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Acute Myeloid Leukemia, in RelapsePhase 2NCT05854966

CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 2 study testing CPI 613, Metformin and Blood draws in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research study is to find out what effects (the good and bad) the combination treatment of metformin and CPI-613 has in treating participants with acute myeloid leukemia or granulocytic sarcoma that has either returned after treatment or did not respond to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CPI 613, Metformin and Blood draws
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2024to Sep 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically documented relapsed and/or refractory Acute Myeloid Leukemia or granulocytic sarcoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 3.
  • Must be ≥ 18 years of age.
  • Persons of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
  • Persons who are having sexual relationships in which their partner may become pregnant must practice effective contraceptive methods during the study treatment and for 60 days after the last dose of study treatment, unless documentation of infertility exists.
  • Mentally competent, ability to understand and willingness to sign the informed consent form.
Show all 14Show fewer
  • Patients with persisting, non-hematologic, non-infectious toxicities from prior treatment must be ≤ Grade 2 and must be documented as such.
  • Laboratory values ≤ 2 weeks prior to the start of study treatment must be the following:
  • Aspartate aminotransferase [AST/SGOT] ≤ 5x upper normal limit [UNL],
  • Alanine aminotransferase [ALT/SGPT] ≤ 5x UNL
  • Bilirubin ≤ 3x UNL
  • Albumin ≥ 2.0 g/dL or ≥ 20 g/L
  • Serum creatinine ≤ 2.0 mg/dL
  • Presence of central venous catheter or willing to have central venous access placed.

Who cannot join

  • Patients with active central nervous system (CNS) or epidural tumor.
  • Pregnant persons, or persons of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
  • Breastfeeding individuals because the potential of excretion of CPI-613 into breast milk. (Note: Breastfeeding individuals are excluded because the effects of CPI-613 on a nursing child are unknown).
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patient.
  • Unwilling or unable to follow protocol requirements.
  • Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 1 week prior to initiation of CPI-613 treatment with the following exceptions:
  • The use of Hydrea or any targeted oral agent is allowed up to the day before initiation of treatment.

About this study

Official title: An Open Label, Pilot Phase II Study to Evaluate the Feasibility and Efficacy of CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

The purpose of this research study is to find out what effects (the good and bad) the combination treatment of metformin and CPI-613 has in treating participants with acute myeloid leukemia or granulocytic sarcoma that has either returned after treatment or did not respond to treatment.

Read the detailed description

Primary Objective: To establish the feasibility of delivering the combination of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML).

Secondary Objectives: To determine the response rate of CPI-613 and metformin in relapsed or refractory AML defined as Complete remission (CR) + Complete remission with incomplete count recovery (CRi) + Morphologic Leukemia-Free State (MLFS).

  • To determine the overall survival of patients with relapsed or refractory AML treated with CPI-613 and metformin.
  • To determine the safety of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML).
Being tested
CPI 613, Metformin, Blood draws, Bone marrow biopsy
Medical subject headings
Leukemia, Myeloid, Acute, Sarcoma, Myeloid

What participants receive

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

  • CPI 613Drug

    Also called Devimistat

    For INDUCTION therapy (14 day cycles): Devimistat (CPI-613) 2,500mg/m2, days 1-5, 14-day cycles for cycles 1 and 2 only.

    For MAINTENANCE therapy (21 day cycles): Devimistat (CPI-613) 2,500mg/m2, days 1-5, 21-day cycles until progression, intolerable toxicity or withdrawal of consent.

  • MetforminDrug

    Also called Metformin pill

    For INDUCTION therapy (14 day cycles):

    Metformin 500 mg daily (taken with meals), days 1-2 for cycle 1 only. Metformin 500 mg twice daily (taken with meals), days 3-14 for cycle 1 only. Metformin 1,000 mg daily (taken with meals), days 1-2 for cycle 2 only. Metformin 1,000 mg twice daily (taken with meals) days 3-4 for cycle 2 only.

    For MAINTENANCE therapy (21 day cycles): Metformin 1,000 mg twice daily (taken with meals) days 1-21 until progression, intolerable toxicity or withdrawal of consent

  • Blood drawsBiological

    In the first induction cycle ONLY, extra blood will be withdrawn on day 1 before and after treatment with CPI-613 research purposes. Additional blood draws on days 2-5 to test blood before receiving CPI-613 to make sure participants are healthy enough to receive CPI-613.

  • Bone marrow biopsyProcedure or surgery

    After the second induction cycle participants will have a bone marrow biopsy. After this biopsy, participants will have other bone marrow biopsies every 3 months for the next year. After the first year, participants may have a bone marrow biopsy if the treating physician feels it is necessary.

Study groups in NCT05854966
Study groupRoleWhat they receive
Treatment - CPI-613 with MetforminExperimentalInduction therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) for two cycles of treatment. Maintenance therapy with CPI-613 and Metformin (ideally 2 hours prior to start of CPI-613 infusions on days 1-5) until progression, intolerable toxicity of withdrawal of consent.
Receives: Drug: CPI 613; Drug: Metformin; Biological: Blood draws; Procedure: Bone marrow biopsy

What is being measured

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

  1. Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility

    Feasibility is defined as the ability to deliver at least 1 cycle of maintenance therapy in 50% or more of patients who complete induction therapy.

    Measured: After the completion of cycle 1 of maintenance therapy (maintenance cycle is 21 days)

Secondary outcomes (3)

  1. Response Rate - Efficacy (Acute Myeloid Leukemia European LeukemiaNet 2022)

    Efficacy will be assessed in the first 9 evaluable participants using a Simon's two-stage design to examine efficacy in terms of response where response is defined as:

    • Complete remission (CR) (Bone marrow blasts, 5%; absence of circulating blasts; absence of extramedullary disease; ANC ≤ 1.0 × 109/L (1,000/μL); plate) or
    • Complete remission with incomplete count recovery (CRi) (All CR criteria except for residual neutropenia < 1.0 × 109/L (1,000/μL) or thrombocytopenia < 100 × 109/L (100,000/μL) or
    • Morphologically leukemia free state (MLFS) (Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required).

    Measured: After the completion of cycle 2 (each cycle is 14 days), then every three months up to 12 months

  2. Overall Survival

    Overall survival is calculated in days from date of study treatment initiation to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: Every 3 months after last dose of study treatment, up to 2 years

  3. Number of Reported Adverse Events - Safety

    Safety will be evaluated by describing the nature and frequency of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days after last dose of study treatment

Timeline

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

  1. First posted11 May 2023
  2. Study startDec 2024 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Why it stopped: PI decided not to move forward with the study

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a Phase II, Simon's two-stage study evaluating the feasibility and effectiveness of combination CPI-613 and metformin in relapsed or refractory acute myeloid leukemia. The first stage will consist of 9 evaluable patients. If the study continues to stage 2, a total of 17 evaluable patients will be enrolled.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854966
Sponsor's protocol ID
WFBCCC 22323
Other IDs
P30CA012197
Status last verified
Sep 2024
First submitted
2 May 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPI 613, Metformin and Blood draws in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Wake Forest University Health Sciences.

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 14 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility (time frame: After the completion of cycle 1 of maintenance therapy (maintenance cycle is 21 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 NCT05854966.

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 19 Sep 2024.

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