Trial Outcomes & Findings for Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (NCT NCT05032183)
NCT ID: NCT05032183
Last Updated: 2025-08-11
Results Overview
Response is defined as Complete Response CR + Complete Response with inadequate count recovery (CRi) - (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. (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).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Within 3 cycles of treatment initiation
Results posted on
2025-08-11
Participant Flow
Participant milestones
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=4 Participants
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
31 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 3 cycles of treatment initiationPopulation: Of the four participants registered on study, three participants were evaluable for response.
Response is defined as Complete Response CR + Complete Response with inadequate count recovery (CRi) - (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. (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 |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=3 Participants
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Participants With a Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 cycles of treatment initiationPopulation: Of the four participants registered on study, three participants were evaluable for response.
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.
Outcome measures
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=3 Participants
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Participants With a Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to two years, 5 months, and 4 daysPopulation: Of the four participants registered on study, three participants were evaluable for response.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=3 Participants
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Relapsed-free Survival (RFS)
|
NA Months
There were zero responses in the three evaluable patients.
|
SECONDARY outcome
Timeframe: Up to two years, 5 months, and 4 daysPopulation: Of the four participants registered on study, three participants were evaluable for response.
Kaplan-Meier method will be used to estimate the overall survival.
Outcome measures
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=3 Participants
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Overall Survival
|
3.8 Months
Interval 1.7 to 5.3
|
Adverse Events
Phase I Treatment (Tagraxofusp, Chemotherapy)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=4 participants at risk
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Vascular disorders
Capillary leak syndrome
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Infections and infestations
Lung infection
|
50.0%
2/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
General disorders
Non-cardiac chest pain
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
Other adverse events
| Measure |
Phase I Treatment (Tagraxofusp, Chemotherapy)
n=4 participants at risk
See Detailed Description
Cyclophosphamide: Given IV
Cytarabine: Given IT
Dexamethasone: Given IV or PO
Filgrastim-sndz: Given SC
Leucovorin: Given IV
Mercaptopurine: Given PO
Mesna: Give IV
Methotrexate: Given IT
Pegfilgrastim: Given SC
Prednisone: Given PO
Rituximab: Given IV
Tagraxofusp-erzs: Given IV
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
100.0%
4/4 • Number of events 7 • Up to two years, 5 months, and 4 days
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Investigations
Bacteremia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Eye disorders
Blurred vision
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Vascular disorders
Capillary leak syndrome
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Investigations
Creatinine increased
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
75.0%
3/4 • Number of events 5 • Up to two years, 5 months, and 4 days
|
|
General disorders
Edema limbs
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Eye disorders
Eye disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
Investigations
Fibrinogen decreased
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
3/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
75.0%
3/4 • Number of events 5 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
2/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
75.0%
3/4 • Number of events 6 • Up to two years, 5 months, and 4 days
|
|
Investigations
INR increased
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Investigations
Investigations - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Vascular disorders
Lymphedema
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
75.0%
3/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
General disorders
Non-cardiac chest pain
|
50.0%
2/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Cardiac disorders
Pericardial effusion
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
75.0%
3/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
25.0%
1/4 • Number of events 3 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
2/4 • Number of events 4 • Up to two years, 5 months, and 4 days
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 2 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Number of events 1 • Up to two years, 5 months, and 4 days
|
Additional Information
Ghayas Issa MD./Associate Professor
The Univeristy of Texas MD Anderson Cancer Center
Phone: 713-745-6798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place