A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

NCT05597085 | Completed Results FDA Drug

• 2 other identifiers: B1931043NCT05597085
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO

  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.

  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)

• 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

  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.

  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)

• Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease

  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%.

  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 (25)

• Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi

  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)

• 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

  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)

• 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

  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)

• Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)

  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)

• Median Number of Cycles of InO Treatment

  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)

Study Arms (1)

Adult relapsed or refractory B Cell ALL

Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment

Drug: Inotuzumab Ozogamicin

Interventions

Inotuzumab Ozogamicin DRUG

Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL

Also known as: Besponsa, Inonza

Adult relapsed or refractory B Cell ALL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Fortis Memorial Research Institute

Gurugram, Haryana, 122002, India

Location

Malabar Cancer Center

Thalassery, Kerala, 670103, India

Location

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Indo-American Cancer & Research Centre

Hyderabad, Telangana, 500034, India

Location

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Burkitt Lymphoma; Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: March 8, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)