Post Transplant Donor Lymphocyte Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167180
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 11, 2017
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia, Myeloid, Chronic
Multiple Myeloma
Myelodysplastic Syndrome
Leukemia, Lymphocytic, Acute
Leukemia, Lymphocytic, Chronic
Interventions: Procedure: Donor Lymphocyte Infusion
Drug: Induction Chemotherapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the recruitment period of the study, the donor lymphocyte infusion (DLI) was reduced from 1.0 x 10^8 CD3+ T-cells/kg to 0.5 x 10^8 CD3+ T-cells/kg due to an excess rate and intensity of graft vs. host disease.

Reporting Groups
Chronic Myelogenous Leukemia (CML)

Patients who have failed or refused Gleevec (TM) therapy and will receive Donor Lymphocyte Infusion.

Donor Lymphocyte Infusion: donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg

Non-CML or CML Failing Donor Lymphocyte Infusion

Patients with non-CML or CML who have failed DLI and will receive Induction Chemotherapy + DLI.

Induction Chemotherapy + DLI: Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV Donor Lymphocyte Infusion (DLI)

Participant Flow:   Overall Study
    Chronic Myelogenous Leukemia (CML)   Non-CML or CML Failing Donor Lymphocyte Infusion
STARTED   0   57 
COMPLETED   0   57 

  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
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg No text entered.
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg No text entered.
Total Total of all reporting groups

Baseline Measures
   DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg   DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   42   57 
[Units: Participants]
Count of Participants
<=18 years      1   6.7%      2   4.8%      3   5.3% 
Between 18 and 65 years      14  93.3%      36  85.7%      50  87.7% 
>=65 years      0   0.0%      4   9.5%      4   7.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      7  46.7%      18  42.9%      25  43.9% 
Male      8  53.3%      24  57.1%      32  56.1% 

  Outcome Measures

1.  Primary:   Number of Patients Alive   [ Time Frame: 1 Year ]

2.  Secondary:   Number of Patients Alive Without Disease   [ Time Frame: 1 Year ]

3.  Secondary:   Number of Participants With Complete Remission   [ Time Frame: one year ]

4.  Secondary:   Number of Patients With Acute Graft-Versus-Host Disease   [ Time Frame: Day 100 ]

5.  Secondary:   Number of Patients With Bone Marrow Aplasia   [ Time Frame: Day 100 ]

  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Jeffrey Miller
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-625-7409

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00167180     History of Changes
Obsolete Identifiers: NCT00303693
Other Study ID Numbers: 2004LS006
MT2003-15 ( Other Identifier: Blood and Marrow Transplantation Program )
0401M55207 ( Other Identifier: IRB, University of Minnesota )
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: April 28, 2017
Results First Posted: July 11, 2017
Last Update Posted: December 5, 2017