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Clinical Trial 20082

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03728335

Phase: N/A
Prinicipal Investigator:

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Overview

Study Title

Pilot Trial of Enasidenib Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients with IDH2 Mutation

Summary

This phase I trial studies the side effects of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Objective

Primary Objective Evaluate the safety and tolerability of Enasidenib as post HCT maintenance therapy in patients with IDH2+ AML. Secondary Objective Assess overall and leukemia free survival in patients post allogeneic HCT; and Estimate relapse incidence, non-relapse mortality, GVHD and relapse free survival (GRFS) in patients receiving Enasidenib maintenance therapy.

Treatments

Therapies

Medications

Enasidenib ()

Inclusion Criteria

Inclusion Criteria:

  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Eastern Cooperative Oncology Group (ECOG) == 70
  • Recipients of allogeneic HCT - all stem cell sources including sibling, unrelated, mismatched related/unrelated, cord and haploidentical transplant patients will be included Conditioning regimen: Investigator's choice based on center guidelines
  • GvHD prophylaxis: sirolimus + tacrolimus or tacrolimus + methotrexate or investigator choice
  • Patients must have acute myeloid leukemia (AML) with IDH2 mutation at diagnosis. Day 30 marrow post HCT should show evidence of morphologic remission with > Patients with previous therapy with IDH2 inhibitors will be included’
  • Adequate organ function
  • Seronegative for human immunodeficiency virus (HIV) antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin [RPR]). If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

  • Exclusion Criteria

    Exclusion Criteria:

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  • Active diarrhea considered clinically significant and may impair oral drug administration
  • Clinically significant uncontrolled illness
  • Active infection requiring antibiotics. Patients with treated viral, bacterial or fungal infections that are controlled on therapy will be allowed to participate
  • Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  • Diagnosis of Gilbert's disease
  • Other active malignancy. Participants with history of prior malignancy treated with curative intent who achieved complete response (CR) more than 2 years before study entry are eligible. This exclusion rule does not apply to non‐melanoma skin tumors and in‐situ cervical cancer
  • Females only: Pregnant or breastfeeding
  • Active grade II‐IV acute GVHD and/or requiring systemic steroids with prednisone dose equivalent of >= 0.25 mg/kg at end of 4 weeks
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants, who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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