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Acute Myeloid LeukemiaPhase 2NCT02282215

Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia

A Phase 2 study testing CLT-008 and G-CSF in people with Acute Myeloid Leukemia and Neutropenia, run by Cellerant Therapeutics at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Acute Myeloid Leukemia, Neutropenia, Infection
What is being tested?
CLT-008 and G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
22 sitesUnited States
Study dates
Dec 2014to 22 Sep 2017
Phase
Phase 2
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute myeloid leukemia arising de novo (per European LeukemiaNet)
  • Treated with any established chemotherapy regimen based on either:
  • 7+3: Standard-dose cytarabine 100-200 mg per meter squared continuous infusion for 7 days with idarubicin 12 mg per meter squared or daunorubicin 45-90 mg per meter squared for 3 days
  • High-dose cytarabine-based (HIDAC) chemotherapy administering a total cytarabine dose of ≥ 4 g per meter squared alone or in combination with other anti-leukemic agents (for example, anthracyclines, purine nucleoside inhibitors, etoposide, etc.)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening or by the day chemotherapy is initiated
  • Adequate respiratory function with a room air oxygen saturation of at least 92%
Show all 12Show fewer
  • Adequate cardiac function defined as an ejection fraction of at least 45%
  • Serum bilirubin ≤ 1.5 times the upper limits of normal. Subjects with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of > 1.5 mg/dL
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limits of normal prior to chemotherapy
  • Serum creatinine ≤ 2 times upper limits of normal or estimated glomerular filtration rate ≥ 60 mL/min/1.73 meter squared per Modification of Diet in Renal Disease equation (MDRD)
  • All subjects, except post-menopausal women, must be willing to utilize a highly effective method of contraception throughout the study
  • Adequately informed of the nature and risks of the study with written informed consent

Who cannot join

  • Pregnant or breast feeding
  • Overt central nervous system manifestations of leukemia at diagnosis
  • Specifically diagnosed and uncontrolled fungal, bacterial, viral, or other infection (e.g. confirmed sepsis, pneumonia, abscess, cellulitis, etc.) at the day chemotherapy is initiated. "Uncontrolled" is defined as exhibiting ongoing signs and symptoms of infection without improvement despite antimicrobial or other treatment.
  • AML subtype M3 (promyelocytic leukemia)
  • Previous chemotherapy for AML
  • History of or current human immunodeficiency virus (HIV) or hepatitis C virus infection
Show all 12Show fewer
  • History of or current clinically significant immunodeficiency
  • Known contraindication to receiving G-CSF
  • History of or current clinically significant alloimmunization to leukocyte antigens
  • Participation in another clinical study within 28 days of the day chemotherapy is initiated, in which the study drug or device may influence hematopoiesis. Co-enrollment in another study is allowed in cases where the investigational therapy under study is a version of an acceptable chemotherapy regimen for this study per the inclusion criteria.
  • Receiving any agent concurrently with CLT-008 infusion which inhibits cell division (e.g., methotrexate or hydroxyurea)
  • Acute or chronic medical disorder that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • The University of Chicago

    Chicago, Illinois, 60637

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Blood and Marrow Transplantation Clinic

    Indianapolis, Indiana, 46237

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Minnesota Physicians BMT Clinic

    Minneapolis, Minnesota, 55455

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 66215

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Westchester Medical Center

    Valhalla, New York, 10595

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: An Open-Label Phase 2 Prospective, Randomized, Controlled Study of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia

The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).

Read the detailed description

The prolonged period of severe neutropenia caused by induction chemotherapy for the treatment of AML is associated with a nearly universal risk of febrile neutropenia. Standard supportive care strategies include administration of prophylactic anti-bacterial and anti-fungal agents, but serious breakthrough bacterial and fungal infections still occur. Granulocyte colony-stimulating factor (G-CSF; filgrastim, Neupogen®) has been shown to shorten the duration of severe neutropenia, fever, antibiotic use and hospitalization following induction chemotherapy for AML. CLT-008, a human allogeneic myeloid progenitor cell product, is intended to provide the cellular target for G-CSF to produce neutrophils during the period of chemotherapy-induced bone marrow suppression when the patient's own progenitor cells may be limited in responding to G-CSF. It is hypothesized that the production of allogeneic neutrophils from CLT-008 will be sufficient to mitigate the infection-related consequences of induction chemotherapy for AML.

Being tested
CLT-008, G-CSF
Keywords
Fever, Induction chemotherapy, Infection, Leukemia, Myeloid progenitor cells, Neutropenia
Medical subject headings
Leukemia, Myeloid, Acute, Neutropenia, Infections, Fever, Leukemia

What participants receive

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

  • CLT-008Biological

    Also called human allogeneic myeloid progenitor cells (hMPC), romyelocel-L

    Single intravenous infusion

  • G-CSFBiological

    Also called Neupogen (filgrastim), granulocyte colony-stimulating factor, Zarxio, Granix (tbo-filgrastim)

    Daily subcutaneous injections

Study groups in NCT02282215
Study groupRoleWhat they receive
CLT-008 low dose with G-CSFExperimentalDose escalation
Receives: Biological: CLT-008; Biological: G-CSF
CLT-008 high dose with G-CSFExperimentalDose escalation
Receives: Biological: CLT-008; Biological: G-CSF
CLT-008 with G-CSFExperimentalRandomized
Receives: Biological: CLT-008; Biological: G-CSF
G-CSFActive comparatorRandomized
Receives: Biological: G-CSF

What is being measured

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

  1. Duration of febrile episodes (fever)

    Measured: 42 days

Secondary outcomes (8)

  1. Time to absolute neutrophil count (ANC) recovery

    Measured: 42 days

  2. Incidence and duration of febrile neutropenia

    Measured: 42 days

  3. Incidence and duration of infection

    Measured: 42 days

  4. Incidence and severity of mucositis

    Measured: 42 days

  5. Incidence of infusion reactions

    Measured: 42 days

  6. Incidence of Graft-versus-Host Disease (GVHD)

    Measured: 42 days

  7. Incidence of Adverse Events (AE)

    Measured: 42 days

  8. Incidence of Serious Adverse Events (SAE)

    Measured: 42 days

Timeline

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

  1. First posted4 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion22 Sep 2017
  4. Study completion22 Sep 2017

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282215
Sponsor's protocol ID
CLT008-03
Status last verified
Sep 2018
First submitted
31 Oct 2014
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Desai PM, Brown J, Gill S, Solh MM, Akard LP, Hsu JW, Ustun C, Andreadis C, Frankfurt O, Foran JM, Lister J, Schiller GJ, Wieduwilt MJ, Pagel JM, Stiff PJ, Liu D, Khan I, Stock W, Kambhampati S, Tallman MS, Morris L, Edwards J, Pusic I, Kantarjian HM, Mamelok R, Wong A, Van Syoc R, Kellerman L, Panuganti S, Mandalam R, Abboud CN, Ravandi F. Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia. J Clin Oncol. 2021 Oct 10;39(29):3261-3272. doi: 10.1200/JCO.20.01739. Epub 2021 Jun 22.

    PubMed 34156898

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLT-008 and G-CSF in people with Acute Myeloid Leukemia and Neutropenia, run by Cellerant Therapeutics at 22 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Duration of febrile episodes (fever) (time frame: 42 days). 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 NCT02282215, 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 27 Sep 2018.

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