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Trial record 31 of 34 for:    "Leukemia" | "Pentostatin"

A Phase II Study of Umbilical Cord Blood Transplantation

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ClinicalTrials.gov Identifier: NCT00676806
Recruitment Status : Terminated (Slow accrual)
First Posted : May 13, 2008
Results First Posted : July 22, 2016
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Multiple Myeloma
Aplastic Anemia
Interventions Biological: Umbilical Cord Blood After Myeloablative Conditioning
Biological: Umbilical Cord Blood After Reduced-Intensity Conditioning
Enrollment 7
Recruitment Details  
Pre-assignment Details One subject signed consent but did not receive a transplant, so was dropped from the study and was not assigned to either arm.
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
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Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning

Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0.

Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.

Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning Total
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Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning

Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0.

Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.

Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
43  (8.1) 62.6  (2.3) 52.8  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
1
  33.3%
2
  66.7%
3
  50.0%
Male
2
  66.7%
1
  33.3%
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Number of Participants With Neutrophil Engraftment
Hide Description Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning
Time Frame +45 and 90 days
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Hide Analysis Population Description
Only 2 subjects were evaluable from each group at the +45 day mark. The same number were evaluable at the +90 day mark.
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
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Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.

2/2 evaluable subjects engrafted at +45 and +90 days.

Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

1/2 evaluable subjects engrafted at +45 and +90 days.

Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: participants
2 1
2.Secondary Outcome
Title Proportion of Subjects With Platelet Engraftment
Hide Description Proportion of patients engrafting by days +45, +90, and +180.
Time Frame +45, 90, and 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
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Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: participants
Platelet Engraftment +45 days 0 2
Platelet Engraftment +90 days 0 0
Platelet Engraftment +180 days 1 0
3.Secondary Outcome
Title Incidence of Acute GVHD
Hide Description [Not Specified]
Time Frame Day +100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
Hide Arm/Group Description:
Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
1 0
4.Secondary Outcome
Title Infectious Complications in UCB Recipients.
Hide Description [Not Specified]
Time Frame Day +100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
Hide Arm/Group Description:
Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: participants
3 3
5.Secondary Outcome
Title Incidence of Chronic GVHD
Hide Description [Not Specified]
Time Frame After Day +100
Hide Outcome Measure Data
Hide Analysis Population Description
No subject receiving reduced intensity conditioning was evaluable for the event of chronic GVHD (0/3 subjects survived to day +100)
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
Hide Arm/Group Description:
Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
Overall Number of Participants Analyzed 2 0
Measure Type: Number
Unit of Measure: participants
1
6.Secondary Outcome
Title Compare Rates of Complications Between Patients Receiving Ablative vs. Non-myeloablative Conditioning Prior to UCB Transplantation
Hide Description Composite endpoint of GVH or infection. Too few events to compare between arms.
Time Frame +180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
Hide Arm/Group Description:

Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.

2/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity.

Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

1/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity.

Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: events
5 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Myeloablative Conditioning Reduced Intensity Conditioning
Hide Arm/Group Description

Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning

Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0.

Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning

Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.

All-Cause Mortality
Myeloablative Conditioning Reduced Intensity Conditioning
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Myeloablative Conditioning Reduced Intensity Conditioning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Febrile Neutropenia   3/3 (100.00%)  3 0/3 (0.00%)  0
Bone marrow hypocellular   0/3 (0.00%)  0 1/3 (33.33%)  1
Cardiac disorders     
Atrial fibrillation   0/3 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Typhlitis   1/3 (33.33%)  1 2/3 (66.67%)  2
Immune system disorders     
Gastrointestinal GVHD   2/3 (66.67%)  2 0/3 (0.00%)  0
Infections and infestations     
Sepsis   3/3 (100.00%)  3 2/3 (66.67%)  2
Lung Infection   2/3 (66.67%)  2 1/3 (33.33%)  1
Renal and urinary disorders     
Renal Failure   1/3 (33.33%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/3 (33.33%)  1 2/3 (66.67%)  2
Pulmonary Hemorrhage   1/3 (33.33%)  1 0/3 (0.00%)  0
Vascular disorders     
Thrombotic microangiopathy   0/3 (0.00%)  0 1/3 (33.33%)  1
Thromboembolic event   0/3 (0.00%)  0 1/3 (33.33%)  1
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 0%
Myeloablative Conditioning Reduced Intensity Conditioning
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/3 (0.00%)    
Psychiatric disorders     
Confusion  [1]  1/3 (33.33%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Nodules   1/3 (33.33%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Likely d/t severe medical illness, renal failure, and medication
Early termination leading to small numbers of subjects analyzed.
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: Andreas Klein, MD
Organization: Tufts Medical Center
Phone: 617-636-8884
EMail: aklein2@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00676806     History of Changes
Other Study ID Numbers: UCBT001
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: May 2, 2016
Results First Posted: July 22, 2016
Last Update Posted: June 1, 2017