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Trial record 31 of 1322 for:    Hematologic neoplasm

Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01244906
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : March 17, 2015
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematologic Neoplasms
Intervention Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Period Title: Overall Study
Started 26
Completed 18
Not Completed 8
Reason Not Completed
Death             2
Progression of disease post treatment             6
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants
61
(25 to 73)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  80.8%
>=65 years
5
  19.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
10
  38.5%
Male
16
  61.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  19.2%
White
21
  80.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
26
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Incidence of GVHD
Hide Description To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
12
2.Secondary Outcome
Title Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment
Hide Description To estimate the incidence of neutrophil and platelet engraftment
Time Frame Approximately Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
26
3.Secondary Outcome
Title Number of Participants With Non-Relapse Mortality
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Number of Patients With Disease Free Survival at 2 Years
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
17
5.Secondary Outcome
Title Number of Patients to Achieve Full Donor Chimerism
Hide Description Characterize rate of achievement of full donor chimerism
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
26
6.Secondary Outcome
Title Number of Patients With Overall Survival at 2 Years.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description:

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reduced Intensity Allogeneic Stem Cell Transplantation
Hide Arm/Group Description

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

All-Cause Mortality
Reduced Intensity Allogeneic Stem Cell Transplantation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reduced Intensity Allogeneic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   10/26 (38.46%)    
Gastrointestinal disorders   
Acute Cholecystitis  1/26 (3.85%)  1
GI bleeding  2/26 (7.69%)  2
Hepatobiliary disorders   
VOD  1/26 (3.85%)  1
Investigations   
Severe Hyperglycemia  1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders   
pneumonia  3/26 (11.54%)  3
pulmonary embolism  1/26 (3.85%)  1
Vascular disorders   
cellulitis  1/26 (3.85%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reduced Intensity Allogeneic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   26/26 (100.00%)    
Blood and lymphatic system disorders   
neutropenia  26/26 (100.00%) 
anemia  26/26 (100.00%) 
enlarged lymph nodes  2/26 (7.69%) 
lymphadenopathy  2/26 (7.69%) 
febrile neutropenia  15/26 (57.69%) 
petechiae  2/26 (7.69%) 
thrombocytopenia  26/26 (100.00%) 
leukopenia  26/26 (100.00%) 
Cardiac disorders   
bradycardia  6/26 (23.08%) 
chest pressure  2/26 (7.69%) 
hypertension  16/26 (61.54%) 
hypotension  13/26 (50.00%) 
orthostatic hypotension  2/26 (7.69%) 
pleuritic chest pain  3/26 (11.54%) 
tachycardia  17/26 (65.38%) 
Ear and labyrinth disorders   
ear fullness/pressure  2/26 (7.69%) 
Eye disorders   
blurry vision  4/26 (15.38%) 
dry eyes  6/26 (23.08%) 
periorbital edema  2/26 (7.69%) 
periorbital redness  2/26 (7.69%) 
