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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00593554
Recruitment Status : Terminated (Slow accrual)
First Posted : January 15, 2008
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplasia
Chronic Myeloid Leukemia
Interventions: Radiation: Total Body Irradiation
Drug: Thiotepa
Drug: Fludarabine
Biological: Rabbit ATG
Drug: Palifermin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Without Paliferim

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Treatment With Palifermin

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2


Participant Flow:   Overall Study
    Treatment Without Paliferim   Treatment With Palifermin
STARTED   3   5 
COMPLETED   0   0 
NOT COMPLETED   3   5 
Death                1                2 
Physician Decision                0                1 
Withdrawal by Subject                1                0 
Disease Progression                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Without Paliferim

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Treatment With Palifermin

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Total Total of all reporting groups

Baseline Measures
   Treatment Without Paliferim   Treatment With Palifermin   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   5   8 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3 100.0%      5 100.0%      8 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.6  (13.73)   45.9  (12.21)   44.6  (11.91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  20.0%      1  12.5% 
Male      3 100.0%      4  80.0%      7  87.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      3 100.0%      5 100.0%      8 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  33.3%      2  40.0%      3  37.5% 
White      2  66.7%      3  60.0%      5  62.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation   [ Time Frame: thru 6 months after transplant ]

2.  Secondary:   Regimen-related Toxicity   [ Time Frame: Up to 1 year ]

3.  Secondary:   Time to Neutrophil Engraftment   [ Time Frame: Transplant (Day 0) up to 1 year ]

4.  Secondary:   Time to Platelet Engraftment   [ Time Frame: Transplant (Day 0) up to 1 year ]

5.  Secondary:   Acute Graft vs. Host Disease (GvHD)   [ Time Frame: Up to 1 year ]

6.  Secondary:   Chronic Graft vs. Host Disease (GvHD)   [ Time Frame: Up to 1 year ]

7.  Secondary:   Frequency of Infection   [ Time Frame: Day 0 through 1 year post transplantation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sherif Farag
Organization: IndianaU
phone: 317-278-0460
e-mail: ssfarag@iu.edu



Responsible Party: Sherif S. Farag, Indiana University
ClinicalTrials.gov Identifier: NCT00593554     History of Changes
Other Study ID Numbers: 0704-19 IUCRO-0184
First Submitted: January 4, 2008
First Posted: January 15, 2008
Results First Submitted: March 12, 2018
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018