CompletedPhase 2

An Open-label Phase II Study of Lorvotuzumab Mertansine

United States9 participantsStarted 2015-05-12

Plain-language summary

The goal of this clinical research study is to learn if lorvotuzumab mertansine can help to control blood cancers that have the CD56 tumor marker. The safety of this drug will also be studied.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with CD56 expressing hematological malignancy, as follows: Cohort 1: CD56 expressing hematological malignancies including but not limited to AML, high-risk myelodysplastic syndrome (MDS), natural-killer leukemia, acute lymphoblastic leukemia, accelerated and blast-phase chronic myelocytic leukemia (CML) who have failed prior therapy or for which no standard therapy exists.Cohort 2: Patients with MF (either primary MF, post-polycythemia MF, or post-essential thrombocythemia MF) and CD56 expression who have been on ruxolitinib or JAK-inhibitor therapy for at least 12 weeks and deemed refractory or sub-optimal responders in the opinion of the treating physician.Cohort 3: Patients with pathological diagnosis of BPDCN with CD56 expression (frontline and relapsed/refractory).
✓. Any level of CD56 expression will be considered sufficient for enrollment on this study.
✓. Prior therapy with hydroxyurea, chemotherapy, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed.
✓. Age \>/=18 years
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status \</= 2
✓. Adequate organ function: total bilirubin \</= 2 times upper limit of normal (x ULN) (\</=3 x ULN if considered to be due to leukemic involvement or Gilbert's syndrome); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 2.5 x ULN (\</= 5.0 x ULN if considered to be due to leukemic involvement); serum creatinine \</= 2 x ULN, amylase and lipase \</=2 x ULN .
✓. In the absence of rapidly progressing disease and after discussion with the Principal Investigator (PI), the interval from prior treatment to time of IMGN901 administration will be at least 2 weeks or at least 5 half-lives for cytotoxic/noncytotoxic agents. The half-life be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document.
✓. continuation from criteria #7: For prior monoclonal antibody therapy the interval from prior monoclonal antibody treatment to time of IMGN901 administration will be at least 2 weeks. The use of chemotherapeutic or anti-leukemic agents other than hydroxyurea (as defined in the protocol) is not permitted during the study with the exception of intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the PI. Hydroxyurea is allowed prior to the initiation of IMGN901 and during the first 3 cycles, either prior to or concomitantly with IMGN901 administration initially to control Leukocytosis.

Exclusion criteria

✕. Patients with known allergy or hypersensitivity to IMGN901.
✕. Patients who have previously been treated with IMGN901.
✕. Patients with symptomatic central nervous system (CNS) leukemia or patients with poorly controlled central nervous system leukemia.
✕. Peripheral neuropathy \>grade 2.
✕. Active or clinically symptomatic chronic pancreatitis or disease affecting pancreas.
✕. Neurologic disease including multiple sclerosis, Eaton-Lambert syndrome, demyelination.
✕. Significant cardiac disease including myocardial infarction or unstable angina within 6 months, uncontrolled hypertension despite medical therapy (defined as blood pressure \>160/110 in spite of adequate medical therapy), active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, stroke within preceding 6 months.
✕. Patients with known Human Immunodeficiency Virus seropositivity will be excluded.

What they're measuring

Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies

Timeframe: 53 days

Trial details

NCT IDNCT02420873

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-06

Results submitted2018-05-03

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