Trial Outcomes & Findings for Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach (NCT NCT00250718)
NCT ID: NCT00250718
Last Updated: 2015-08-03
Results Overview
Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0). For CLL: complete remission (CR) requires the following for\>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count\<4,000/µL, 4) ANC\>1,500/µL, 5) platelets\>100,000/µL, 6) hemoglobin\>11 g/dL, 7) bone marrow lymphocytosis\<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for \>=2 months 1) decrease in previously enlarged nodes, spleen, and liver by \>=50%, 2) ANC\>=1,500/µL or platelets\>=100,000/µL, 3) hemoglobin\>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets. For MM, CR is no monoclonal protein (M-protein) in blood and urine and \<5% plasma cells in bone marrow on \>=2 determinations \>=6 wk apart \& stable bone disease \& calcium levels. PR is\>50% and \>90% decreases in serum \& urine M-protein, respectively, on \>=2 occasions for \>=6 wk, stable bone disease \& calcium.
TERMINATED
PHASE2
17 participants
Up to 6 months after first on-study treatment
2015-08-03
Participant Flow
Participant milestones
| Measure |
Arm 1 Combination Treatment
VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Received Treatment
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arm 1 Combination Treatment
VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach
Baseline characteristics by cohort
| Measure |
Arm 1 Combination Treatment
n=17 Participants
VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily
One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient
|
|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after first on-study treatmentPopulation: Trial was terminated due to low accrual; no data to report. An insufficient number of subjects were accrued to report data accurately.
Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0). For CLL: complete remission (CR) requires the following for\>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count\<4,000/µL, 4) ANC\>1,500/µL, 5) platelets\>100,000/µL, 6) hemoglobin\>11 g/dL, 7) bone marrow lymphocytosis\<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for \>=2 months 1) decrease in previously enlarged nodes, spleen, and liver by \>=50%, 2) ANC\>=1,500/µL or platelets\>=100,000/µL, 3) hemoglobin\>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets. For MM, CR is no monoclonal protein (M-protein) in blood and urine and \<5% plasma cells in bone marrow on \>=2 determinations \>=6 wk apart \& stable bone disease \& calcium levels. PR is\>50% and \>90% decreases in serum \& urine M-protein, respectively, on \>=2 occasions for \>=6 wk, stable bone disease \& calcium.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of 2 cycles (cycle = 28 days)Population: Trial was terminated early due to low accrual; no data to report. Adverse event data for enrolled patients is reported in the adverse event results section.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 Combination Treatment
Serious adverse events
| Measure |
Arm 1 Combination Treatment
n=16 participants at risk
VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd
Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.
VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.
Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.
Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Levofloxacin: Levofloxacin will be administ
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
6.2%
1/16 • Number of events 2
|
|
Cardiac disorders
Arrhythmia (irregular heartbeat)
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia (high blood sugar)
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Arm 1 Combination Treatment
n=16 participants at risk
VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd
Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.
VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.
Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.
Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.
Levofloxacin: Levofloxacin will be administ
|
|---|---|
|
Immune system disorders
Allergic rhinitis (runny nose)
|
6.2%
1/16 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus (ringing in the ears)
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
8/16 • Number of events 20
|
|
Blood and lymphatic system disorders
Leukocytes decreased
|
31.2%
5/16 • Number of events 23
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
43.8%
7/16 • Number of events 28
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
31.2%
5/16 • Number of events 10
|
|
Cardiac disorders
Hypotension (low blood pressure)
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
68.8%
11/16 • Number of events 14
|
|
General disorders
Fever
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Rigors (stiffness)
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Increased sweating
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Weight loss
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia (Hair loss)
|
25.0%
4/16 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia (Loss of appetite)
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
37.5%
6/16 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Taste disturbance
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Epistaxis (Nosebleed)
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Edema: limbs
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Hypercalcemia (High calcium levels)
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Hyperglycemia (High blood glucose)
|
12.5%
2/16 • Number of events 3
|
|
Investigations
Hyperuricemia (High uric acid)
|
6.2%
1/16 • Number of events 3
|
|
Investigations
Hypoalbuminemia (Low albumin levels)
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Hypocalcemia (Low calcium levels)
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Hypokalemia (Low potassium levels)
|
31.2%
5/16 • Number of events 6
|
|
Investigations
Hypomagnesemia (Low magnesium levels)
|
6.2%
1/16 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Agitation
|
12.5%
2/16 • Number of events 3
|
|
Nervous system disorders
Anxiety
|
12.5%
2/16 • Number of events 3
|
|
Nervous system disorders
Ataxia (Lack of muscle coordination)
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Confusional state
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Convulsions
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Depression
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
25.0%
4/16 • Number of events 4
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
18.8%
3/16 • Number of events 3
|
|
Nervous system disorders
Neurology - Other
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Extraocular muscle disorder
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 3
|
|
General disorders
Abdominal pain
|
31.2%
5/16 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Muscle pain)
|
18.8%
3/16 • Number of events 3
|
|
Nervous system disorders
Neuralgia (Nerve pain)
|
6.2%
1/16 • Number of events 17
|
|
General disorders
Pain - Other
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.8%
7/16 • Number of events 10
|
|
General disorders
Scrotal pain
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
12.5%
2/16 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Decreased libido
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place