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

NCT04254640 | Unknown Phase 2 DMC

• 1 other identifier: AML-2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia; Elderly Patients; Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

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

  Cumulative CR/CRi rate during 2 cycles

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

Secondary Outcomes (4)

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

  1 years

• Event free survival (EFS)

  5 years

• Overall survival (OS)

  5 years

• Prognostic value of MRD

  9 months and at relapse

Study Arms (1)

C-CAG

EXPERIMENTAL

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.

Drug: Cladribine Injection; Drug: Aclarubicin; Drug: G-CSF; Drug: cytarabine

Interventions

Cladribine Injection DRUG

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

Also known as: 2-chlorodeoxyadenosine

C-CAG

Aclarubicin DRUG

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

Also known as: aclarubicin hydrochloride

C-CAG

G-CSF DRUG

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

Also known as: Granulocyte Colony-Stimulating Factor

C-CAG

cytarabine DRUG

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

Also known as: cytarabine hydrochloride

C-CAG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cladribine; Aclarubicin; Granulocyte Colony-Stimulating Factor; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides

Study Officials

• wang hua, MD.

  sun yat-sun university cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wang hua, MD.

CONTACT

0086-02087342462; wanghua@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of hematology, Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2020

Record last verified: 2020-01

Locations

CN (1)