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Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00045435
First Posted: January 27, 2003
Last Update Posted: May 19, 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):
Brenda Sandmaier, Fred Hutchinson Cancer Research Center
Results First Submitted: January 25, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Interventions: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Drug: fludarabine phosphate
Radiation: total-body irradiation
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation

  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
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Reporting Groups
  Description
Treatment (Nonmyeloablative Donor PBSC Transplant)

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.

Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant

Fludarabine phosphate: Given IV

Total-body irradiation: Undergo total-body irradiation

Cyclosporine: Given PO

Mycophenolate mofetil: Given PO

Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant


Participant Flow:   Overall Study
    Treatment (Nonmyeloablative Donor PBSC Transplant)
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 



  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
Treatment (Nonmyeloablative Donor PBSC Transplant)

Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.

Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant

Fludarabine phosphate: Given IV

Total-body irradiation: Undergo total-body irradiation

Cyclosporine: Given PO

Mycophenolate mofetil: Given PO

Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant


Baseline Measures
   Treatment (Nonmyeloablative Donor PBSC Transplant) 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10  58.8% 
>=65 years      7  41.2% 
Age 
[Units: Years]
Median (Full Range)
 64.8 
 (56 to 72.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  23.5% 
Male      13  76.5% 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures
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1.  Primary:   Disease-free Survival-incidence of Survival Without Relapse   [ Time Frame: By 1 year after transplant ]

2.  Primary:   Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death   [ Time Frame: 200 days after transplant ]

3.  Secondary:   Overall Survival   [ Time Frame: By 1 year after transplant ]

4.  Secondary:   Incidence of Relapse   [ Time Frame: By 1 year after transplant ]

5.  Secondary:   Incidence of Rejection   [ Time Frame: By 1 year after transplant ]

6.  Secondary:   Incidence of Acute and Chronic GVHD   [ Time Frame: aGVHD: 100 days after transplant; cGVHD: 1 Year after 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. Brenda M. Sandmaier
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-4961
e-mail: bsandmai@fhcrc.org



Responsible Party: Brenda Sandmaier, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00045435     History of Changes
Other Study ID Numbers: 1654.00
NCI-2011-01307 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 6, 2002
First Posted: January 27, 2003
Results First Submitted: January 25, 2017
Results First Posted: March 16, 2017
Last Update Posted: May 19, 2017