Trial Outcomes & Findings for Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia (NCT NCT03094611)

Last Updated: 2021-04-12

Results Overview

Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2021-04-12

Participant Flow

Recruitment Period: January 2017 to January 2019

Participant milestones

Participant milestones
Measure	Treatment (Inotuzumab Ozogamicin) Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Inotuzumab Ozogamicin) Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Overall Study Lack of Efficacy	1
Overall Study Stem Cell Transplant	1

Baseline Characteristics

Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	46 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	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: Up to 2 years

Outcome measures

Outcome measures
Measure	Treatment (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Number of Participants to Achieve Complete Remission (CR)	3 Participants

SECONDARY outcome

Timeframe: Up to 2 years

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 (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)	1 Participants

SECONDARY outcome

Timeframe: Up to 3 years

The date of Complete Response to the date of loss of response or last follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Duration of Response	17.0 Months Interval 11.1 to 31.8

SECONDARY outcome

Timeframe: Up to 3 years

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Outcome measures

Outcome measures
Measure	Treatment (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Progression Free Survival	11.7 Months Interval 0.4 to 32.7

SECONDARY outcome

Timeframe: Up to 3 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 (Inotuzumab Ozogamicin) n=4 Participants Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Overall Survival	19.6 Months Interval 1.5 to 32.7

Adverse Events

Treatment (Inotuzumab Ozogamicin)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Inotuzumab Ozogamicin) n=4 participants at risk Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Treatment (Inotuzumab Ozogamicin) n=4 participants at risk Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles. Inotuzumab Ozogamicin: Given IV
Investigations Alkaline Phosphatase Increased	75.0% 3/4 • Number of events 3 • Up to 2 years
Investigations Aspartate Aminotransferase Increased	75.0% 3/4 • Number of events 3 • Up to 2 years
Investigations Hyperbilirubinemia	50.0% 2/4 • Number of events 3 • Up to 2 years
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 2 • Up to 2 years
General disorders Headache	50.0% 2/4 • Number of events 2 • Up to 2 years
Gastrointestinal disorders Nausea	75.0% 3/4 • Number of events 3 • Up to 2 years
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Fever	25.0% 1/4 • Number of events 1 • Up to 2 years
General disorders Rash	25.0% 1/4 • Number of events 1 • Up to 2 years
Gastrointestinal disorders Abdominal Distension	25.0% 1/4 • Number of events 1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Up to 2 years
Investigations Alanine Aminotransferase Increase	25.0% 1/4 • Number of events 1 • Up to 2 years
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to 2 years
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Number of events 1 • Up to 2 years
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Number of events 1 • Up to 2 years

Additional Information

Elias Jabbour, MD./ Professor, Leukemia

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