Gastrointestinal disorders   
Nausea   24/26 (92.31%) 
abdominal bloating  8/26 (30.77%) 
abdominal cramps  8/26 (30.77%) 
abdominal discomfort/pain  14/26 (53.85%) 
abdominal distention  13/26 (50.00%) 
abdominal tenderness  5/26 (19.23%) 
anorexia/decreased oral intake  11/26 (42.31%) 
ascites  5/26 (19.23%) 
bloody stool  2/26 (7.69%) 
clostridium difficile colitis  4/26 (15.38%) 
constipation  13/26 (50.00%) 
decreased bowel movement frequency  2/26 (7.69%) 
diarrhea  23/26 (88.46%) 
dysphagia  7/26 (26.92%) 
dry lips  2/26 (7.69%) 
dry mouth  9/26 (34.62%) 
epigastric pain  2/26 (7.69%) 
esophagitis  2/26 (7.69%) 
gas/flatulence  3/26 (11.54%) 
GERD  19/26 (73.08%) 
perirectal bleeding/hemorrhage  7/26 (26.92%) 
hemorrhodial edema  2/26 (7.69%) 
hemorrhodial pain  4/26 (15.38%) 
hemorrhoids  7/26 (26.92%) 
hyperactive bowel sounds  6/26 (23.08%) 
stool incontinence  4/26 (15.38%) 
malnutrition  2/26 (7.69%) 
mouth sores  9/26 (34.62%) 
mouth tenderness  10/26 (38.46%) 
mucositis  15/26 (57.69%) 
pain during defication  2/26 (7.69%) 
throat pain  13/26 (50.00%) 
perirectal irritation  4/26 (15.38%) 
perirectal pain  4/26 (15.38%) 
stomatitis  3/26 (11.54%) 
vomiting  21/26 (80.77%) 
General disorders   
"cold sweats"  2/26 (7.69%) 
"cold" feeling  2/26 (7.69%) 
alopecia  3/26 (11.54%) 
chills/rigors  14/26 (53.85%) 
central venous catheter pain  15/26 (57.69%) 
central venous catheter site drainage  5/26 (19.23%) 
central venous catheter site erythema  8/26 (30.77%) 
deconditioning  10/26 (38.46%) 
facial edema  2/26 (7.69%) 
fatigue  22/26 (84.62%) 
fever  20/26 (76.92%) 
lower-extremity edema  17/26 (65.38%) 
lip edema  2/26 (7.69%) 
peripheral edema  3/26 (11.54%) 
seasonal allergies  9/26 (34.62%) 
splenomegaly  2/26 (7.69%) 
taste changes  7/26 (26.92%) 
volume depletion  3/26 (11.54%) 
generalized weakness  15/26 (57.69%) 
Hepatobiliary disorders   
increased alkaline phosphatase  17/26 (65.38%) 
increased alanine aminotransferase  18/26 (69.23%) 
increased aspartate aminotransferase  14/26 (53.85%) 
hyperbilirubinemia  11/26 (42.31%) 
perihepatic ascites  2/26 (7.69%) 
veno-occlusive disease  2/26 (7.69%) 
Immune system disorders   
skin GVHD  11/26 (42.31%) 
gut GVHD  2/26 (7.69%) 
Infections and infestations   
bacteremia  6/26 (23.08%) 
BKV cystitis  12/26 (46.15%) 
cellulitis  3/26 (11.54%) 
CMV reactivation  2/26 (7.69%) 
MRSE bacteremia  3/26 (11.54%) 
staphylococcus epidermis bacteremia  2/26 (7.69%) 
VRE positive  6/26 (23.08%) 
Investigations   
weight gain  5/26 (19.23%) 
weight loss  12/26 (46.15%) 
Metabolism and nutrition disorders   
decreased appetite  18/26 (69.23%) 
decreased fluid intake  5/26 (19.23%) 
electrolyte wasting syndrome  2/26 (7.69%) 
hypercalcemia  4/26 (15.38%) 
hyperglycemia  26/26 (100.00%) 
hyperkalemia  3/26 (11.54%) 
hypernatremia  14/26 (53.85%) 
hypoalbuminemia  20/26 (76.92%) 
hypocalcemia  20/26 (76.92%) 
hypoglycemia  2/26 (7.69%) 
hypokalemia  18/26 (69.23%) 
hypomagnesemia  16/26 (61.54%) 
hyponatremia  9/26 (34.62%) 
metabolic acidosis  2/26 (7.69%) 
steroid-induced diabetes  6/26 (23.08%) 
Musculoskeletal and connective tissue disorders   
arm pain  3/26 (11.54%) 
ataxia  11/26 (42.31%) 
back pain  12/26 (46.15%) 
bilateral knee pain  2/26 (7.69%) 
generalized achiness  7/26 (26.92%) 
hernia  2/26 (7.69%) 
joint aches  3/26 (11.54%) 
leg pain  2/26 (7.69%) 
limited mobility  5/26 (19.23%) 
muscle weakness  2/26 (7.69%) 
hip pain  2/26 (7.69%) 
foot pain  2/26 (7.69%) 
lower-extremity pain  2/26 (7.69%) 
