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Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00295880
Recruitment Status : Terminated (Time to engraftment would not be improved compared to historical controls.)
First Posted : February 24, 2006
Results First Posted : September 3, 2009
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myeloproliferative Disorders
Leukemia
Lymphoma
Myelodysplastic Syndromes
Intervention Procedure: umbilical cord blood transplantation
Enrollment 12
Recruitment Details Patients are recruited from within the Department of Blood and Marrow Transplant Program. (Patients will be co-enrolled on study MT2005-10 (NCT00309842). Eligibility for this study are identical to MT2005-10.)
Pre-assignment Details  
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
IBMI unit could not be volume reduced             1
Unit randomization did not occur             1
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
34  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Median Number of Days to Neutrophil Engraftment
Hide Description Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.
Time Frame Daily through Day 60 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Days
21
(17 to 49)
2.Secondary Outcome
Title Number of Patients Achieving Neutrophil Recovery
Hide Description Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed treatment.
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
9
3.Secondary Outcome
Title Number of Patients With Evidence of Engraftment.
Hide Description Number of patients who received both cord blood units and achieved sustained donor engraftment
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was not evaluable due to graft failure
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
2
4.Secondary Outcome
Title Number of Patients With Acute Graft-versus-host Disease (GVHD)
Hide Description Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.
Time Frame 100 days post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients were not graded for acute GVHD due to graft failure.
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
7
5.Secondary Outcome
Title Number of Patients With Transplant-related Mortality (TRM)
Hide Description Number of patients who were deceased at days 100 and 180 from any cause other than relapse.
Time Frame Day 100 and Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
5
6.Secondary Outcome
Title Number of Patients Surviving at Day 100 and 1 Year.
Hide Description Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.
Time Frame Day 100 and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
5
7.Secondary Outcome
Title Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)
Hide Description Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.
Time Frame 100 days post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients were not yet graded for acute gvhd
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
2
8.Secondary Outcome
Title Number of Patients With Chronic Graft-versus-host Disease (GVHD).
Hide Description Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Only 7 patients were at risk for chronic GVHD
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description:
Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Umbilical Cord Blood Transplant Patients
Hide Arm/Group Description Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
All-Cause Mortality
Umbilical Cord Blood Transplant Patients
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Umbilical Cord Blood Transplant Patients
Affected / at Risk (%) # Events
Total   5/12 (41.67%)    
Blood and lymphatic system disorders   
graft failure   1/12 (8.33%)  1
Acute GVHD Grade 3   2/12 (16.67%)  2
General disorders   
Death *  5/12 (41.67%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Umbilical Cord Blood Transplant Patients
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
This study was terminated early based on interim statistical analysis that indicated time to engraftment will not be improved compared to historical controls. While safe, lack of faster marrow recovery supports early discontinuation.
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: John E. Wagner, M.D.
Organization: Masonic Cancer Center, University of Minnesota Blood and Marrow Transplant Program
Phone: 612-626-2961
EMail: wagne002@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00295880    
Other Study ID Numbers: 2004LS072
UMN-MT2004-26 ( Other Identifier: Blood and Bone Marrow Transplant Program )
UMN-0412M65789 ( Other Identifier: IRB at University of Minnesota )
First Submitted: February 23, 2006
First Posted: February 24, 2006
Results First Submitted: March 25, 2009
Results First Posted: September 3, 2009
Last Update Posted: December 28, 2017