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

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ClinicalTrials.gov Identifier: NCT05597085
Recruitment Status : Not yet recruiting
First Posted : October 27, 2022
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment
Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia Drug: Inotuzumab Ozogamicin

Study Design
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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Inotuzumab Ozogamicin Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL
Other Names:
  • Besponsa
  • Inonza


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 1st salvage [ Time Frame: From last dose of InO; up to 6 months ]
  2. Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 2nd salvage [ Time Frame: From last dose of InO; up to 6 months ]
  3. Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 3rd salvage [ Time Frame: From last dose of InO; up to 6 months ]
  4. Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in >3 lines of salvage [ Time Frame: From last dose of InO; up to 6 months ]

Secondary Outcome Measures :
  1. Percentage of participants achieving Minimum Residual Disease (MRD) Negativity in participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) [ Time Frame: Up to approximately 6 months from last dose of InO ]
    MRD analysis performed in participants who achieved CR or CRi. Bone marrow aspirates, collected and sent to laboratory and analyzed using multiparametric flow cytometry

  2. Number of cycles of InO needed to attain CR/CRi determined by laboratory testing [ Time Frame: Up to 6 months after the last dose of InO ]
  3. Duration of Remission (DoR) for participants who achieved CR/CRi (per investigator assessment). [ Time Frame: Up to 6 months after the last dose of InO ]
    DoR was defined as time from date of first response in responders (CR/CRi per investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi).

  4. Number of participants categorized according to dose modifications [ Time Frame: Up to 6 months after the last dose of InO ]
  5. Number of participants categorized according to number of cycles [ Time Frame: Up to 6 months from last dose of InO ]
  6. Number of participants with concomitant medications [ Time Frame: Upto 6 months after last dose of InO ]
  7. Hematopoietic stem cell transplantation (HSCT) rate was defined as the percentage of participants who underwent stem cell transplantation (SCT) following treatment with InO [ Time Frame: Up to 6 months from last dose ]
    Number of patients who proceed to transplant

  8. Overall survival (OS) in transplanted participants [ Time Frame: At 6 months and 1 year after the last dose of InO ]
    OS is defined as the time from start of therapy to date of death due to any cause.

  9. Overall survival (OS) in non transplanted participants [ Time Frame: At 6 months & 1 year after the last dose of InO ]
    OS is defined as the time from start of therapy to date of death due to any cause.

  10. Number of participants categorized according to cause of death [ Time Frame: At 6 months & 1 year after the last dose of InO ]
  11. Relapse-free-survival in months determined by progression of disease and flowcytometric evaluation (all participants) [ Time Frame: From last dose of InO; up to 6 months & 12 months ]
  12. Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants with follow up HSCT) [ Time Frame: Up to 6 months & 1 year after last dose of InO ]
  13. Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants without follow up HSCT) [ Time Frame: From last dose of InO; up to 6 months & 12 months ]
  14. Rate of Hepatic veno-occlusive disease (VOD) in transplanted participants determined by Liver function tests [ Time Frame: Up to 1 year from last dose of InO ]
    VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.

  15. Rate of Hepatic veno-occlusive disease (VOD) in non-transplanted participants determined by Liver function tests [ Time Frame: Up to 1 year from last dose of InO ]
    VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.

  16. Number of participants reporting Grade 3/4 treatment related Adverse Events following InO initiation [ Time Frame: Up to 1 year from last dose of InO ]
    Grades 3 are severe and undesirable adverse events and grade 4 are life threatening or disabling adverse events

  17. Percentage of participants who achieved complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) in extramedullary disease and Lymphoblastic Lymphoma (LBL) [ Time Frame: Up to 1 year from last dose of InO ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Patients
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597085


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05597085    
Other Study ID Numbers: B1931043
First Posted: October 27, 2022    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Inotuzumab Ozogamicin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antibiotics, Antineoplastic