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About
The investigators hypothesize that flotetuzumab for relapsed AML following allo-HCT will be safe, tolerable and may facilitate preferential immune effector cell retargeting of leukemic cells resulting in improved patient outcomes. Furthermore, administration of a donor lymphocyte infusion (DLI) (if available) in combination with flotetuzumab will be safe, tolerable and may provide additional therapeutic efficacy.
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Inclusion and exclusion criteria
Recipient Inclusion Criteria:
Histologically or cytologically confirmed relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), including any AML subtype, except acute promyelocytic leukemia (APL), and including AML that has evolved from a previous MDS or MPN.
Patients must have peripheral blast count ≤ 20,000/mm3. Use of hydroxyurea to control blast count is permitted.
Patients must be status post allo-HCT (including: matched related, matched unrelated, haploidentical, mismatched unrelated; and cord blood HCT).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Adequate organ function, defined as:
Recovery from toxicities of clinical consequence attributed to previous chemotherapy to CTCAE v4.0 Grade ≤ 1 (i.e., certain toxicities such as alopecia will not be considered in this category).
Female patients of childbearing potential must test negative for pregnancy at enrollment and during the study. Sexually active women of child-bearing potential, unless surgically sterile, must be willing to use a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs) or vasectomized partner. Male patients with partners of childbearing potential must be either vasectomized or agree to use a condom in addition to having their partners use another method of contraception resulting in a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, or IUDs. Patients should not have sexual intercourse with females who are either pregnant or lactating without a condom. Contraception should be employed from the time of consent through 12 weeks after MGD006 administration. Patients should also abstain from sperm/egg donation during the course of the study.
Able to have corticosteroids weaned to ≤0.5mg/kg prednisone/day (or equivalent)
Able to have non-steroidal immunosuppression discontinued, including:
mycophenolate (MMF)
calcineurin inhibitors (tacrolimus, cyclosporine)
**calcineurin inhibitors must be able to be discontinued at least 14 days prior to enrolling on study.
JAK inhibitors (ruxolitinib)
MTOR inhibitors (sirolimus)
At least 18 years of age.
Ability to understand and willingness to sign an IRB approved written informed consent document
Recipient Exclusion Criteria:
Active GVHD requiring systemic immunosuppresion with more than 0.5 mg/day prednisone
Currently receiving any other investigational agents.
Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation).
Second primary malignancy that requires active therapy (adjuvant hormonal therapy is allowed).
Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular- targeted therapy, retinoid therapy, or investigational agent) within 5 half-lives of Cycle 1 Day 1
At the time of study entry, steroids >0.5mg/kg of prednisone or equivalent (except steroid inhaler, nasal spray or ophthalmic solution which are allowed).
Use of immunosuppressant medications (other than steroids as noted) in the 2 weeks prior to study drug administration (Cycle 1 Day 1).
Isolated extramedullary relapse (i.e., no evidence of bone marrow involvement).
Known central nervous system (CNS) leukemia. Patients with suspected CNS leukemia must be evaluated by lumbar puncture and be free of CNS disease prior to study entry. Previously treated CNS leukemia is allowed provided adequate treatment has been provided and the patient is free of CNS disease.
Any medical or psychiatric condition limiting full compliance or increasing the safety risk, at the discretion of the PI, such as:
Known hypersensitivity to murine, yeast, or recombinant proteins; polysorbate 80; recombinant human serum albumin; benzyl alcohol; or any excipient contained in the MGD006 drug formulation.
Dementia or altered mental status that would preclude sufficient understanding to provide informed consent.
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Central trial contact
Matthew Christopher, M.D., Ph.D.
Data sourced from clinicaltrials.gov
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