Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01350245
First received: May 4, 2011
Last updated: October 7, 2014
Last verified: October 2014
Results First Received: October 7, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Biphenotypic Leukemia
Acute Lymphocytic Leukemia
Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Plasma Cell Neoplasms
Lymphoma
Hodgkin's Disease
Aplastic Anemia
Interventions: Radiation: Total Body Irradiation (TBI)
Biological: Donor Lymphocyte Infusion (DLI)
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil (MMF)
Drug: Tacrolimus
Device: Hematopoietic stem cell transplantation (HSCT)

  Participant Flow
  Hide 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
TJU 2 Step Regimen

All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.

Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).

Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.

Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days

Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)

Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)

Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do


Participant Flow:   Overall Study
    TJU 2 Step Regimen  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
TJU 2 Step Regimen

All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.

Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).

Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.

Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days

Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)

Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)

Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do


Baseline Measures
    TJU 2 Step Regimen  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean ± Standard Deviation
  45.2  ± 14.3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     1  
Gender  
[units: participants]
 
Female     8  
Male     20  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     22  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     24  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease-Free Survival (DFS)   [ Time Frame: 1 year post-transplant ]

2.  Primary:   Probability of Overall Survival at 15 Months Post-treatment   [ Time Frame: 15 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dolores Grosso, CRNP, DNP
Organization: Thomas Jefferson University
phone: 215-955-8874
e-mail: Dolores.Grosso@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01350245     History of Changes
Other Study ID Numbers: 10D.219, 2010-10
Study First Received: May 4, 2011
Results First Received: October 7, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board