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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• Leukemia 5,441
• Precursor Cell Lymphoblastic Leukemia-Lymphoma 2,061
• Leukemia, Lymphoid 1,780

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

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 32 is below the median of 120 across 744 observational studies indexed under Leukemia.

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study population

Groups and cohorts

• 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

• DrugInotuzumab Ozogamicin

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

  Also known as: Besponsa, Inonza

Primary outcomes

1. 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.

   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)

2. 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.

   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)

3. 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%.

   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)

Secondary outcomes

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

   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.

   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)

2. 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

   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 drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. Participants with either CR or CRi who achieved MRD negativity classified per number of lines of salvage therapies are reported in this outcome measure.

   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)

3. 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

   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 using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. Participants with either CR or CRi who achieved MRD negativity classified per high burden and low burden disease are reported in this outcome measure.

   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)

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

   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.

   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)

5. Median Number of Cycles of InO Treatment

   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.

   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)

6. Median Number of Cycles of InO Needed to Attain CR/CRi

   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.

   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)

7. Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies

   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.

   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)

8. Duration of Remission (DOR)

   Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study.

   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)

9. Number of Participants Categorized as Per InO Doses

   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.

   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)

10. Number of Participants With InO Dose Modifications

    Number of participants for whom there was deviation in InO dose from the standard dose (1.8 mg/ m\^2 per cycle) were included.

    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)

11. Number of Participants Who Received Concomitant Medications

    Concomitant medication was defined as any medication other than, and in addition to, the study medication taken for any period of time during the treatment.

    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)

12. Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)

    HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases.

    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)

13. Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity

    Survival rate: percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. 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 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. In this outcome measure percentage of participants who had either CR or CRi with MRD negativity and survived at the end of 6 months and 12 months post initiation of InO treatment are reported on the basis of transplantation status.

    Time frame: 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)

14. Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies

    Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on number of lines of salvage therapies.

    Time frame: 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)

15. Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease

    Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on high burden and low burden disease.

    Time frame: 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)

16. Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)

    Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. In this outcome measure percentage of transplanted and non-transplanted participants greater than 65 years of age, who survived at the end of 6 months and 12 months post initiation of InO treatment are reported.

    Time frame: 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)

17. Number of Participants Categorized According to Cause of Death

    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)

18. Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT

    RFS was defined as time from index date to the earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), or the start of new induction therapy or posttherapy HSCT without achieving CR/CRi. Index date was defined as the date of initiation of the first cycle of InO. 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. Median duration of relapse free survival in all participants included those participants who had achieved CR/CRi is reported in this outcome measure.

    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)

19. Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD

    VOD occurs when the small blood vessels in the liver are blocked.

    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)

20. Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies

    VOD occurs when the small blood vessels in the liver are blocked. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.

    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)

21. Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease

    VOD occurs when the small blood vessels in the liver are blocked. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.

    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)

22. Percentage of Participants With VOD in Elderly Participants (>65 Years)

    VOD occurs when the small blood vessels in the liver are blocked.

    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)

23. Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation

    Treatment-related AE was any untoward medical occurrence in a participant who has received the study drug. Liver toxicity parameters included: Aspartate aminotransferase (level) \>=2.5\*upper limit of normal (ULN); alanine transaminase (level) \>=2.5\*ULN and total serum bilirubin \>=1.5\*ULN. Here, Grade 3 indicates severe events and Grade 4 indicates Life-threatening events where urgent intervention was required.

    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)

24. Number of Participants With Hematological Toxicities Following InO Initiation

    Hematological toxicities included: Febrile neutropenia= absolute neutrophil count (ANC) \< 1.0\*10\^9 cells/L, fever \>=38.5 degree C); Neutropenia= absolute granulocyte count \< 1.0\*10\^9 cells/L; Thrombocytopenia= platelet count \< 150,000 platelets per microliter.

    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)

25. Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi

    Extramedullary disease was the presence of leukemic cell aggregates in the form of solid tumor outside that of bone marrow. Lymphoblastic lymphoma, was a clonal hematopoietic stem cell disorder of B or T cell origin. 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.

    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)

Baseline characteristics

Related links

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

Study documents

• Study protocol · Nov 14, 2022
• Statistical analysis plan · May 4, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.