Trial Outcomes & Findings for Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT03518112)
NCT ID: NCT03518112
Last Updated: 2022-11-04
Results Overview
Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L). Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
TERMINATED
PHASE2
6 participants
Time from the first day of treatment assessed up to 3 years, 1 month
2022-11-04
Participant Flow
Recruitment Period: April 2018 to May 2021
Participant milestones
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=6 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
47 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 monthTime from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L). Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Outcome measures
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=5 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death
|
5.7 Months
Interval 1.4 to 34.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsMinimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of \</= 0.01%.
Outcome measures
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=4 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Number of Participants Negative for Minimal Residual Disease (MRD)
|
4 Participants
|
SECONDARY outcome
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 monthResponse date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L). Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Outcome measures
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=4 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Duration of Response
|
4.4 Months
Interval 1.2 to 34.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsdefined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L).
Outcome measures
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=5 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Participants With a Response
|
4 Participants
|
SECONDARY outcome
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 monthTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=5 Participants
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
Overall Survival
|
16.7 Months
Interval 6.9 to 37.0
|
Adverse Events
Treatment (Blinatumomab, Combination Chemotherapy)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Blinatumomab, Combination Chemotherapy)
n=6 participants at risk
See detailed description.
Blinatumomab: Given IV
Cyclophosphamide: Given IV
Cytarabine: Given IT or IV
Dexamethasone: PO or IV
Filgrastim: Given SC
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Mercaptopurine: Given PO
Methotrexate: Given IT or IV
Pegfilgrastim: Given SC
Rituximab: Given IV
Vincristine Sulfate: Given IV
|
|---|---|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
General disorders
Headache
|
50.0%
3/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Nervous system disorders
Concentration Impairment
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
General disorders
Night Sweats
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
General disorders
Edema Legs
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
16.7%
1/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Investigations
Thrombocytopenia
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Blood and lymphatic system disorders
Neutopenia
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Blood and lymphatic system disorders
Decreased White Blood Count
|
33.3%
2/6 • Number of events 3 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Immune system disorders
Cytokine Release Syndrome
|
33.3%
2/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Cardiac disorders
Ventricular Tachycardia
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Investigations
Alanine Aminotransferase Increased
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
2/6 • Number of events 2 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Cardiac disorders
Steroid Myopathy
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Time from the first day of treatment assessed up to 3 years, 1 month
|
Additional Information
Dr. Elias Joseph Jabbour MD/Professor
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place