Trial Outcomes & Findings for Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS (NCT NCT00025662)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

100 days after stem cell infusion

Results posted on

2016-10-28

Participant Flow

Recruitment dates: 9/21/01 to 11/14/05 Location: Quaternary referral institute

2 enrolled patients were not transplanted: one, because of donor refusal and the other because she was transplanted elsewhere

Participant milestones

Participant milestones
Measure	"RFT5-SMPT-dgA", an Anti-interleukin, Used in Transplants 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
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	"RFT5-SMPT-dgA", an Anti-interleukin, Used in Transplants 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
Overall Study Withdrawal by Subject	2
Overall Study Technical failure of manipulation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days after stem cell infusion

Population: all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria

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.

Outcome measures

Outcome measures
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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
Treatment-related Mortality	4.5 percentage of participants Interval 0.0 to 13.25

SECONDARY outcome

Timeframe: Dec 2011.

Population: all patients who received the selectively depleted transplant including one special exemption

Percent overall survival (actuarial) at analysis in Dec 2011.

Outcome measures

Outcome measures
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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 Survival	4.5 percentage of participants Interval 0.0 to 13.3

SECONDARY outcome

Timeframe: Dec 2011.

Population: All patients who received the selectively depleted transplant

Percent non relapse mortality (actuarial) at analysis in Dec 2011

Outcome measures

Outcome measures
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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
Cumulative Non Relapse Mortality	40.9 percentage of participants Interval 20.4 to 61.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 100 days from transplant

Population: All 22 subjects who received the selectively depleted transplant

Proportion of patients with acute GVHD, grade 1 to 4

Outcome measures

Outcome measures
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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
Acute GVHD (Any Grade) Using the CIBMTR Grading System.	54.5 percentage of participants Interval 33.7 to 75.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 100 days from transplant

Population: All 22 patients who received the selectively depleted transplant

Outcome measures

Outcome measures
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 Participants 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
Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.	18.2 percentage of participants

Adverse Events

RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants

Serious events: 22 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants n=22 participants at risk 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
Immune system disorders Non relapse deaths	100.0% 8/8 • Number of events 8 • The adverse event reporting was collected for 7 years.
Immune system disorders Relapse deaths	100.0% 10/10 • Number of events 10 • The adverse event reporting was collected for 7 years.
Immune system disorders Hospitalization	100.0% 4/4 • Number of events 4 • The adverse event reporting was collected for 7 years.

Other adverse events

Adverse event data not reported

Additional Information

A. John Barrett

NHLBI

Phone: 301-402-4170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place