A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)

Overview

About this study

Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Men and women ≥ 18 years of age, at the time of signing the informed consent form (ICF).
  2. 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, or the patient is intolerant to established therapy.
  3. Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
  4. Subject consents to serial bone marrow aspiration and biopsies as specified.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
  6. Eligible study subjects must exhibit acceptable liver, renal, and coagulation function as assessed by laboratory tests.
  7. 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:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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