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Acute Myeloid LeukemiaPhase 2NCT04254640

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

A Phase 2 study testing Cladribine Injection, Aclarubicin and G-CSF in people with Acute Myeloid Leukemia and Elderly Patients, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in elderly patients with AML. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Cladribine Injection, Aclarubicin and G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 Mar 2021to 31 Dec 2023
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with:
  • a diagnosis of AML according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML
  • Patients 60 years and older.
  • Patients NOT eligible for standard chemotherapy, defined as hematopoietic cell transplantation comorbidity index (HCT-CI) ≥ 3 or Patients NOT eligible for standard chemotherapy for other reasons (wish of patient).
  • White blood cell (WBC) ≤ 10 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2 days before start cladribine treatment)
  • Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
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  • Serum creatinine ≤ 221.7 µmol/L (≤ 2.5 mg/dL ), unless considered AML-related -Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML-
  • related or due to Gilbert's syndrome
  • Alanine transaminase (ALT) ≤ 2.5 x ULN, unless considered AML-related
  • WHO performance status 0, 1 or 2.
  • Patient is willing and able to use adequate contraception during and until 5 months after the last protocol treatment.
  • Written informed consent.
  • Patient is capable of giving informed consent.

Who cannot join

  • Acute promyelocytic leukemia.
  • Acute leukemia's of ambiguous lineage according to WHO 2016
  • Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
  • Blast crisis of chronic myeloid leukemia.
  • Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
  • except when the patient completed successfully treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization. OR
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  • except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period ( ≤ 5 days) with Hydroxyurea is allowed
  • Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
  • Cardiac dysfunction as defined by:
  • Myocardial infarction within the last 3 months of study entry, or
  • Reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram or
  • Unstable angina or
  • New York Heart Association grade IV congestive heart failure or
  • Unstable cardiac arrhythmias.
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
  • Patient has a history of human immunodeficiency virus or active infection with Hepatitis C or B.
  • Patients known to be pregnant
  • Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.
  • Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
  • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Trial locations and contacts

1 site in 1 country.

wang hua, MD. contact

0086-02087342462

wanghua@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    hua wang, MD., 0086-02087342462, wanghua@sysucc.org.cn

Other trials in China

About this study

Official title: Efficacy and Safety of Cladribine in Combination With G-CSF,Low-dose Cytarabine and Aclarubicin in Newly Diagnosed Unfit Patients With Acute Myeloid Leukemia

In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in elderly patients with AML.

Read the detailed description

The low-intensity chemotherapy were developed to reduce the early mortality and improve the benefit-risk ratio for longterm survival in elderly or unfit AML patients.Previous studies revealed that the standard dose of CAG regimen consisting of low-dose cytarabine and aclarubicin in combination with granulocyte colonystimulating factor (G-CSF) priming as an induction therapy was well-tolerated by patients and led to a complete remission (CR) rate of 50.0% in patients aged≥ 70 years. Cladribine (2-chlorodeoxyadenosine ) is a nucleoside analogue of anti-adenosine deaminase that has extensive antitumor activity in hematological tumor.The purine analog 2-CdA increases the uptake of Ara-C and the accumulation of its active cytotoxic metabolite 5α-triphosphate Ara-C (Ara-CTP) in leukemia cells. This finding suggests that synergy occurs between cladribine and cytarabine. In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in unfit patients with AML.Patients will receive C-CAG regimen as follows: cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle. The participants are permitted to quit the study if complete remission (CR) was not achieved after two courses of chemotherapy.The participants will be treated for a total of six cycles unless disease progression or unacceptable side effects are observed or participants withdrew their consent.

Being tested
Cladribine Injection, Aclarubicin, G-CSF, cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • Cladribine InjectionDrug

    Also called 2-chlorodeoxyadenosine

    Cladribine 5 mg/m2, intravenous drip,d1-5,4 weeks per cycle.

  • AclarubicinDrug

    Also called aclarubicin hydrochloride

    aclarubicin 10 mg, intravenous drip,d3-6,4 weeks per cycle.

  • G-CSFDrug

    Also called Granulocyte Colony-Stimulating Factor

    G-CSF 300 µg,subcutaneous injection, d0-9,4 weeks per cycle.

  • cytarabineDrug

    Also called cytarabine hydrochloride

    cytarabine 10mg/ m2, subcutaneous injectionq,q12h, d3-9,4 weeks per cycle.

Study groups in NCT04254640
Study groupRoleWhat they receive
C-CAGExperimentalcladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle.
Receives: Drug: Cladribine Injection; Drug: Aclarubicin; Drug: G-CSF; Drug: cytarabine

What is being measured

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

  1. Cumulative Complete Remission (CR) / CR with incomplete blood count (CRi) rate

    Cumulative CR/CRi rate during 2 cycles

    Measured: At the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes (4)

  1. Safety and tolerability of Cladribine in Combination With CAG determined by the type, frequency, severity and relationship of adverse events to study treatment

    Safety and tolerability of Cladribine in Combination With treatment for CAG for AML (type, frequency, severity and relationship of adverse events to study treatment).

    Measured: 1 years

  2. Event free survival (EFS)

    The time from registration to induction failure, death or relapse whichever occurs first

    Measured: 5 years

  3. Overall survival (OS)

    The time from the date of registration to the date of death, whatever the cause. Patients still alive at the date last contact will be censored.

    Measured: 5 years

  4. Prognostic value of MRD

    Assessment of the prognostic value of Minimal Residual Disease (MRD) by flowcytometry or PCR

    Measured: 9 months and at relapse

Timeline

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

  1. First posted5 Feb 2020
  2. Study start1 Mar 2021 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

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
cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04254640
Sponsor's protocol ID
AML-2020
Status last verified
Jan 2020
First submitted
20 Jan 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cladribine Injection, Aclarubicin and G-CSF in people with Acute Myeloid Leukemia and Elderly Patients, run by Sun Yat-sen University at 1 site in China.

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 13 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

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

Contact wang hua, MD. (0086-02087342462, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Complete Remission (CR) / CR with incomplete blood count (CRi) rate (time frame: At the end of Cycle 2 (each cycle is 28 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 NCT04254640.

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 17 Dec 2020.

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