Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02641002
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02641002
Study Brief:
Protocol Section:
NCT02641002