Trial Outcomes & Findings for Anti-Tac(Fv)-PE38 (LMB-2) to Treat Cutaneous T-Cell Lymphomas (NCT NCT00080535)
NCT ID: NCT00080535
Last Updated: 2018-01-29
Results Overview
Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.
Results posted on
2018-01-29
Participant Flow
Participant milestones
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Cutaneous T-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
n=10 Participants
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
55.85 years
STANDARD_DEVIATION 17.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.
Outcome measures
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
n=10 Participants
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Response Rate
Complete Response
|
0 Participants
|
|
Response Rate
Complete Response unconfirmed
|
0 Participants
|
|
Response Rate
Partial Response
|
1 Participants
|
|
Response Rate
Progressive Disease
|
1 Participants
|
|
Response Rate
Stable Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
n=10 Participants
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
Adverse Events
LMB-2 for Cutaneous Tcell Lymphoma
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
n=10 participants at risk
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bone (osteomyelitis)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
Other adverse events
| Measure |
LMB-2 for Cutaneous Tcell Lymphoma
n=10 participants at risk
30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline auidgram and not enrolled in a monitoring program)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
haptoglobin
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
5/10 • Number of events 9 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
20.0%
2/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
40.0%
4/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
10.0%
1/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Platelets
|
30.0%
3/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
fibrinogen
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
70.0%
7/10 • Number of events 9 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Sweating (diaphoresis)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Weight gain
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Weight loss
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
General disorders
Hemorrhage/Bleeding - other (Specify)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Blood and lymphatic system disorders
Edema: limb
|
60.0%
6/10 • Number of events 8 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
40.0%
4/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
60.0%
6/10 • Number of events 9 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
60.0%
6/10 • Number of events 15 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
40.0%
4/10 • Number of events 10 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
2/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
30.0%
3/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
70.0%
7/10 • Number of events 9 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Proteinuria
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
30.0%
3/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Nervous system disorders
Confusion
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Nervous system disorders
Neurology-Other (Specify, neurology: dizziness)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Nervous system disorders
Pain::Head/headache
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
40.0%
4/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
4/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion/non-malignant
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Vascular disorders
Acute vascular leak syndrome
|
50.0%
5/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 years, 8 months and 17 days.
|
Additional Information
Robert J. Kreitman, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-6947
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place