Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps

This study has been terminated.
(Poor accrual)
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01350258
First received: May 4, 2011
Last updated: October 21, 2014
Last verified: October 2014
Results First Received: October 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hematologic Malignancies
Acute Leukemia
Myelodysplastic Syndromes (MDS) Other Than RA or RARS Subtypes.
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Myeloma
Chronic Myelogenous (or Myeloid) Leukemia (CML) Resistant to STI Therapy
Interventions: Drug: Fludarabine
Drug: Thiotepa
Radiation: Total Body Irradiation (TBI)
Biological: Donor Lymphocyte Infusion (DLI)
Drug: Melphalan
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
Transplant Treatment Group

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.


Participant Flow:   Overall Study
    Transplant Treatment Group  
STARTED     8  
COMPLETED     8  
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
Transplant Treatment Group

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.


Baseline Measures
    Transplant Treatment Group  
Number of Participants  
[units: participants]
  8  
Age  
[units: years]
Mean ± Standard Deviation
  60.43  ± 7.86  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     2  
Gender  
[units: participants]
 
Female     1  
Male     7  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     5  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     8  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase 1: Defined Dose of Melphalan (MEL)   [ Time Frame: 100 days post-transplant ]

2.  Primary:   Phase 2: Non-Relapse Mortality (NRM)   [ Time Frame: 100 days post-treatment ]

3.  Secondary:   Relapse Rate   [ Time Frame: At 1 and 3 years ]

4.  Secondary:   GVHD Incidence and Severity   [ Time Frame: At 1 and 3 years ]

5.  Secondary:   Engraftment Rate and Lymphoid Reconstitution   [ Time Frame: 100 days post-transplant ]

6.  Secondary:   Overall Survival   [ Time Frame: At 1 and 3 years ]


  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
Study was terminated due to extreme toxicity. The study was closed before any data could be collected.


  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: NCT01350258     History of Changes
Other Study ID Numbers: 10D.535, 2010-40
Study First Received: May 4, 2011
Results First Received: October 21, 2014
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board