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Inotuzumab Ozogamicin After Transplant for Acute Lymphocytic Leukemia

This study is testing Inotuzumab Ozogamicin in patients with Acute Lymphocytic Leukemia (ALL) who have recently had a stem cell transplant. Inotuzumab Ozogamicin is a combination of an antibody and chemotherapy. The study aims to find a safe dose (Phase I) and then see how well it prevents ALL from coming back (Phase II). You may be able to join if you are between 16 and 75 years old, have CD22-positive ALL, and received an allogeneic (from a donor) stem cell transplant between 40 and 100 days ago. The study will look at how long patients live without their disease returning.

Study design
This is a Phase I/II study with an estimated 44 participants. Phase I will determine the safest dose, followed by Phase II to assess effectiveness.
What's involved
Participants will receive Inotuzumab Ozogamicin intravenously (IV) in 28-day cycles, for up to 4 cycles. Safety and tolerability will be continuously monitored through clinical and laboratory assessments.
Compensation
Not stated in the trial record.
Follow-up
The study will assess disease-free survival at 3 months after initial treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03104491

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

Recruiting
PHASE1Ages 16–75InterventionalTreatment
Leland Metheny
~44 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:Inotuzumab Ozogamicin

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I MTD
Measured over Up to 112 days (16 weeks)
+6 more outcomes measured

Conditions

Acute Lymphocytic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaCD22 Gene

NCT03104491

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohiono site contact published

    Recruiting

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohiono site contact published

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkno site contact published

    Active, not recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansasno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Leland Metheny, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Leland Metheny, MD
[email protected]
1-800-641-2422
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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

What this trial measures

  • Phase I MTDUp to 112 days (16 weeks)

    Defined post hematopoietic stem cell transplantation MTD

  • Phase I DLTsUp to 112 days (16 weeks)

    Frequency of DLTs during the first two cycles in ALL-participants

  • Phase II Median DFSAt 3 months after initial treatment

    Efficacy as measured by phase II 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 first dose 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)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested

  • Phase II Median DFSAt 6 months after initial treatment

    Efficacy as measured by phase II 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 first dose 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)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested

  • Phase II Median DFSAt 9 months after initial treatment

    Efficacy as measured by phase II 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 first dose 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)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested

  • Phase II Median DFSAt 1 year after initial treatment

    Efficacy as measured by phase II 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 first dose 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)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested

  • Phase II Median DFSPost first dose of inotuzumab ozogamicin

    Efficacy as measured by phase II 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 first dose 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)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested