A Study of the Safety, Tolerability, and Treatment Dosage of CC-90002 for Subjects with Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-008009
    NCT ID: NCT02641002
    Sponsor Protocol Number: CC-90002-AML-001

About this study

The purpose of this study explore the safety and tolerability of increasing doses of CC-90002, to find the best dose for subjects with relapsed and/or primary refractory Acute Myeloid Leukemia (AML) and high-risk Myelodisplastic Syndrome (MDS).

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Men and women
  • ≥ 18 years of age, at the time of signing the informed consent form (ICF)
  • Relapsed and/or primary refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with subtype refractory anemia with excess blasts (RAEB)-2 defined as high or very high-risk that is recurrent or refractory
  • Intolerant to established therapy
  • Consent for hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after
  • Consent to serial bone marrow aspiration and biopsies as specified
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
  • Must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests
  • Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and for up to 8 weeks following the last dose of CC 90002

Exclusion Criteria:

  • Active central nervous system (CNS) leukemia or known CNS leukemia
  • Immediately life-threatening, severe complications of leukemia
  • Impaired cardiac function or clinically significant cardiac diseases
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Prior autologous hematopoietic stem cell transplant ≤ 3 months
  • Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months
  • Systemic immunosuppressive therapy post HSCT or with clinically significant graft-versus-host disease (GVHD)
  • Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks whichever is shorter
  • Major surgery ≤ 2 weeks and recovered from any clinically significant effects of recent surgery
  • Pregnant or nursing females
  • Known HIV infection
  • Known chronic hepatitis B or C (HBV/HCV) infection
  • Ongoing treatment with chronic, therapeutic dosing of anti-coagulants
  • History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • History of concurrent second cancers requiring active, ongoing systemic treatment
  • Subjects for whom potentially curative anticancer therapy is available

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20209356

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