18 and older, any sex, with Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InOPrimary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
19
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO InitiationPrimary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Participants achieved CR/CRi during first salvage therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
6
Participants achieved CR/CRi during second salvage therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
11
Participants achieved CR/CRi during third salvage therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2
Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden DiseasePrimary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
Participants achieved CR/CRi: BMB <50%
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
10
Participants achieved CR/CRi: BMB >=50%
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
9
Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRiSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolor flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Participants with CR who achieved MRD
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
17
Participants with CRi who achieved MRD
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
1
Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRiSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of d
First Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
5
Second Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
11
Third Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2
Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRiSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined
BMB <50%
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
10
BMB >=50%
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
8
Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)Secondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2
Median Number of Cycles of InO TreatmentSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
The median number of cycles of InO a participant received during treatment were included. Standard dose of InO: 1.8 mg/m\^2 per 21 days cycle.
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2
1 – 6
Median Number of Cycles of InO Needed to Attain CR/CRiSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2
1 – 6
Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage TherapiesSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
First Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2.33
± 1.21
Second Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
2.00
± 1.48
Third Salvage Therapy
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
3.50
± 3.54
Duration of Remission (DOR)Secondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study.
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
6
0.5 – 61
Number of Participants Categorized as Per InO DosesSecondary· From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Standard dose of InO was 1.8 milligrams (mg) per meter square (m\^2) per cycle. Under dose of InO was less than 1.8 mg/m\^2 per cycle. Overdose of InO was more than 1.8 mg/m\^2 per cycle.
Under Dose
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
17
Standard Dose
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
12
Overdose
Group
Value
95% CI
Inotuzumab Ozogamicin (InO)
3
Adverse events — posted to ClinicalTrials.gov
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.
This retrospective Study enroll adult patients who:
* were CD22 positive (a molecule in the body that stops the over activity of the immune system)
* Received only InO for the treatment of B-cell ALL that occurred again after the last treatment
* were Philadelphia chromosome positive (which occurs because of changes in genes)
* failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division).
The patient data except their personal details are collected from a hospital based electronic medical record in India.
In this study the effectiveness and safety of InO will be studied after it was released to the market.
To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India:
* in whom the disease occurred again
* or those who never showed any improvement to earlier treatments
* now being treated with InO alone
Around 55 patients who have taken InO are likely to be enrolled in the study.
Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 4 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05597085.