## Protocol Section
### Identification Module
**NCT ID:** NCT06427330

**Brief Title:** Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

**Official Title:** Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia

#### Organization Study ID Info
**ID:** IIT2024022-EC-1
#### Organization
**Class:** OTHER
**Full Name:** Institute of Hematology & Blood Diseases Hospital, China
### Status Module
#### Completion Date
**Date:** 2026-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institute of Hematology & Blood Diseases Hospital, China

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.

**Detailed Description:** This is a Phase II study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for ALL and have a high risk of relapse. Participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first Primary Objective

• To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (DFS) at one year.

Secondary Objective(s)

* To evaluate relapse rate, nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
* To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(AE)/severe adverse event(SAEs)

### Conditions Module

**Conditions:**

- Acute Lymphoid Leukemia

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 21

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Inotuzumab ozogamicin

**Label:** Inotuzumab ozogamicin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Inotuzumab ozogamicin

**Description:** 1. st dose is given after D+60：inotuzumab 0.3mg/m2
2. nd dose is given after 1 month：inotuzumab 0.6mg/m2

**Name:** Inotuzumab ozogamicin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".

**Measure:** DFS

**Time Frame:** at one year after HSCT

#### Secondary Outcomes

**Description:** Defined from time from HSCT to death due to any cause Defined from time from date of HSCT to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10

**Measure:** Overall survival

**Time Frame:** at one year after HSCT

**Description:** Defined as time from date of HSCT to the date of first relapse. Reported as Cumulative Incidence

**Measure:** Relapse

**Time Frame:** at one year after HSCT

**Description:** Defined as time from date of first dose to death due to any cause without prior relapse.

**Measure:** NRM

**Time Frame:** at one year after HSCT

**Description:** Number of patients who develop hematological toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia, etc.

**Measure:** Incidence of hematological toxicity

**Time Frame:** at one year after HSCT

**Description:** Number of patients who develop secondary graft failure while on study, defined as: Either cytopenias after initial engraftment (ANC \<500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was \>5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced

**Measure:** Incidence of secondary graft failure(GF)

**Time Frame:** at one year after HSCT

**Description:** safety profile of intervention as measured by percent of participants with any grade AE/SAEs

**Measure:** Percent of participants with AE/SAEs

**Time Frame:** at one year after HSCT

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
* Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
* Patients who are after T+60 after transplantation
* Patients who have/are either:

  * High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic
  * Leukemia
  * Relapsed or refractory to at least 1 line of treatment
  * Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test
* Patients who have \> 99% donor chimerism after allogeneic transplantation.
* Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2
* Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
* ≥ 18 years old, including male and female
* Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with evidence of disease progression prior to enrollment
* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
* Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:

  * Severe renal deficiency, with creatinine clearance \< 50ml/min
  * Severe hepatic deficiency
  * Bilirubin, aspartate aminotransferase(AST), and/or ALT(ALT) \> 2X institutional upper limit of normal
  * Severe cardiac or pulmonary deficiency
* Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).
* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
* History of veno-occlusive disease(VOD)
* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)
* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tianjin

**Country:** China

**Facility:** Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M27585

- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoid Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphoid Leukemia

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T175

- Name: Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3533

- Name: Lymphoblastic Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoid Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000054198

- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- ID: D000007945

- Term: Leukemia, Lymphoid

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000000922

- Term: Immunotoxins

- ID: D000018796

- Term: Immunoconjugates

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M2103

- Name: Inotuzumab Ozogamicin

- Relevance: HIGH

- As Found: g/L

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4241

- Name: Immunotoxins

- Relevance: LOW

- As Found: Unknown

- ID: M20855

- Name: Immunoconjugates

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000080045

- Term: Inotuzumab Ozogamicin

### Misc Info Module

- Version Holder: 2024-05-31
