Clinical trial NCT05597085: A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment
Official title: A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
Keywords: Relapsed ALL
Refractory ALL
Adult Relapsed/Refractory ALL
Adult ALL
Relapsed B Cell ALL
Refractory B Cell ALL
Relapsed Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Patients

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years old at the initiation of InO treatment

  * Patients with relapsed/refractory B-cell ALL
  * Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
  * Ph+ patients who have failed treatment with at least 1 TKI

Exclusion Criteria:

* Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy

Primary outcomes:
measure: Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
timeFrame: 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)
measure: 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 Initiation
timeFrame: 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)
measure: Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease
timeFrame: 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)
Secondary outcomes:
measure: Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi
timeFrame: 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)
measure: Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi
timeFrame: 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)
measure: Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi
timeFrame: 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)
measure: Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)
timeFrame: 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)
measure: Median Number of Cycles of InO Treatment
timeFrame: 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)
measure: Median Number of Cycles of InO Needed to Attain CR/CRi
timeFrame: 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)
measure: Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies
timeFrame: 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)
measure: Duration of Remission (DOR)
timeFrame: 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)
measure: Number of Participants Categorized as Per InO Doses
timeFrame: 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)
measure: Number of Participants With InO Dose Modifications
timeFrame: 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)
measure: Number of Participants Who Received Concomitant Medications
timeFrame: 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)
measure: Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)
timeFrame: 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)
measure: Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
timeFrame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
measure: Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
timeFrame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
measure: Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
timeFrame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
measure: Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)
timeFrame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
measure: Number of Participants Categorized According to Cause of Death
timeFrame: 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)
measure: Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT
timeFrame: 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)
measure: Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD
timeFrame: 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)
measure: Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies
timeFrame: 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)
measure: Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease
timeFrame: 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)
measure: Percentage of Participants With VOD in Elderly Participants (>65 Years)
timeFrame: 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)
measure: Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation
timeFrame: 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)
measure: Number of Participants With Hematological Toxicities Following InO Initiation
timeFrame: 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)
measure: Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi
timeFrame: 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)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
state: Delhi
city: Gurugram
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Thalassery
country: India
facility: Malabar Cancer Center
state: Kerala
city: Hyderabad
country: India
facility: Indo-American Cancer & Research Centre
state: Telangana
city: Kolkata
country: India
facility: Tata Medical Center
state: WEST Bengal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: