Trial Outcomes & Findings for Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia (NCT NCT03488225)

Last Updated: 2024-07-16

Results Overview

Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Start of treatment up to 2 years

Results posted on

2024-07-16

Participant Flow

Recruitment Period: March 2018 to January 2019

Participant milestones

Participant milestones
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Overall Study Off Protocol Therapy	2
Overall Study Stem Cell Transplant	2

Baseline Characteristics

Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	3 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: Start of treatment up to 2 years

Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse.

Outcome measures

Outcome measures
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Event-Free Survival	24 Months Interval 18.5 to 24.0

SECONDARY outcome

Timeframe: Start of treatment up to 2 years

Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Overall Survival	24 Months Interval 18.5 to 24.0

SECONDARY outcome

Timeframe: Start of treatment up to 2 years

Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts \</= 5% in normocellular or hypercellular marrow, granulocyte count of 1x10\^9/L or above and platelets \>/= 100X10\^9/L and complete resolution of all sites of extramedullary disease.

Outcome measures

Outcome measures
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Participants to Achieve Complete Remission (CR):	4 Participants

SECONDARY outcome

Timeframe: Start of treatment up to 2 years

MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle.

Outcome measures

Outcome measures
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Number of Participants With Minimal Residual Disease (MRD) Negativity	4 Participants

SECONDARY outcome

Timeframe: Start of treatment up to 30 days after last dose received.

For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.

Outcome measures

Outcome measures
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 Participants See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Number of Participants With Adverse Events Neutropenic Fever	2 Participants
Number of Participants With Adverse Events Peripheral Sensory Neuropathy	1 Participants
Number of Participants With Adverse Events Allergic Reaction	1 Participants
Number of Participants With Adverse Events Muscle Weakness	1 Participants

Adverse Events

Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 participants at risk See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Blood and lymphatic system disorders Neutropenic Fever	50.0% 2/4 • Number of events 2 • Up to 2 years
Infections and infestations Kidney Infection	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Fever	50.0% 2/4 • Number of events 2 • Up to 2 years
Musculoskeletal and connective tissue disorders Muscle Weakness	25.0% 1/4 • Number of events 1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) n=4 participants at risk See detailed description. Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: Given IV or PO Doxorubicin Hydrochloride: Given IV Inotuzumab Ozogamicin: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT, IV or PO Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
Gastrointestinal disorders Abdominal Pain	50.0% 2/4 • Number of events 2 • Up to 2 years
Investigations Alanine Aminotransferase Increased	50.0% 2/4 • Number of events 3 • Up to 2 years
Immune system disorders Allergic Reaction	50.0% 2/4 • Number of events 2 • Up to 2 years
Gastrointestinal disorders Anorexia	25.0% 1/4 • Number of events 1 • Up to 2 years
Eye disorders Blurred Vision	25.0% 1/4 • Number of events 1 • Up to 2 years
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 2 • Up to 2 years
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Edema Limbs	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Up to 2 years
Nervous system disorders Headache	75.0% 3/4 • Number of events 3 • Up to 2 years
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Number of events 1 • Up to 2 years
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Infusion Related Reaction	50.0% 2/4 • Number of events 2 • Up to 2 years
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Up to 2 years
Investigations Neutropenia	75.0% 3/4 • Number of events 3 • Up to 2 years
General disorders Non-Cardiac Chest Pain	50.0% 2/4 • Number of events 2 • Up to 2 years
Gastrointestinal disorders Oral Mucositis	75.0% 3/4 • Number of events 4 • Up to 2 years
Nervous system disorders Peripheral Sensory Neuropathy	100.0% 4/4 • Number of events 4 • Up to 2 years
Cardiac disorders Sinus Bradycardia	50.0% 2/4 • Number of events 2 • Up to 2 years
Investigations Thrombocytopenia	75.0% 3/4 • Number of events 3 • Up to 2 years
Gastrointestinal disorders Vomiting	50.0% 2/4 • Number of events 2 • Up to 2 years
General disorders Pain	25.0% 1/4 • Number of events 2 • Up to 2 years
Nervous system disorders Arachnoiditis	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Gait Disturbance	25.0% 1/4 • Number of events 1 • Up to 2 years

Additional Information

Elias Joseph Jabbour, MD./ Professor

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