Health TrialsbyHealthPanel

Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

ConditionsAcute LeukemiaAcute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChildhood Acute LeukemiaChildhood Acute Leukemia of Ambiguous LineageChildhood Acute Lymphoblastic LeukemiaChildhood Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2+
SponsorCity of Hope Medical Center

About this trial

This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PATIENTS WHO ARE SCHEDULED TO UNDERGO HEMATOPOIETIC CELL TRANSPLANTATION (HCT) OR THOSE WHO HAVE UNDERGONE HCT: Documented informed consent of the participant and/or legally authorized representative

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Agreement to allow the use of archival tissue from diagnostic tumor biopsies; if unavailable, exceptions may be granted with study principal investigator (PI) approval

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participant is willing and able to adhere to the study visit schedule and other protocol requirements

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Age: >= 2 years

Disqualifiers

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Prior diagnosis of acute promyelocytic leukemia

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Participants who are unable to take a strong CYP3A4 inhibitor such as voriconazole or posaconazole. Note: Patients must be taking a strong CYP3A4 inhibiting antifungal at least 7 days prior to starting revumenib cycle 1

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: Patients requiring the concurrent use of medications known or suspected to prolong the QT/corrected QT (QTc) interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard supportive therapies (e.g., diphenhydramine, famotidine, ondansetron, bactrim, tacrolimus, azoles)

PATIENTS WHO ARE SCHEDULED TO UNDERGO HCT OR THOSE WHO HAVE UNDERGONE HCT: History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that in the investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Revumenib

    Drug

    Given PO

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Treatment (revumenib)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Will evaluate toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, including dose limiting toxicity (DLT). The toxicity/adverse event information recorded on each subject will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limited to infections, other adverse events of special interest, and serious adverse events.

Time frame
Start of protocol therapy up to 2 years

Secondary outcomes

1

Molecular response

Will evaluate molecular response using quantitative polymerase chain reaction for NPM1 mutated acute myeloid leukemia and ClonoSeq for B-acute lymphoblastic leukemia, per standard of care.

Time frame
Up to 2 years
2

Overall survival (OS)

OS will be censored at last follow-up if patients are known to be alive. Survival endpoints will be analyzed using Kaplan-Meier curves.

Time frame
Start of protocol therapy to death, assessed up to 2 years
3

Relapse free survival (RFS)

RFS will be censored at last follow-up if patients are alive and relapse/progression-free. Survival endpoints will be analyzed using Kaplan-Meier curves.

Time frame
Start of protocol therapy to relapse/progression or death, assessed up to 2 years
4

Graft versus host disease (GVHD)-free/relapse survival (GRFS)

GRFS will be censored at last follow-up if patients are known to be alive and free of any event of interest. Survival endpoints will be analyzed using Kaplan-Meier curves.

Time frame
Start of protocol therapy to first observation of developing grade 3-4 acute GVHD, chronic GVHD requiring systemic therapy, relapse/progression, or death, assessed up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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