Trial record 1 of 1 for:
00534118
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
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ClinicalTrials.gov Identifier: NCT00534118 |
Recruitment Status :
Completed
First Posted : September 24, 2007
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
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Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Intervention |
Biological: donor lymphocytes |
Enrollment | 39 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Multiple DLI | Single DLI |
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Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions | accruals where the patient received only one donor lymphocyte infusion |
Period Title: Overall Study | ||
Started | 17 | 22 |
Completed | 17 | 22 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Multiple DLI | Single DLI | Total | |
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Accruals where the patient received 2-4 donor lymphocyte infusions Arm includes total number of infusions | Accruals where the patient received only one donor lymphocyte infusion | Total of all reporting groups | |
Overall Number of Baseline Participants | 15 | 12 | 27 | |
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Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. >8 weeks between infusions per the protocol). DLIs which were given <8 weeks apart counted as one accrual.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
<=18 years |
1 6.7%
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1 8.3%
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2 7.4%
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Between 18 and 65 years |
12 80.0%
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9 75.0%
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21 77.8%
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>=65 years |
2 13.3%
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2 16.7%
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4 14.8%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
45
(16 to 66)
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53.5
(9 to 68)
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51
(9 to 68)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
Female |
5 33.3%
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2 16.7%
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7 25.9%
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Male |
10 66.7%
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10 83.3%
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20 74.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
15 100.0%
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12 100.0%
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27 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
American Indian or Alaska Native |
1 6.7%
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0 0.0%
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1 3.7%
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Asian |
1 6.7%
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0 0.0%
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1 3.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
13 86.7%
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12 100.0%
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25 92.6%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 15 participants | 12 participants | 27 participants |
15 | 12 | 27 | ||
Disease
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 12 participants | 27 participants | |
Acute Myeloid Leukemia |
8 53.3%
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9 75.0%
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17 63.0%
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Myelodysplastic Syndrome |
2 13.3%
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0 0.0%
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2 7.4%
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Non Hodgkin Leukemia |
2 13.3%
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1 8.3%
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3 11.1%
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Acute Lymphoblastic Leukemia |
1 6.7%
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0 0.0%
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1 3.7%
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Chronic Myeloid Leukemia |
1 6.7%
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1 8.3%
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2 7.4%
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Hodgkin Lymphoma |
1 6.7%
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0 0.0%
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1 3.7%
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Prolymphocytic Leukemia |
0 0.0%
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1 8.3%
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1 3.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Theresa Hahn |
Organization: | Roswell Park Cancer Institute |
Phone: | 716-845-2300 |
EMail: | theresa.hahn@roswellpark.org |
Responsible Party: | Roswell Park Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00534118 |
Other Study ID Numbers: |
CDR0000564827 RPCI-I-00703 |
First Submitted: | September 20, 2007 |
First Posted: | September 24, 2007 |
Results First Submitted: | July 29, 2020 |
Results First Posted: | August 26, 2020 |
Last Update Posted: | August 26, 2020 |