ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641002
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

November 12, 2015
December 29, 2015
August 20, 2018
March 1, 2016
July 10, 2019   (Final data collection date for primary outcome measure)
  • Dose-limiting Toxicity (DLT) [ Time Frame: Up to 26 months ]
    Number of participants with a DLT
  • Non-tolerated Dose (NTD) [ Time Frame: Up to 26 months ]
    The NTD is defined as the dose at which 2 or more of up to 6 evaluable subjects in a cohort experience a DLT in Cycle 1
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 26 months ]
    The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.
Same as current
Complete list of historical versions of study NCT02641002 on ClinicalTrials.gov Archive Site
  • Preliminary Efficacy of CC-90002 [ Time Frame: Up to 35 months ]
    Determined by response rates of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) by disease-appropriate response criteria.
  • Pharmacokinetics-Cmax [ Time Frame: Up to 35 months ]
    Maximum observed concentration in serum
  • Pharmacokinetics-AUC [ Time Frame: Up to 35 months ]
    Area under the serum concentration - time curve
  • Pharmacokinetics-Tmax [ Time Frame: Up to 35 months ]
    Time to peak (maximum) serum concentration
  • Pharmacokinetics-T 1/2 [ Time Frame: Up to 35 months ]
    Terminal half-life (T 1/2)
  • Pharmacokinetics- CL [ Time Frame: Up to 35 months ]
    Total body clearance of the drug from the serum
  • Pharmacokinetics- Vss [ Time Frame: Up to 35 months ]
    Volume of distribution at steady-state
  • Anti-Drug Antibodies (ADAs) [ Time Frame: Up to 35 months ]
    Determine the presence and frequency of anti-drug antibodies
Same as current
Not Provided
Not Provided
 
A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
A Phase 1, Open-label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Acute Myeloid Leukemia and High-Risk Myelodsplastic Syndrome

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.

In both Part A and Part B, treatments will be administered in two phases starting with an induction phase followed by a maintenance phase. During the induction phase, treatments will be administered in 42-day cycles in Cycles 1 through 4. Following completion of Cycle 4 in the induction phase, subjects with non-progressive disease will enter the maintenance phase. During the maintenance phase, treatments will be administered in 28 day cycles. Subjects may continue CC-90002 for up to a maximum of 2 years (eg, induction phase Cycles 1 through 4 and maintenance phase Cycles 5 through 24) or until clinically significant disease progression, the occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90002, whichever comes first.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
Drug: CC-90002
Monoclonal Ab to CD47
Experimental: Dose escalation of CC-90002
CC-90002 by intravenous (IV) infusion on a 28 day cycle
Intervention: Drug: CC-90002
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
71
78
July 10, 2019
July 10, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
United States
 
 
NCT02641002
CC-90002-AML-001
No
Not Provided
Not Provided
Celgene
Celgene
Not Provided
Study Director: Michael Burgess, MD, PhD Celgene Corporation
Celgene
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP