TerminatedPhase 2

Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia

Stopped: Closed due to slow accrual

United States5 participantsStarted 2019-05-14

Plain-language summary

This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients. Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL. Primary Objective * Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL with 0.1 - 4.99% blasts in bone marrow. Secondary Objectives * Study the safety of inotuzumab ozogamicin when used in patients with MRD - positive CD22+ B-ALL with \< 5 % blasts in bone marrow. * Estimate the incidence, severity, and outcome of hepatotoxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in patients during inotuzumab ozogamicin and following subsequent treatment, including hematopoietic stem cell transplant (HSCT).

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age * Participants must be \< 22 years of age. Diagnosis * Participants must have B-ALL with persistent or rising MRD between 0.1 and 4.99% without extramedullary disease following at least two prior induction attempts, relapse or after hematopoietic stem cell transplant * Leukemia blasts demonstrating surface expression of CD22 Performance Level * Karnofsky or Lansky performance score ≥ 50% (corresponding to ECOG Score of ≥ 2). The Lansky performance score should be used for participants \< 16 years and the Karnofsky performance score for participants ≥ 16 years. Prior Therapy * Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. * At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids. * At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur. * At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab. Patients must have been off blinatumomab infusion for at least 7 days and all drug rela…

What they're measuring

Treatment response Cycle1 - count

Timeframe: At the end of cycle 1 (each cycle is 28 days)

Treatment Response Cycle 1 - percentage

Timeframe: At the end of cycle 1 (each cycle is 28 days)

Treatment Response Cycle 2 - count

Timeframe: At the end of cycle 2 (each cycle is 28 days)

Treatment Response Cycle 2 - percentage

Timeframe: At the end of cycle 2 (each cycle is 28 days)

Trial details

NCT IDNCT03913559

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Plain-language summary

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment response Cycle1 - count

Timeframe: At the end of cycle 1 (each cycle is 28 days)

Treatment Response Cycle 1 - percentage

Timeframe: At the end of cycle 1 (each cycle is 28 days)

Treatment Response Cycle 2 - count

Timeframe: At the end of cycle 2 (each cycle is 28 days)

Treatment Response Cycle 2 - percentage

Timeframe: At the end of cycle 2 (each cycle is 28 days)