Trial Outcomes & Findings for Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia (NCT NCT00077922)
NCT ID: NCT00077922
Last Updated: 2018-01-23
Results Overview
Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to \<1.0cm of 1-1.5cm at baseline, or \<1.5cm if \>1.5cm at baseline. Partial response is \>=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is \>=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be \>=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
LMB-2 in Chronic Lymphocytic Leukemia
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
LMB-2 in Chronic Lymphocytic Leukemia
n=15 Participants
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
61.36 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 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
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to \<1.0cm of 1-1.5cm at baseline, or \<1.5cm if \>1.5cm at baseline. Partial response is \>=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is \>=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be \>=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.
Outcome measures
| Measure |
LMB-2 in Chronic Lymphocytic Leukemia
n=15 Participants
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Response Rate
Complete Response
|
0 Participants
|
|
Response Rate
Partial Response
|
1 Participants
|
|
Response Rate
Progressive Disease
|
3 Participants
|
|
Response Rate
Stable Disease
|
11 Participants
|
SECONDARY outcome
Timeframe: 54 monthsHere 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 in Chronic Lymphocytic Leukemia
n=15 Participants
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Number of Participants With Adverse Events
|
15 Participants
|
Adverse Events
LMB-2 in Chronic Lymphocytic Leukemia
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LMB-2 in Chronic Lymphocytic Leukemia
n=15 participants at risk
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Blood and lymphatic system disorders
Platelets
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Infections and infestations
Infection
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Confusion
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Eye disorders
Ocular/Visual-Other (Specify, blindness r/t CVA)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Renal and urinary disorders
Obstruction, GU: Ureter
|
6.7%
1/15 • Number of events 1 • 54 months
|
Other adverse events
| Measure |
LMB-2 in Chronic Lymphocytic Leukemia
n=15 participants at risk
40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Blood and lymphatic system disorders
haptoglobin
|
13.3%
2/15 • Number of events 5 • 54 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.0%
9/15 • Number of events 71 • 54 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.7%
1/15 • Number of events 4 • 54 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AG)
|
53.3%
8/15 • Number of events 30 • 54 months
|
|
Blood and lymphatic system disorders
Platelets
|
46.7%
7/15 • Number of events 48 • 54 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Cardiac disorders
Hypotension
|
20.0%
3/15 • Number of events 4 • 54 months
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Blood and lymphatic system disorders
fibrinogen
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
46.7%
7/15 • Number of events 13 • 54 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
73.3%
11/15 • Number of events 23 • 54 months
|
|
General disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
General disorders
Rigors/chills
|
20.0%
3/15 • Number of events 4 • 54 months
|
|
General disorders
Sweating (diaphoresis)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
General disorders
Weight gain
|
60.0%
9/15 • Number of events 15 • 54 months
|
|
General disorders
Weight loss
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
33.3%
5/15 • Number of events 5 • 54 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Anorexia
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 12 • 54 months
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
6.7%
1/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Number of events 6 • 54 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Bladder
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
40.0%
6/15 • Number of events 8 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Lung
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Infections and infestations
Febrile neutropenia
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)
|
20.0%
3/15 • Number of events 7 • 54 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Blood and lymphatic system disorders
Edema: limb
|
66.7%
10/15 • Number of events 19 • 54 months
|
|
Blood and lymphatic system disorders
Edema::head and neck
|
40.0%
6/15 • Number of events 14 • 54 months
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
26.7%
4/15 • Number of events 10 • 54 months
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
73.3%
11/15 • Number of events 49 • 54 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
93.3%
14/15 • Number of events 72 • 54 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
40.0%
6/15 • Number of events 19 • 54 months
|
|
Metabolism and nutrition disorders
Amylase
|
20.0%
3/15 • Number of events 4 • 54 months
|
|
Metabolism and nutrition disorders
Bicarbonate, serum low
|
13.3%
2/15 • Number of events 4 • 54 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
33.3%
5/15 • Number of events 13 • 54 months
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
20.0%
3/15 • Number of events 7 • 54 months
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
3/15 • Number of events 11 • 54 months
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
13.3%
2/15 • Number of events 4 • 54 months
|
|
Metabolism and nutrition disorders
Creatinine
|
26.7%
4/15 • Number of events 8 • 54 months
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
20.0%
3/15 • Number of events 5 • 54 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
46.7%
7/15 • Number of events 12 • 54 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
20.0%
3/15 • Number of events 8 • 54 months
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Metabolism and nutrition disorders
Lipase
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
75.0%
6/8 • Number of events 12 • 54 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
53.3%
8/15 • Number of events 26 • 54 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-high (hyperphosphatemia)
|
46.7%
7/15 • Number of events 17 • 54 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
26.7%
4/15 • Number of events 9 • 54 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
33.3%
5/15 • Number of events 22 • 54 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
33.3%
5/15 • Number of events 6 • 54 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
46.7%
7/15 • Number of events 25 • 54 months
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
20.0%
3/15 • Number of events 4 • 54 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
20.0%
3/15 • Number of events 3 • 54 months
|
|
Nervous system disorders
Confusion
|
6.7%
1/15 • Number of events 2 • 54 months
|
|
Nervous system disorders
Dizziness
|
40.0%
6/15 • Number of events 9 • 54 months
|
|
Nervous system disorders
Mood alteration::Anxiety
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Mood alteration::Depression
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Neurology-Other (Specify, dizziness)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Neuropathy:sensory
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Tremor
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Eye disorders
Dry eye syndrome
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Eye disorders
Ocular surface disease
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Eye disorders
Vision-blurred vision
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Specify, extremity, limb)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
13.3%
2/15 • Number of events 3 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
13.3%
2/15 • Number of events 3 • 54 months
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Eye disorders
Pain::Eye
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Pain::Head/headache
|
46.7%
7/15 • Number of events 11 • 54 months
|
|
Ear and labyrinth disorders
Pain::Middle ear
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
40.0%
6/15 • Number of events 9 • 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Nervous system disorders
Pain::Neuralgia/peripheral nerve
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Throat/pharynx/larynx
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
6/15 • Number of events 7 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
26.7%
4/15 • Number of events 5 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
33.3%
5/15 • Number of events 6 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
6.7%
1/15 • Number of events 2 • 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Bladder spasms
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
General disorders
Flu-like symptoms
|
13.3%
2/15 • Number of events 2 • 54 months
|
|
Vascular disorders
Acute vascular leak syndrome
|
46.7%
7/15 • Number of events 12 • 54 months
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
6.7%
1/15 • Number of events 1 • 54 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.7%
1/15 • Number of events 1 • 54 months
|
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