Experimental drug aims to stop leukemia relapse after transplant
NCT ID NCT04623216
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called sabatolimab, alone or with another drug, in 24 adults and teens with acute myeloid leukemia (AML) who had signs of leftover cancer after a stem cell transplant. The goal was to see if it could prevent the cancer from coming back without causing severe side effects like graft-versus-host disease. The study was stopped early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
24 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 99 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * At the date of signing the informed consent form (ICF), eligible participants must be ≥ 18 years for the adult cohorts; and ≥ 12 years old but \< 18 years old for the adolescent cohort (cohort 5), which will open after completion of Safety Run-in. * Participants in complete remission (\< 5% bone marrow blasts, absence of circulating blasts, and absence of extramedullary disease) with MRD positivity by local assessment or by central assessment where required (e.g., USA sites), any time at ≥ Day 60 after aHSCT * Diagnosis of AML/secondary AML and received one prior aHSCT performed to control AML * Ability to provide a fresh bone marrow aspirate sample collected within 28 days from enrollment/randomization, and immediately shipped to a Novartis designated central laboratory for MRD testing. * Systemic GvHD (graft versus host disease) prophylaxis or treatment \[immunosuppressive treatment (IST)\] completely tapered for at least two weeks prior to study entry. Prednisone dose ≤ 5 mg/day or equivalent corticosteroid dose is allowed. * Participants who are found with MRD positivity while still on or tapering systemic GvHD prophylaxis or treatment, MRD positivity must be re-confirmed at least 2 week after the last dose of IST * For the adult cohorts, participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. For the adolescent cohort, participants must have a Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status score ≥ 50%. Exclusion Criteria: * Prior exposure to TIM-3 directed therapy at anytime. * History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, sabatolimab) or monoclonal antibodies (mAbs) and/or their excipients * Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Participants whose disease is controlled under antiviral therapy should not be excluded. * Active acute GvHD grade III-IV according to standard criteria (Harris 2016). * Active moderate chronic GvHD of the lungs according to NIH consensus criteria. Active severe chronic GvHD according to NIH consensus criteria. * History of another primary malignancy that is currently clinically significant or currently requires active intervention. Participants who are receiving adjuvant therapy, such as hormone therapy, are eligible * Any concurrent severe and/or active uncontrolled infection requiring parenteral antibacterial, antiviral or antifungal therapy (such as severe pneumonia, meningitis, or septicemia) * Active autoimmune disease requiring systemic therapy (e.g. corticosteroids). Topical, inhaled, nasal and ophthalmic steroids are not prohibited. Replacement corticosteroids therapy is allowed and not considered a form of systemic treatment * Live vaccine administered within 30 days prior to the first day of study treatment (Cycle 1 Day 1) * Other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes mellitus, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) or history of serious organ dysfunction or disease involving the heart, kidney, or liver
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Novartis Investigative Site
Marseille, 13273, France
-
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
-
Novartis Investigative Site
Hamburg, 20246, Germany
-
Novartis Investigative Site
Münster, 48149, Germany
-
Novartis Investigative Site
Bergamo, BG, 24127, Italy
-
Novartis Investigative Site
Bologna, BO, 40138, Italy
-
Novartis Investigative Site
Brescia, BS, 25123, Italy
-
Novartis Investigative Site
Roma, RM, 00165, Italy
-
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers