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Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06105658 est conçu pour étudier le treatment de Acute Myelocytic Leukemia. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 1 octobre 2023 et vise à recruter 20 participants. Dirigé par Anhui Provincial Hospital, l'essai devrait être terminé d'ici le 1 février 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 30 octobre 2023.
Résumé succinct
This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.
Titre officiel

A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia

Conditions
Acute Myelocytic Leukemia
Autres identifiants de l'essai
  • UCB-MST&AML
Numéro NCT
NCT06105658
Date de début (réel)
2023-10
Dernière mise à jour publiée
2023-10-30
Date de fin (estimée)
2026-02-01
Inscription (estimée)
20
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalChemotherapy+unrelated umbilical cord blood microtransplantation
Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".
Unrelated Umbilical Cord Blood
The requirements of unrelated umbilical cord blood: recipient-donor HLA match is 0-3/10, same blood type.
Venetoclax
Patients will be treated with Venetoclax (100 mg on day 1, 200 mg on day 2 and 400 mg on days 3 to 21)
Decetabine
Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7)
Azacitidine
Patients will be treated with Decetabine (20mg/m\^2/d on days 1 to 5) or Azacitidine (75mg/m\^2/d on days 1 to 7)
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Complete response (CR) rate
CR rate is defined as the percentage of patients who met the following conditions: Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count \> 1.0×10\^9/L, platelet count \> 100×10\^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion.
28±7days
Hematopoietic recovery time
The time of absolute neutrophil count\>0.5×10\^9/L and platelet count \>30×10\^9/L for 3 consecutive days.
28±7days
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Time to Progression（TTP）
Time from enrollment to objective progression of disease
1 year
Disease Free Survival（DFS）
From CR to recurrence or death or to the date of last follow-up
1 year
Overall Survival（OS）
From the beginning of treatment to death or to the date of last follow-up
1 year
Early mortality rate
Death within the first 3 months of induction therapy
3 months
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
14 Years
Sexes éligibles
Tous

  1. Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:

    Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).

    Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;

  2. Gender and race are not limited;

  3. Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

  4. Expected survival time ≥ 3 months;

  5. The examination results meet the following requirements:

    ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (>50%);

  6. The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;

  7. Patients who voluntarily participate in this clinical study and have signed an informed consent.

  1. Patients who have suffered from malignant tumors;
  2. Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
  3. Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
  4. Suffering from life-threatening diseases other than AML;
  5. Allergic to the drugs in the research;
  6. Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;
  7. Patients with test positive for HIV, HCV or HBV;
  8. Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
  9. Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
  10. Patients with mental illnesses or cognitive impairments;
  11. Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
  12. There are other conditions that the investigators consider inappropriate for inclusion.
Anhui Provincial Hospital logoAnhui Provincial Hospital
Partie responsable de l'essai
Xiaoyu Zhu, Investigateur principal, Principal Investigator, Anhui Provincial Hospital
Contact central de l'essai
Contact: Xiaoyu Zhu, MD, 15255456091, [email protected]
1 Centres de l'essai dans 1 pays

Anhui

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, 230001, China
Xiaoyu Zhu, MD, Contact, 15255456091, [email protected]
En recrutement