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Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT01231412
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : December 4, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brenda Sandmaier, Fred Hutchinson Cancer Research Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Aggressive Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Hematopoietic and Lymphoid Cell Neoplasm
Indolent Non-Hodgkin Lymphoma
Mantle Cell Lymphoma
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Prolymphocytic Leukemia
Recurrent Chronic Lymphocytic Leukemia
Recurrent Plasma Cell Myeloma
Refractory Chronic Lymphocytic Leukemia
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Hodgkin Lymphoma
Small Lymphocytic Lymphoma
T-Cell Chronic Lymphocytic Leukemia
Waldenstrom Macroglobulinemia
Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Sirolimus
Radiation: Total-Body Irradiation

  Participant Flow

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
Arm I (MMF and CSP)

Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT

Cyclosporine: Given PO or IV

Fludarabine Phosphate: Given IV

Mycophenolate Mofetil: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT

Total-Body Irradiation: Undergo TBI

Arm II (MMF, CSP, and Sirolimus)

Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT

Cyclosporine: Given PO or IV

Fludarabine Phosphate: Given IV

Mycophenolate Mofetil: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT

Sirolimus: Given PO

Total-Body Irradiation: Undergo TBI

Arm 0 (CSP and Sirolimus) Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011

Participant Flow:   Overall Study
    Arm I (MMF and CSP)   Arm II (MMF, CSP, and Sirolimus)   Arm 0 (CSP and Sirolimus)
STARTED   77   91   6 
COMPLETED   77   90   6 
NOT COMPLETED   0   1   0 



  Baseline Characteristics

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 (MMF and CSP)

Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI.

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT

Cyclosporine: Given PO or IV

Fludarabine Phosphate: Given IV

Mycophenolate Mofetil: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT

Total-Body Irradiation: Undergo TBI

Arm II (MMF, CSP, and Sirolimus)

Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI.

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT

Cyclosporine: Given PO or IV

Fludarabine Phosphate: Given IV

Mycophenolate Mofetil: Given PO

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT

Sirolimus: Given PO

Total-Body Irradiation: Undergo TBI

Arm 0 (CSP and Sirolimus) Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
Total Total of all reporting groups

Baseline Measures
   Arm I (MMF and CSP)   Arm II (MMF, CSP, and Sirolimus)   Arm 0 (CSP and Sirolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   91   6   174 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      52  67.5%      50  54.9%      4  66.7%      106  60.9% 
>=65 years      25  32.5%      41  45.1%      2  33.3%      68  39.1% 
Age 
[Units: Years]
Median (Full Range)
 61.94 
 (18.2 to 77.09) 
 63.75 
 (41.02 to 79) 
 59.515 
 (36.47 to 67.83) 
 62.655 
 (18.2 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      27  35.1%      28  30.8%      2  33.3%      57  32.8% 
Male      50  64.9%      63  69.2%      4  66.7%      117  67.2% 
Region of Enrollment 
[Units: Participants]
       
United States   65   78   6   149 
Denmark   10   12   0   22 
Germany   2   1   0   3 


  Outcome Measures

1.  Primary:   Incidences of Acute Grade II-IV GVHD, Exclusive of GVHD That Occurs as a Result of Alterations to Immunosuppressive Therapy in Response to Relapse or Progression   [ Time Frame: At day 100 post-transplant ]

2.  Secondary:   Incidences of Chronic Extensive GVHD   [ Time Frame: Up to 1 year ]

3.  Secondary:   Incidences of Grade III-IV Acute GVHD   [ Time Frame: Up to 100 days ]

4.  Secondary:   Incidences of Non-relapse Mortality   [ Time Frame: Up to 1 year ]

5.  Secondary:   Overall Survival   [ Time Frame: Up to 1 year ]

6.  Secondary:   Number of Participants With Relapse/Progression   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: NCT01231412     History of Changes
Other Study ID Numbers: 2448.00
NCI-2010-02035 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2448.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA018029 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: October 28, 2010
First Posted: November 1, 2010
Results First Submitted: November 1, 2017
Results First Posted: December 4, 2017
Last Update Posted: March 13, 2018