  1  2/24 (8.33%)  2
nocturia  1  3/24 (12.50%)  3
urinary frequency  1  8/24 (33.33%)  8
urinary hesitancy  1  3/24 (12.50%)  3
urinary incontinence  1  3/24 (12.50%)  3
urinary urgency  1  3/24 (12.50%)  3
Respiratory, thoracic and mediastinal disorders   
coarse breath sounds  1  2/24 (8.33%)  2
cough  1  16/24 (66.67%)  16
diminished breath sounds  1  2/24 (8.33%)  2
dyspnea  1  17/24 (70.83%)  17
hypoxia  1  2/24 (8.33%)  2
post-nasal drip * 1  4/24 (16.67%)  4
rhinorrhea  1  4/24 (16.67%)  4
seasonal allergies  1  3/24 (12.50%)  3
sinus congestion  1  8/24 (33.33%)  8
Skin and subcutaneous tissue disorders   
CVC erythema  1  2/24 (8.33%)  2
dry skin * 1  7/24 (29.17%)  7
erythema  1  7/24 (29.17%)  7
lip lesion  1  2/24 (8.33%)  2
Peeling of skin  1  2/24 (8.33%)  2
prurutis  1  11/24 (45.83%)  11
rash  1  11/24 (45.83%)  11
skin tenderness  1  2/24 (8.33%)  2
Social circumstances   
agitation  1  4/24 (16.67%)  4
anxiety  1  19/24 (79.17%)  19
Surgical and medical procedures   
Central venous catheter (CVC) discomfort  1  8/24 (33.33%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Asad Bashey, MD, PhD, Principal Investigator
Organization: Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Publications:
Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT00787761     History of Changes
Other Study ID Numbers: CDR0000618483
BMTGG-NSH-807
First Submitted: November 7, 2008
First Posted: November 10, 2008
Results First Submitted: July 9, 2012
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012