Trial Outcomes & Findings for Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma (NCT NCT00896493)
NCT ID: NCT00896493
Last Updated: 2023-05-11
Results Overview
Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
180 days
Results posted on
2023-05-11
Participant Flow
Participant milestones
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
Total lymphoid irradiation (TLI) is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
Completed Assigned Treatment
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
Total lymphoid irradiation (TLI) is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
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|---|---|
|
Overall Study
Early disease relapse
|
3
|
Baseline Characteristics
Participants who completed assigned treatment
Baseline characteristics by cohort
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=38 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
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|---|---|
|
Age, Continuous
|
62 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
1 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=38 Participants
|
|
Diagnosis
Mycosis fungoides
|
20 Participants
n=38 Participants
|
|
Diagnosis
Sezary Syndrome
|
18 Participants
n=38 Participants
|
|
Retro-CLIPI
High risk
|
18 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Retro-CLIPI
Intermediate risk
|
13 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Retro-CLIPI
Low risk
|
4 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Time from diagnosis to allogeneic HCT
|
40 months
n=35 Participants • Participants who completed assigned treatment
|
|
Active disease at the time of conditioning
Skin
|
35 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Active disease at the time of conditioning
Blood
|
12 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Active disease at the time of conditioning
Lymph node
|
22 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Active disease at the time of conditioning
Visceral (site: bone marrow)
|
4 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Active disease at the time of conditioning
Visceral (site: tonsil)
|
1 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Donor
Sibling
|
13 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Donor
Unrelated - matched
|
15 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Donor
Unrelated - unmatched
|
7 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Donor-recipient cytomegalovirus (CMV) status
Donor and/or recipient seropositive
|
27 Participants
n=35 Participants • Participants who completed assigned treatment
|
|
Donor-recipient cytomegalovirus (CMV) status
Donor and recipient seronegative
|
8 Participants
n=35 Participants • Participants who completed assigned treatment
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Participants who completed assigned treatment
Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Progression-Free Survival (PFS) at 180 Days
|
73 percentage of participants
Interval 55.0 to 85.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed assigned treatment
Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria.
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Any Grade
|
9 Participants
|
|
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Grade II-IV
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed assigned treatment
Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria.
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Number of Participants With Chronic Graft-versus-host Disease (GVHD)
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed assigned treatment
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Overall Survival (OS)
|
68 percentage of participants
Interval 50.0 to 81.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants who completed assigned treatment
Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause (Kaplan-Meier estimate).
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Overall Survival (OS)
|
56 percentage of participants
Interval 38.0 to 71.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants who completed assigned treatment
Total count of non-relapsed mortality and mortality from relapsed disease.
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Mortality
Non-relaped, treatment related
|
5 Participants
|
|
Mortality
Non-relaped, not treatment related
|
1 Participants
|
|
Mortality
Disease relapse
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants who completed assigned treatment
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Treatment Related Mortality
Hepatitis B
|
1 Participants
|
|
Treatment Related Mortality
Acute GVHD
|
1 Participants
|
|
Treatment Related Mortality
Chronic GVHD
|
1 Participants
|
|
Treatment Related Mortality
Secondary malignancy
|
1 Participants
|
|
Treatment Related Mortality
Hemorrhage secondary to anticoagulation
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who completed assigned treatment
Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Event Free Survival (EFS)
|
40 percentage of participants
Interval 24.0 to 56.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants who completed assigned treatment
Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause (Kaplan-Meier estimate).
Outcome measures
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=35 Participants
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Event Free Survival (EFS)
|
26 percentage of participants
Interval 13.0 to 41.0
|
Adverse Events
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
Serious events: 7 serious events
Other events: 20 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=38 participants at risk
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
2.6%
1/38 • Up to 5 years
|
|
Hepatobiliary disorders
Acute Viral Hepatitis
|
2.6%
1/38 • Up to 5 years
|
|
Hepatobiliary disorders
Liver Failure
|
2.6%
1/38 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Up to 5 years
|
|
Gastrointestinal disorders
GI Bleeding
|
2.6%
1/38 • Up to 5 years
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
2.6%
1/38 • Up to 5 years
|
|
General disorders
Multi-organ failure
|
2.6%
1/38 • Up to 5 years
|
|
Gastrointestinal disorders
Acute appendicitis
|
2.6%
1/38 • Up to 5 years
|
|
General disorders
Hemorrhage
|
2.6%
1/38 • Up to 5 years
|
Other adverse events
| Measure |
Total Lymphoid Irradiation & Anti-thymocyte Immunoglobulin
n=38 participants at risk
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
|
|---|---|
|
Injury, poisoning and procedural complications
Serum sickness
|
7.9%
3/38 • Up to 5 years
|
|
General disorders
Disease Relapse
|
52.6%
20/38 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
5.3%
2/38 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
42.1%
16/38 • Up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.8%
6/38 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Up to 5 years
|
|
Infections and infestations
Neutropenic fever
|
7.9%
3/38 • Up to 5 years
|
|
Infections and infestations
Infection, non-specified
|
10.5%
4/38 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
2.6%
1/38 • Up to 5 years
|
|
Infections and infestations
Post transplant lymphoproliferative disorder (PTLD)
|
5.3%
2/38 • Up to 5 years
|
|
Infections and infestations
CMV viremia
|
44.7%
17/38 • Up to 5 years
|
|
Infections and infestations
EBV viremia
|
21.1%
8/38 • Up to 5 years
|
Additional Information
Wen-Kai Weng, Associate Professor of Medicine
Stanford University Medical Center
Phone: 650-723-7689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place