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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia (NCT03104491) is a Phase 1 / Phase 2 interventional studying Acute Lymphocytic Leukemia, sponsored by Leland Metheny. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Acute Lymphocytic Leukemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 44 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Phase 1 Inclusion Criteria - Diagnosis of CD22-positive Acute Lymphoblastic Leukemia - Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia - Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100. - Patients who have/are either: - Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation ---Pre- or Post-Transplant Minimal Residual Disease defined by: ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication. - In second or third complete remission at the time of allogeneic transplantation - Treated with reduced intensity regimens or non-myeloablative conditioning regimens - Lymphoid blast crisis of CML - Are relapsed or refractory to at least 1 line of chemotherapy - Philadelphia-like ALL - Patients who have evidence of donor chimerism after allogeneic transplantation. - 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. - Able to adhere to the study visit schedule and other protocol requirements. - Participants must have the ability to understand and the willingness to sign a written willing to sign a consent form document. Phase 2 Inclusion Criteria - Diagnosis of CD22-positive Acute Lymphoblastic Leukemia - Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia - Patients who are between T+40 and T+100 after allogeneic transplantation - Patients who have/are either: - Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Phase 1 Inclusion Criteria * Diagnosis of CD22-positive Acute Lymphoblastic Leukemia * Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia * Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100. * Patients who have/are either: * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation ---Pre- or Post-Transplant Minimal Residual Disease defined by: ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication. * In second or third complete remission at the time of allogeneic transplantation * Treated with reduced intensity regimens or non-myeloablative conditioning regimens * Lymphoid blast crisis of CML * Are relapsed or refractory to at least 1 line of chemotherapy * Philadelphia-like ALL * Patients who have evidence of donor chimerism after allogeneic transplantation. * 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. * Able to adhere to the study visit schedule and other protocol requirements. * Participants must have the ability to understand and the willingness to sign a written informed consent document. Phase 2 Inclusion Criteria * Diagnosis of CD22-positive Acute Lymphoblastic Leukemia * Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia * Patients who are between T+40 and T+100 after allogeneic transplantation * Patients who have/are either: * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation ---Post-Transplant Minimal Residual Disease defined by: ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication. * In second or third complete remission at the time of allogeneic transplantation * Treated with reduced intensity regimens as defined per institutional standard of practice * Lymphoid blast crisis of CML * Are relapsed or refractory to at least 1 line of chemotherapy * Philadelphia-like ALL * Patients who have \> 80% donor chimerism after allogeneic transplantation. * Philadelphia chromosome positive ALL must have failed at least 1 TKI * ECOG Performance status \< 1 * pre-transplant evaluation, see 10.1.1 * 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. * Able to adhere to the study visit schedule and other protocol requirements. * Participants must have the ability to understand and the willingness to sign a written informed consent document. Phase 1 and 2 Exclusion Criteria: * Patients with clinical 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 as defined by: * Creatinine clearance \< 30ml/min * Bilirubin \> 2X institutional upper limit of normal * AST (SGOT) \> 2X institutional upper limit of normal * ALT (SGPT) \> 2X institutional upper limit of normal * 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 VOD * Use of concomitant TKI or sirolimus * 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. * Pregnant or breastfeeding women are excluded from this study because inotuzumab ozogamicin may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with inotuzumab ozogamicin, breastfeeding should be discontinued if the mother is treated with inotuzumab ozogamicin. These potential risks may also apply to other agents used in this study. * Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy 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.) * 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.) * Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater) * 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

Treatments Being Tested

DRUG

Inotuzumab Ozogamicin

Inotuzumab ozogamicin, IV, 28 day cycles Phase 1 dosages: Dose Level -2 (0.1 mg/m\^2) Dose Level -1 (0.2 mg/m\^2) Dose Level 0 (0.3 mg/m\^2) Dose Level 1 (0.4 mg/m\^2) Dose Level 2 (0.5 mg/m\^2) Dose Level 3 (0.6 mg/m\^2)

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The University of Kansas Cancer Center
Westwood, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03104491), the sponsor (Leland Metheny), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03104491 clinical trial studying?

This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03104491?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03104491?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03104491. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03104491. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.