AzTrials
AzTrials

Leukemia, Myeloid, AcutePhase 1NCT02641002

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

A Phase 1 study testing CC-90002 in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Celgene at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CC-90002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
6 sitesUnited States
Study dates
1 Mar 2016to 18 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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, or the patient is intolerant to established therapy.
  • Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
  • Subject consents to serial bone marrow aspiration and biopsies as specified.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
  • Eligible study subjects 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60637

  • UCLA Division of Hematology Oncology

    Los Angeles, California, 90095-1752

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
CC-90002
Keywords
CC-90002, Monoclonal, Antibody, CD47, Hematologic Cancers, Acute Myeloid Leukemia, AML, Myelodysplastic syndrome, MDS, Blood disorder
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-90002Drug

    Monoclonal Ab to CD47

Study groups in NCT02641002
Study groupRoleWhat they receive
Dose escalation of CC-90002ExperimentalCC-90002 by intravenous (IV) infusion on a 28 day cycle
Receives: Drug: CC-90002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting Toxicity (DLT)

    Number of participants with a DLT

    Measured: Up to 26 months

  2. Non-tolerated Dose (NTD)

    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

    Measured: Up to 26 months

  3. Maximum tolerated dose (MTD)

    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.

    Measured: Up to 26 months

Secondary outcomes (8)

  1. Preliminary Efficacy of CC-90002

    Determined by response rates of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) by disease-appropriate response criteria.

    Measured: Up to 35 months

  2. Pharmacokinetics-Cmax

    Maximum observed concentration in serum

    Measured: Up to 35 months

  3. Pharmacokinetics-AUC

    Area under the serum concentration - time curve

    Measured: Up to 35 months

  4. Pharmacokinetics-Tmax

    Time to peak (maximum) serum concentration

    Measured: Up to 35 months

  5. Pharmacokinetics-T 1/2

    Terminal half-life (T 1/2)

    Measured: Up to 35 months

  6. Pharmacokinetics- CL

    Total body clearance of the drug from the serum

    Measured: Up to 35 months

  7. Pharmacokinetics- Vss

    Volume of distribution at steady-state

    Measured: Up to 35 months

  8. Anti-Drug Antibodies (ADAs)

    Determine the presence and frequency of anti-drug antibodies

    Measured: Up to 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study start1 Mar 2016
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Why it stopped: Preliminary monotherapy data in relapsed/refractory AML and high-risk MDS did not offer a sufficiently encouraging profile for further dose escalation/expansion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641002
Sponsor's protocol ID
CC-90002-AML-001
Status last verified
Oct 2018
First submitted
12 Nov 2015
Last updated
18 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Narla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10.

    PubMed 34247273

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-90002 in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Celgene at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Preliminary monotherapy data in relapsed/refractory AML and high-risk MDS did not offer a sufficiently encouraging profile for further dose escalation/expansion). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting Toxicity (DLT) (time frame: Up to 26 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in