Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT05906914

Terminé

CHA: Cladribine Plus Homoharringtonine and Cytarabine Regimen (CHA) for de Novo Acute Myeloid Leukemia

Interventionnel

Phase 2

The First Affiliated Hospital, Zhejiang University School of Medicine

Sponsor: First Affiliated Hospital of Zhejiang University

Dernière synchronisation : 7 mai 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

The goal of this clinical trial is to evaluate the response and safety of Cladribine plus Homoharringtonine and Cytarabine regimen (CHA) protocol in de novo acute myeloid leukemia with age <60y. This is a prospective, single-armed mono-center based investigator-initiated trial. About 30 patients who meet the enrollment criteria with be treated with CHA as induction chemotherapy. The complete response rate, survival rate, recurrence rate, and treatment-related mortality with be observed.

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Catégorie de traitement

Chimiothérapie, Autres médicaments

Mutations requises

Aucun

Essai commencé

26 octobre 2022

Dernière mise à jour par le sponsor

7 mai 2025

Achèvement estimé

31 août 2025

Contact de l'étude

Nom:Zhen Cai, MD, Ph.D

E-mail:caiz@zju.edu.cn

Téléphone:+86 138 5719 0311

Éligibilité

Critères d'inclusion

1. The age is 18 to 59 years old, gender is not limited, race is not limited.

2. Diagnosed as acute myeloid leukemia (AML) according to the diagnostic criteria of the World Health Organization (WHO) in 2016.

3. No previous anti-acute leukemia therapy (including demethylation drugs for leukemia or myelodysplastic syndrome (MDS), except hydroxyurea and leukocytosis).

4. Physical status <= 2 according to eastern tumor cooperation group (ECOG).

5. Within 21 days before random grouping and at baseline, biochemical indicators must be within the following limits: Glutamic pyruvic transaminase (ALT) and glutamic oxaloacetic transaminase (AST) <= 3 × normal upper limit (ULN); total bilirubin <= 3 × ULN; serum creatinine <= 2 × ULN or serum creatinine clearance rate (CrCl)>= 40mL/min.

6. The left ventricular ejection fraction| (LVEF) measured by echocardiography was in the normal range (LVEF > 50%).

7. Each patient (or his or her legal representative) must sign an informed consent form (ICF), indicating that he / she understands the purpose and procedures of the study and is willing to participate in the study.

Critères d'exclusion

1. Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future.

2. Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia.

3. Patients with severe liver and kidney function, cardiopulmonary insufficiency.

4. Uncontrolled or severe infection.

5. Mental illness that may prevent subjects from completing treatment or informed consent.

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Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire30

Bras et interventions

Bras

Interventions

Type : Experimental

Description : Intervention: CHA

Interventions :

cladribine + homoharringtonine + cytarabine

Mesures des résultats

Mesures des résultats primaires

Complete response (CR) rateAt the end of Cycle 1 (each cycle is 28 days)

no signs of leukemia after treatment, fewer than 5% blasts in the BM, absolute neutrophil count (ANC) ≥ 1.0×109/L and platelet count ≥ 100×109/L and absence of the extramedullary tumor

Overall Survival Rate2 years since enrollment

the ratio of cases alive to total enrolled cases within 2 years since enrollment

Disease-free Survival Rate2 years since enrollment

the ratio of cases with leukemia complete remission to the total enrolled cases within 2 years since enrollment

Mesures des résultats secondaires

Recurrence Rate2 years since enrollment

the ratio of cases with leukemia relapse to the total enrolled cases within 2 years since enrollment

Treatment-related mortality30 days since treatment

the ratio of cases who died within 30 days since treatment to total enrolled cases

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Sites d'essai

Cette étude compte 1 site d'essai

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, CN

Nom:Jie Sun, MD, Ph.D

Recrutement en cours

Hangzhou, Zhejiang, 310003 CN

The First Affiliated Hospital, Zhejiang University School of Medicine

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