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Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

This study has been terminated.
(A new protocol was developed to replace this protocol in 2008, with removal of ATG and extension of MMF duration.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719849
First Posted: July 22, 2008
Last Update Posted: June 14, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Colleen Delaney, Fred Hutchinson Cancer Research Center
Results First Submitted: April 5, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions: Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: umbilical cord blood transplantation
Radiation: total body irradiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Cyclophosphamide/Fludarabine/TBI

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Cyclophosphamide/Fludarabine/TBI/ATG

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil


Participant Flow:   Overall Study
    Cyclophosphamide/Fludarabine/TBI   Cyclophosphamide/Fludarabine/TBI/ATG
STARTED   4   9 
COMPLETED   4   8 
NOT COMPLETED   0   1 
Death                0                1 



  Baseline Characteristics
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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
Cyclophosphamide/Fludarabine/TBI

Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day -1

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Cyclophosphamide/Fludarabine/TBI/ATG

Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.

  • Cyclophosphamide 50 mg/Kg Day –6
  • Fludarabine 40mg/m2 Days –6 to –2
  • TBI 200 cGy Day –1
  • Equine ATG 30mg/Kg Days –6 to -4

Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil

Total Total of all reporting groups

Baseline Measures
   Cyclophosphamide/Fludarabine/TBI   Cyclophosphamide/Fludarabine/TBI/ATG   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   9   13 
Age 
[Units: Years]
Mean (Full Range)
 52.5 
 (24 to 67) 
 55.1 
 (37 to 68) 
 53.6 
 (24 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      4  44.4%      5  38.5% 
Male      3  75.0%      5  55.6%      8  61.5% 
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      0   0.0%      2  22.2%      2  15.4% 
White      4 100.0%      7  77.8%      11  84.6% 
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% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   4   9   13 
Disease Diagnosis 
[Units: Participants]
Count of Participants
     
AML (Acute Myeloid Leukemia)      4 100.0%      5  55.6%      9  69.2% 
CML (Chronic Myeloid Leukemia)      0   0.0%      1  11.1%      1   7.7% 
NHL (Non-Hodgkin's Lymphoma)      0   0.0%      1  11.1%      1   7.7% 
MDS (Myelodysplastic Syndromes)      0   0.0%      2  22.2%      2  15.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Probability of Survival at 1 Year   [ Time Frame: 1 year post transplant ]

2.  Secondary:   Probability of Survival at 2 Years   [ Time Frame: 2 years post transplant ]

3.  Secondary:   Incidence of Non-relapse Mortality at 6 Months   [ Time Frame: 6 months post transplant ]

4.  Secondary:   Chimerism   [ Time Frame: 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant ]

5.  Secondary:   Incidence of Neutrophil Engraftment at Day 42   [ Time Frame: Day 42 post transplant ]

6.  Secondary:   Incidence of Platelet Engraftment at 6 Months   [ Time Frame: 6 months post transplant ]

7.  Secondary:   Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100   [ Time Frame: Day 100 post transplant ]

8.  Secondary:   Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100   [ Time Frame: Day 100 post transplant ]

9.  Secondary:   Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year   [ Time Frame: 1 year post transplant ]

10.  Secondary:   Incidence of Clinically Significant Infections at 6 Months   [ Time Frame: 6 months post transplant ]

11.  Secondary:   Incidence of Clinically Significant Infections at 1 Year   [ Time Frame: 1 year post transplant ]

12.  Secondary:   Incidence of Clinically Significant Infections at 2 Years   [ Time Frame: 2 years post transplant ]

13.  Secondary:   Probability of Progression-free Survival at 1 Year   [ Time Frame: 1 year post transplant ]

14.  Secondary:   Probability of Progression-free Survival at 2 Years   [ Time Frame: 2 years post transplant ]

15.  Secondary:   Incidence of Relapse at 1 Year   [ Time Frame: 1 year post transplant ]

16.  Secondary:   Incidence of Relapse at 2 Years   [ Time Frame: 2 years post transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Colleen Delaney
Organization: Fred Hutchinson Cancer Research Center
phone: 2066671385
e-mail: cdelaney@fredhutch.org



Responsible Party: Colleen Delaney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00719849     History of Changes
Other Study ID Numbers: 2012.00
FHCRC-2012.00 ( Other Identifier: FHCRC Protocol Number )
CDR0000597623 ( Registry Identifier: PDQ )
T32CA009515 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2008
First Posted: July 22, 2008
Results First Submitted: April 5, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017