Trial Outcomes & Findings for Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL) (NCT NCT00156013)
NCT ID: NCT00156013
Last Updated: 2017-11-29
Results Overview
Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
days 1 -28, maximum 6 cycles
Results posted on
2017-11-29
Participant Flow
Participant milestones
| Measure |
Clofarabine
Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)
Baseline characteristics by cohort
| Measure |
Clofarabine
n=33 Participants
Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
|
|---|---|
|
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
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: days 1 -28, maximum 6 cyclesPopulation: Per protocol guidelines for accrual to the cohorts.
Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.
Outcome measures
| Measure |
Clofarabine
n=33 Participants
During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
|
|---|---|
|
Phase I Maximum Tolerated Dose
|
6 mg/m^2
|
PRIMARY outcome
Timeframe: 5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Clofarabine
n=33 Participants
During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
|
|---|---|
|
Phase II Overall Response
patients achieving a complete response
|
7 Participants
|
|
Phase II Overall Response
patients achieving a partial response
|
6 Participants
|
|
Phase II Overall Response
Patients not achieving a response
|
20 Participants
|
SECONDARY outcome
Timeframe: 5 yearsNumber of Participants with Toxicity
Outcome measures
| Measure |
Clofarabine
n=33 Participants
During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
|
|---|---|
|
Toxicity
grade 3 or higher neutropenia or thrombocytopenia
|
20 Participants
|
|
Toxicity
neutropenia or thrombocytopenia less than grade 2
|
13 Participants
|
Adverse Events
Clofarabine
Serious events: 21 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clofarabine
n=33 participants at risk
Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
bilateral lower extremity celluiltis
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
fever of unknown origin
|
3.0%
1/33 • Number of events 1
|
|
Endocrine disorders
hyperglycemia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
hypokalemia
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
mental status changes
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
neutropenic fever
|
18.2%
6/33 • Number of events 6
|
|
Blood and lymphatic system disorders
pancytopenia
|
9.1%
3/33 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
3.0%
1/33 • Number of events 1
|
|
Renal and urinary disorders
renal failure
|
3.0%
1/33 • Number of events 1
|
|
Renal and urinary disorders
renal insufficiency
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
seizure
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
syncope
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.1%
2/33 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor lysis syndrome
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
abdominal pain
|
3.0%
1/33 • Number of events 1
|
Other adverse events
| Measure |
Clofarabine
n=33 participants at risk
Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
abdominal bloating
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
abdominal girth
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
abdominal pain
|
6.1%
2/33 • Number of events 2
|
|
Renal and urinary disorders
acute renal failure
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
Alk Phos
|
18.2%
6/33 • Number of events 6
|
|
General disorders
alopecia
|
9.1%
3/33 • Number of events 3
|
|
Blood and lymphatic system disorders
anemia
|
81.8%
27/33 • Number of events 27
|
|
General disorders
anion gap acidosis
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
angina
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ankle pain
|
3.0%
1/33 • Number of events 1
|
|
General disorders
anorexia
|
6.1%
2/33 • Number of events 2
|
|
Psychiatric disorders
anxiety
|
3.0%
1/33 • Number of events 1
|
|
General disorders
arm swelling
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
bacteremia
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
bilateral leg cramping and hand cramping
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
bilateral lower extremity erythema & swelling
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
bruising on forearms
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
18.2%
6/33 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
15.2%
5/33 • Number of events 5
|
|
Blood and lymphatic system disorders
creatinine
|
21.2%
7/33 • Number of events 7
|
|
Gastrointestinal disorders
decreased appetite
|
15.2%
5/33 • Number of events 5
|
|
Blood and lymphatic system disorders
decreased leukocytes
|
3.0%
1/33 • Number of events 1
|
|
General disorders
decreased performance status
|
3.0%
1/33 • Number of events 1
|
|
Renal and urinary disorders
decreased renal perfusion
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
delirium
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
depression
|
9.1%
3/33 • Number of events 3
|
|
Gastrointestinal disorders
diarrhea
|
9.1%
3/33 • Number of events 3
|
|
Ear and labyrinth disorders
difficulty hearing
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
dizziness
|
15.2%
5/33 • Number of events 5
|
|
Eye disorders
dry eyes
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
dry mouth
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
6.1%
2/33 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
15.2%
5/33 • Number of events 5
|
|
Ear and labyrinth disorders
ear pain
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
edema
|
15.2%
5/33 • Number of events 5
|
|
Blood and lymphatic system disorders
elevated albumin
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
elevated ANC
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
elevated AST/ALT
|
3.0%
1/33 • Number of events 1
|
|
General disorders
fatigue
|
42.4%
14/33 • Number of events 14
|
|
Infections and infestations
febrile neutropenia
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
fever
|
12.1%
4/33 • Number of events 4
|
|
General disorders
gingivitis
|
3.0%
1/33 • Number of events 1
|
|
Endocrine disorders
hyperglycemia
|
42.4%
14/33 • Number of events 14
|
|
Blood and lymphatic system disorders
granulcytopenia
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
headache
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
heartburn
|
6.1%
2/33 • Number of events 2
|
|
Renal and urinary disorders
hydronephrosis
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
hypernatremia
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
hypertension
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
hypoalbuminemia
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
hypokalemia
|
12.1%
4/33 • Number of events 4
|
|
Blood and lymphatic system disorders
hypocalcemia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
hypomagnsmia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
hyponatremia
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
hypotension
|
12.1%
4/33 • Number of events 4
|
|
Blood and lymphatic system disorders
hypovolemia
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
infection
|
6.1%
2/33 • Number of events 2
|
|
General disorders
ingrown toenail
|
3.0%
1/33 • Number of events 1
|
|
General disorders
chills
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
itching
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
15.2%
5/33 • Number of events 5
|
|
Blood and lymphatic system disorders
leukopenia
|
42.4%
14/33 • Number of events 14
|
|
Blood and lymphatic system disorders
low albumin
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
low magnesium
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
low phosphorus
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
lymphopenia
|
3.0%
1/33 • Number of events 1
|
|
General disorders
malaise
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
mucositis
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
48.5%
16/33 • Number of events 16
|
|
Nervous system disorders
neuropathy
|
3.0%
1/33 • Number of events 1
|
|
Blood and lymphatic system disorders
neutropenia
|
84.8%
28/33 • Number of events 28
|
|
General disorders
night sweats
|
6.1%
2/33 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
orthostatic hypotension
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
palpitations
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
paralytic ileus
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
pharyngitis
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
protein calorie malnutrition
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
protein low
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritis
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
9.1%
3/33 • Number of events 3
|
|
Renal and urinary disorders
renal artery vasoconstruction
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
right pleural effusion
|
9.1%
3/33 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
runny nose
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
SGOT
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
SGPT
|
12.1%
4/33 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
15.2%
5/33 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
sinus problems
|
6.1%
2/33 • Number of events 2
|
|
Cardiac disorders
systoloc ejection murmur
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
9.1%
3/33 • Number of events 3
|
|
Blood and lymphatic system disorders
bilirubin
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
100.0%
33/33 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
vomiting
|
30.3%
10/33 • Number of events 10
|
|
General disorders
weakness
|
15.2%
5/33 • Number of events 5
|
|
General disorders
weight gain
|
3.0%
1/33 • Number of events 1
|
|
General disorders
weight loss
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
9.1%
3/33 • Number of events 3
|
|
General disorders
pain
|
21.2%
7/33 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60