neck pain  2/26 (7.69%) 
pelvic pain  3/26 (11.54%) 
shoulder pain  4/26 (15.38%) 
ribcage tenderness  2/26 (7.69%) 
suprapubic tenderness  2/26 (7.69%) 
Nervous system disorders   
dizziness  9/26 (34.62%) 
drowsiness  12/26 (46.15%) 
headache  16/26 (61.54%) 
lethargy  10/26 (38.46%) 
loss of coordination/balance  5/26 (19.23%) 
neuropathy  7/26 (26.92%) 
restless leg syndrome  2/26 (7.69%) 
sedation  4/26 (15.38%) 
sweats  6/26 (23.08%) 
tremors  5/26 (19.23%) 
unsteady gait  2/26 (7.69%) 
visual changes  4/26 (15.38%) 
Psychiatric disorders   
agitation  3/26 (11.54%) 
anxiety  21/26 (80.77%) 
confusion  2/26 (7.69%) 
depression  13/26 (50.00%) 
flat affect  7/26 (26.92%) 
hallucinations  2/26 (7.69%) 
insomnia  13/26 (50.00%) 
Renal and urinary disorders   
bladder cramping  2/26 (7.69%) 
bladder pain  7/26 (26.92%) 
bladder spasms  6/26 (23.08%) 
benign prostatic hyperplasia  2/26 (7.69%) 
increased creatinine  9/26 (34.62%) 
dysuria  16/26 (61.54%) 
hematuria  12/26 (46.15%) 
nocturia  2/26 (7.69%) 
urinary frequency  15/26 (57.69%) 
urinary hesitancy  3/26 (11.54%) 
urinary incontinence  4/26 (15.38%) 
urinary retention  5/26 (19.23%) 
urinary urgency  6/26 (23.08%) 
urinary tract infection  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
dry cough  17/26 (65.38%) 
coarse breath sounds  3/26 (11.54%) 
decreased breath sounds  10/26 (38.46%) 
epistaxis  8/26 (30.77%) 
hemoptysis  3/26 (11.54%) 
hypoxemic respiratory failure  2/26 (7.69%) 
increased respiration rate  2/26 (7.69%) 
lung crackles  10/26 (38.46%) 
nasal congestion  10/26 (38.46%) 
nasal drainage  7/26 (26.92%) 
pain with breathing  3/26 (11.54%) 
parainfluenza  3/26 (11.54%) 
pleural effusion  6/26 (23.08%) 
pneumonia  5/26 (19.23%) 
post-nasal drip  4/26 (15.38%) 
pulmonary infiltrates  5/26 (19.23%) 
pulmonary nodules  2/26 (7.69%) 
pulmonary opacites  4/26 (15.38%) 
respiratory distress  3/26 (11.54%) 
respiratory insufficiency  5/26 (19.23%) 
rhinorrhea  6/26 (23.08%) 
rhinovirus/URI  7/26 (26.92%) 
rhonchi  5/26 (19.23%) 
sinus congestion  7/26 (26.92%) 
sinus drainage  14/26 (53.85%) 
sinus pressure  3/26 (11.54%) 
chronic sinusitis  4/26 (15.38%) 
sneezing  2/26 (7.69%) 
shortness of breath  15/26 (57.69%) 
wheezing  8/26 (30.77%) 
Skin and subcutaneous tissue disorders   
bruising  10/26 (38.46%) 
diaphoretic skin  2/26 (7.69%) 
dry skin  10/26 (38.46%) 
excoriation  3/26 (11.54%) 
folliculitis  4/26 (15.38%) 
generalized skin erythema  4/26 (15.38%) 
hives  2/26 (7.69%) 
hyperpigmentation  7/26 (26.92%) 
oral erythema  3/26 (11.54%) 
pale skin  3/26 (11.54%) 
penile lesions  3/26 (11.54%) 
pruritus  17/26 (65.38%) 
rash  20/26 (76.92%) 
skin abrasion  3/26 (11.54%) 
skin color changes  3/26 (11.54%) 
skin erythema  3/26 (11.54%) 
skin lesions  4/26 (15.38%) 
skin sensitivity  2/26 (7.69%) 
skin tear  2/26 (7.69%) 
skin tenderness  2/26 (7.69%) 
Vascular disorders   
deep venous thrombosis  2/26 (7.69%) 
fluid overload  9/26 (34.62%) 
facial flushing  4/26 (15.38%) 
hematoma  2/26 (7.69%) 
oral thrush  2/26 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott R. Solomon, MD
Organization: Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
EMail: ssolomon@bmtga.com
Publications:
Layout table for additonal information
Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01244906     History of Changes
Other Study ID Numbers: NSH 911
First Submitted: November 18, 2010
First Posted: November 19, 2010
Results First Submitted: January 29, 2015
Results First Posted: March 17, 2015
Last Update Posted: May 1, 2015