Trial Outcomes & Findings for Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia (NCT NCT02135874)
NCT ID: NCT02135874
Last Updated: 2024-03-22
Results Overview
Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 2 months
Results posted on
2024-03-22
Participant Flow
Participant milestones
| Measure |
Treatment (Combination Chemotherapy)
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Combination Chemotherapy)
n=16 Participants
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 monthsResponse is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
Outcome measures
| Measure |
Treatment (Combination Chemotherapy)
n=16 Participants
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Participants Complete Response
|
9 Participants
|
SECONDARY outcome
Timeframe: At 4 weeksNumber of participants who died after 4 weeks of treatment.
Outcome measures
| Measure |
Treatment (Combination Chemotherapy)
n=16 Participants
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
4-week Mortality Rate
|
1 Participants
|
Adverse Events
Treatment (Combination Chemotherapy)
Serious events: 11 serious events
Other events: 16 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Combination Chemotherapy)
n=16 participants at risk
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Cardiac disorders
Cardiac Arrest
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Central Line blood stream Infection
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Cardiac disorders
Chest Pain
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
31.2%
5/16 • Number of events 7 • Up to 8 years
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Lung Infection
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Mucositis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Pneumonia
|
25.0%
4/16 • Number of events 5 • Up to 8 years
|
|
Surgical and medical procedures
Right Atrial Thrombus removal
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Vascular disorders
Thromboembolic Event
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Tooth Infection
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Upper Respiratory Infection
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Bacteremia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Renal and urinary disorders
Acute Renal Failure
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Sepsis Tracheal Aspiration
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
Other adverse events
| Measure |
Treatment (Combination Chemotherapy)
n=16 participants at risk
See Detailed Description.
Clofarabine: Given IV
Cytarabine: Given IV
Dexamethasone: Given IV
Idarubicin: Given IV
Rituximab: Given IV
Sorafenib: Given PO
Sorafenib Tosylate: Given PO
Vincristine: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Fluid Imbalance
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Indigestion
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Metabolism and nutrition disorders
Transaminitis
|
31.2%
5/16 • Number of events 5 • Up to 8 years
|
|
Ear and labyrinth disorders
Pain Ear
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Musculoskeletal and connective tissue disorders
Pain Jaw
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Back Pain
|
18.8%
3/16 • Number of events 3 • Up to 8 years
|
|
Cardiac disorders
Pericarditis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Blood and lymphatic system disorders
Elevated INR
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
4/16 • Number of events 4 • Up to 8 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
4/16 • Number of events 4 • Up to 8 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Headache
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Bruise
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Nervous system disorders
Multiple sclerosis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Immune system disorders
Immunosuppression
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Infections and infestations
Cellulitis- L great toe
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
General disorders
Facial swelling
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Infections and infestations
Infection skin lesion
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
2/16 • Number of events 2 • Up to 8 years
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
4/16 • Number of events 4 • Up to 8 years
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • Number of events 5 • Up to 8 years
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Renal and urinary disorders
acute Kidney Injury
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Febrile Neutropenia
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Blood and lymphatic system disorders
Elevated Creatinine
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Gastrointestinal disorders
Paralytic Ileus
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
|
Infections and infestations
Nail Infection
|
6.2%
1/16 • Number of events 1 • Up to 8 years
|
Additional Information
Elias Jabbour MD/Proffessor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-4764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place