Ziftomenib Maintenance Post Allo-HCT
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT.
The name of the study drug involved in this study is:
• Ziftomenib
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Pathologically confirmed diagnosis of acute myeloid leukemia (AML).
Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.
no circulating blasts in peripheral blood and <5% blasts in bone marrow
Disqualifiers
History of other malignancy(ies) unless
the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or
the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up
the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin
Trial design
Design model
Single group
Treatments tested in this trial
Ziftomenib
DrugTaken orally once per day
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: ZiftomenibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (Dose Escalation)
Defined as the highest dose level at which 1 or 0 of 6 patients experience a Dose Limiting Toxicity (DLT). Toxicities will be graded and documented according to NCI CTCAE version 5.0. A non-hematologic DLT is any grade 3 adverse event (AE) lasting \>72 hours or any grade greater than or equal to 4 AE that is at least possibly related to the study drug with exceptions. Any ≥ grade 2 non-hematologic toxicity that the participant finds intolerable or renders the participant unable to take 75% or more of the assigned doses (e.g. multiple dose interruptions) during the first cycle will be considered a DLT.
Time frame
28 daysSecondary outcomes
1
Occurrence of ziftomenib-related toxicities
Defined as ziftomenib-related toxicities detected and categorized according to severity. Toxicities will be graded and documented according to NCI CTCAE version 5.0.
Time frame
Day 0 to last treatment dose, up to 336 days2
Incidence of acute Graft versus Host Disease (GVHD) during treatment
Defined as cumulative incidence of acute GVHD from start of ziftomenib in subjects receiving maintenance therapy after allogeneic HCT. Clinical stage and grade of acute graft-versus-host-disease (GVHD) is based on MAGIC Criteria (Harris 2016). The incidence of acute GVHD grade II-IV and grade III-IV will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to acute GVHD as a competing event.
Time frame
Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment)3
Incidence of chronic Graft versus Host Disease (GVHD) during treatment
The incidence of chronic GVHD will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to chronic GVHD as a competing event. Chronic GVHD will be assessed as per the 2014 National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease (Jagasia 2015).
Time frame
Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment)4
Non-relapse mortality (NRM)
The incidence of non-relapse mortality will be estimated for each treatment group using the cumulative incidence estimate, treating disease relapse or progression as a competing event. AML treatment response is based on 2022 ELN recommendations (Dohner 2022).
Time frame
Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up))Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov