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Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

This study has been terminated.
(Objectives not met.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01518153
First received: January 23, 2012
Last updated: February 18, 2016
Last verified: February 2016
Results First Received: January 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Myeloma
Myeloproliferative Diseases
Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: Alemtuzumab
Procedure: Stem Cell Infusion
Drug: Tacrolimus
Drug: Methotrexate
Drug: G-CSF
Procedure: Low Dose Donor T-Cells
Procedure: High Dose Donor T-Cells

  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
Recruitment Period: February 6, 2012 to February 27, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.

Reporting Groups
  Description
Stem Cell Infusion Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
Low Dose Donor T-Cells Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
High Dose Donor T-Cells Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.

Participant Flow for 2 periods

Period 1:   Stem Cell Transplant
    Stem Cell Infusion   Low Dose Donor T-Cells   High Dose Donor T-Cells
STARTED   16   0   0 
COMPLETED   7   0   0 
NOT COMPLETED   9   0   0 
Active graft-vs-host disease (GvHD)                5                0                0 
Death                2                0                0 
Secondary graft failure                1                0                0 
Adverse Event                1                0                0 

Period 2:   Donor Lymphocyte Infusion
    Stem Cell Infusion   Low Dose Donor T-Cells   High Dose Donor T-Cells
STARTED   0   3   4 
COMPLETED   0   1   3 
NOT COMPLETED   0   2   1 
Death                0                2                1 



  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
Stem Cell Transplant + Donor Lymphocyte Infusion Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.

Baseline Measures
   Stem Cell Transplant + Donor Lymphocyte Infusion 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Median (Full Range)
 58 
 (35 to 65) 
Gender 
[Units: Participants]
 
Female   5 
Male   11 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
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1.  Primary:   Success Rate   [ Time Frame: 100 days ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Every 3 months until day of death ]


  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
No text entered.


  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: Richard E. Champlin, MD/Chair, Stem Cell Transplantation
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-8750
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01518153     History of Changes
Other Study ID Numbers: 2011-1104
NCI-2012-00131 ( Registry Identifier: NCI CTRP )
Study First Received: January 23, 2012
Results First Received: January 22, 2016
Last Updated: February 18, 2016
Health Authority: United States: Institutional Review Board