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Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS

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ClinicalTrials.gov Identifier: NCT00025662
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 13, 2012
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Graft vs Host Disease
Myelodysplastic Syndromes
Leukemia
Leukemia, Myeloid
Leukemia, Myelomonocytic, Chronic
Leukemia, Lymphocytic
Lymphoma
Lymphoma, Mantle-cell
Lymphoma, Non-Hodgkin
Hodgkin Disease
Interventions Drug: RFT5-SMPT-dgA
Drug: Isolex system
Enrollment 23
Recruitment Details Recruitment dates: 9/21/01 to 11/14/05 Location: Quaternary referral institute
Pre-assignment Details 2 enrolled patients were not transplanted: one, because of donor refusal and the other because she was transplanted elsewhere
Arm/Group Title "RFT5-SMPT-dgA", an Anti-interleukin, Used in Transplants
Hide Arm/Group Description Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing "RFT5-SMPT-dgA", a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Period Title: Overall Study
Started 25
Completed 22 [1]
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Technical failure of manipulation             1
[1]
One patient who received a transplant did not meet eligibility and was a special exemption.
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  59.1%
>=65 years
9
  40.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
63  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
9
  40.9%
Male
13
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Treatment-related Mortality
Hide Description

Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects.

This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011.

Time Frame 100 days after stem cell infusion
Hide Outcome Measure Data
Hide Analysis Population Description
all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description:
Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.5
(0 to 13.25)
2.Secondary Outcome
Title Overall Survival
Hide Description Percent overall survival (actuarial) at analysis in Dec 2011.
Time Frame Dec 2011.
Hide Outcome Measure Data
Hide Analysis Population Description
all patients who received the selectively depleted transplant including one special exemption
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description:
Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.5
(0 to 13.3)
3.Secondary Outcome
Title Cumulative Non Relapse Mortality
Hide Description Percent non relapse mortality (actuarial) at analysis in Dec 2011
Time Frame Dec 2011.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received the selectively depleted transplant
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description:
Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.9
(20.4 to 61.5)
4.Other Pre-specified Outcome
Title Acute GVHD (Any Grade) Using the CIBMTR Grading System.
Hide Description Proportion of patients with acute GVHD, grade 1 to 4
Time Frame 100 days from transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All 22 subjects who received the selectively depleted transplant
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description:
Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.5
(33.7 to 75.4)
5.Other Pre-specified Outcome
Title Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.
Hide Description [Not Specified]
Time Frame 100 days from transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All 22 patients who received the selectively depleted transplant
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description:
Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
18.2
Time Frame The adverse event reporting was collected for 7 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Hide Arm/Group Description Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
All-Cause Mortality
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Affected / at Risk (%) # Events
Total   22/22 (100.00%)    
Immune system disorders   
Non relapse deaths *  8/8 (100.00%)  8
Relapse deaths *  10/10 (100.00%)  10
Hospitalization *  4/4 (100.00%)  4
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A. John Barrett
Organization: NHLBI
Phone: 301-402-4170
EMail: barrettjj@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00025662    
Obsolete Identifiers: NCT00016484
Other Study ID Numbers: 010162
01-H-0162 ( Other Identifier: NIH )
First Submitted: October 11, 2001
First Posted: January 27, 2003
Results First Submitted: April 20, 2011
Results First Posted: January 13, 2012
Last Update Posted: October 28, 2016