Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Bart Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00322101
First received: May 2, 2006
Last updated: August 21, 2013
Last verified: August 2013
Results First Received: April 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
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(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Childhood Acute Myeloid Leukemia in Remission
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Myelodysplastic Syndrome With Isolated Del(5q)
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Interventions: Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: cyclophosphamide
Drug: mycophenolate mofetil
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Genetic: cytogenetic analysis
Other: flow cytometry
Genetic: fluorescence in situ hybridization
Other: pharmacological study
Genetic: polymorphism analysis
Drug: tacrolimus
Drug: methotrexate

  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
Patients were recruited from medical clinics while being evaluated for stem cell transplantation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
Arm I (Nonmyeloablative Regimen)

CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.

Arm II (Myeloablative Regimen)

CONDITIONING: Patients are assigned to 1 of 2 treatment groups.

Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.

Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.

TRANSPLANTATION: Patients undergo PBSC infusion on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.


Participant Flow:   Overall Study
    Arm I (Nonmyeloablative Regimen)     Arm II (Myeloablative Regimen)  
STARTED     14     11  
COMPLETED     14     11  
NOT COMPLETED     0     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
Arm I (Nonmyeloablative Regimen)

CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.

Arm II (Myeloablative Regimen)

CONDITIONING: Patients are assigned to 1 of 2 treatment groups.

Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.

Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.

TRANSPLANTATION: Patients undergo PBSC infusion on day 0.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Total Total of all reporting groups

Baseline Measures
    Arm I (Nonmyeloablative Regimen)     Arm II (Myeloablative Regimen)     Total  
Number of Participants  
[units: participants]
  14     11     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     11     25  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.47  ± 9.49     52.82  ± 5.78     52.2  ± 7.94  
Gender  
[units: participants]
     
Female     8     3     11  
Male     6     8     14  
Region of Enrollment  
[units: participants]
     
United States     8     7     15  
Germany     6     4     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: At 2 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: After stem cell infusion to date of last follow up. ]

3.  Secondary:   Non-relapse Mortality   [ Time Frame: At 100 days ]

4.  Secondary:   Donor Cell Engraftment   [ Time Frame: After stem cell infusion to day 28 ]

5.  Secondary:   Incidence of Disease Progression/Relapse   [ Time Frame: After stem cell infusion to date of last follow up. ]

6.  Secondary:   Incidence and Severity of Acute and Chronic Graft-vs-host Disease   [ Time Frame: After transplantation ]


  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: Bart Lee Scott
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-1990
e-mail: bscott@fhcrc.org


No publications provided


Responsible Party: Bart Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00322101     History of Changes
Other Study ID Numbers: 1992.00, NCI-2010-00737, P01CA078902, K23HL084054, P01CA018029, P01HL036444
Study First Received: May 2, 2006
Results First Received: April 4, 2013
Last Updated: August 21, 2013
Health Authority: United States: Federal Government