Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05084027
Other study ID # ZJU-HSCT-RIC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 7, 2021
Est. completion date September 30, 2024

Study information

Verified date October 2021
Source First Affiliated Hospital of Zhejiang University
Contact Yi Luo, M.D.
Phone +86057187233801
Email luoyijr@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies


Description:

It was a phase Ⅱ clinical trial of new designed reduced-intensity conditioning regimen for older patients accepting allogeneic hematopoietic stem cell transplantation treatment. The regimen consisted of venetoclax combining with fludarabine and melphalan.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 30, 2024
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age older than 50 years 2. Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria. 3. Patients who achieved complete remission before transplantation. 4. Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment. 5. ECOG body status score 0-2. 6. Good organ function level: ANC (neutrophil absolute value >=1.0x10^9/L; PLT >=30x10^9/L; HB >=80g/L; Tibil <=1.5 ULN; ALT / AST <=2.5 ULN; bun / Cr <=1.5 ULN; LVEF >=50%). 7. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing. Exclusion Criteria: 1. Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence. 2. Patients who were previously known to be resistant to venetoclax. 3. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme. 4. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment. 5. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme. 6. In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment. 7. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study. 8. Other reasons why the researchers could not be selected.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
venetoclax combining with fludarabine and melphalan
Venetoclax 400mg/day,oral,day-8~day-2; Fludarabine, 30mg/m2/day,intravenous,d-7~d-3;Melphalan, 140mg/ m2/d,intravenous,day-2

Locations

Country Name City State
China First Affiliated Hospital of Zhejiang Chinese Medicine University Hangzhou Zhejiang
China Second Affiliated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang
China Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University Hangzhou
China The first Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
China Zhejiang Provincial People's Hospital Hangzhou
China Ningbo Hospital of Zhejiang University Ningbo
China The Affiliated People's Hospital of Ningbo University Ningbo
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou

Sponsors (8)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, The affiliated people's hospital of Ningbo University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease free survival 2-year DFS 2 year
Secondary incidence of toxic reaction 2-year incidence of toxic reaction 2 year
Secondary overall survival 2-year OS 2 year
Secondary cumulative incidence of relapse 2-year incidence of relapse 2 year
Secondary incidence of acute and or chronic graft verus host disease 2-year incidence of cGVHD 2 year
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT04889937 - Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Not yet recruiting NCT05820126 - Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial Phase 2
Active, not recruiting NCT04509765 - A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT N/A
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Withdrawn NCT03986086 - MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Phase 1/Phase 2
Completed NCT02512666 - Non Invasive Optical Imaging of WBC Count N/A
Withdrawn NCT02207764 - Reiki as a Complementary Therapy: A Pilot Study N/A
Not yet recruiting NCT02193399 - Physiotherapy in Hematopoietic Stem Cell Transplantation N/A
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Terminated NCT01215981 - Influenza Vaccine Post Allogeneic Transplant N/A
Completed NCT00333190 - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation N/A
Withdrawn NCT04392128 - Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE) Phase 2
Recruiting NCT06102213 - Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation Phase 2
Active, not recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Completed NCT03654404 - A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients N/A
Recruiting NCT05384288 - Response to Influenza Vaccination in Pediatric Oncology Patients
Active, not recruiting NCT05180838 - Remote Temperature Data for Early Detection of Febrile Neutropenia