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GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT02360111
Recruitment Status : Terminated (Lack of accrual)
First Posted : February 10, 2015
Results First Posted : November 8, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Intervention Drug: Cyclophosphamide
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
70
(64 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 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
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title # GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)
Hide Description Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol terminated prematurely due to low accrual
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description:

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Disease-free Survival
Hide Description DFS is defined as the minimum interval of time to relapse/recurrence, to death or to the last follow-up, from the time of transplant
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol terminated prematurely due to low accrual
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description:

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as time from transplant to death or last follow-up.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol terminated prematurely due to low accrual
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description:

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title # Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible.
Hide Description Renal insufficiency is defined as a calculated eGFR <60 ml/min/1.73m2. Those with a eGFR < 30 ml/min/1.73m2 will be considered ineligible.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol terminated prematurely due to low accrual
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description:

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title The Occurrence of Life-threatening Opportunistic Infections
Hide Description will be evaluated according to the criteria established by BMT CTN , and will be correlated with the level of immune recovery.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol terminated prematurely due to low accrual
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description:

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Post Transplant Cyclophosphamide
Hide Arm/Group Description

Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.

Cyclophosphamide
All-Cause Mortality
Post Transplant Cyclophosphamide
Affected / at Risk (%)
Total   2/3 (66.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Post Transplant Cyclophosphamide
Affected / at Risk (%)
Total   3/3 (100.00%) 
Cardiac disorders   
Pericardial effusion †  1/3 (33.33%) 
Gastrointestinal disorders   
Diarrhea †  1/3 (33.33%) 
General disorders   
Edema limbs †  1/3 (33.33%) 
Infections and infestations   
Lung infection †  2/3 (66.67%) 
Salivary gland infection †  1/3 (33.33%) 
Sepsis †  3/3 (100.00%) 
Nervous system disorders   
Encephalopathy †  1/3 (33.33%) 
Psychiatric disorders   
Delirium †  1/3 (33.33%) 
Renal and urinary disorders   
Acute kidney injury †  1/3 (33.33%) 
Urinary retention †  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion †  1/3 (33.33%) 
Respiratory failure †  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Purpura †  1/3 (33.33%) 
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Post Transplant Cyclophosphamide
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anemia †  3/3 (100.00%) 
Gastrointestinal disorders   
Diarrhea †  1/3 (33.33%) 
General disorders   
Edema limbs †  1/3 (33.33%) 
Infections and infestations   
Lung infection †  1/3 (33.33%) 
Sepsis †  1/3 (33.33%) 
Investigations   
Lymphocyte count decreased †  3/3 (100.00%) 
Neutrophil count decreased †  3/3 (100.00%) 
Platelet count decreased †  3/3 (100.00%) 
White blood cell decreased †  3/3 (100.00%) 
Aspartate aminotransferase increased †  1/3 (33.33%) 
Blood bilirubin increased †  1/3 (33.33%) 
Creatinine increased †  1/3 (33.33%) 
Metabolism and nutrition disorders   
Hyperkalemia †  2/3 (66.67%) 
Hypokalemia †  2/3 (66.67%) 
Hyperglycemia †  1/3 (33.33%) 
Hypocalcemia †  1/3 (33.33%) 
Hyponatremia †  1/3 (33.33%) 
Hypophosphatemia †  1/3 (33.33%) 
Nervous system disorders   
Encephalopathy †  1/3 (33.33%) 
Syncope †  1/3 (33.33%) 
Psychiatric disorders   
Delirium †  1/3 (33.33%) 
Renal and urinary disorders   
Acute kidney injury †  1/3 (33.33%) 
Urinary retention †  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory failure †  1/3 (33.33%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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: Dr. Ann Jakubowski, Ph.D., MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5013
EMail: jakubowa@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02360111     History of Changes
Other Study ID Numbers: 14-273
First Submitted: February 5, 2015
First Posted: February 10, 2015
Results First Submitted: October 1, 2018
Results First Posted: November 8, 2018
Last Update Posted: July 24, 2019