Hematologic MalignancyPhase 2NCT05084027
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
A Phase 2 study testing venetoclax combining with fludarabine and melphalan in people with Hematologic Malignancy and Older Patients, run by First Affiliated Hospital of Zhejiang University at 8 sites in China.
Trial summary
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hematologic Malignancy, Older Patients, Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- venetoclax combining with fludarabine and melphalan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesChina
- Study dates
- 7 Oct 2021to 30 Sep 2024
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 50 years
- Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.
- Patients who achieved complete remission before transplantation.
- Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
- ECOG body status score 0-2.
- 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%).
- Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
Who cannot join
- Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence.
- Patients who were previously known to be resistant to venetoclax.
- 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.
- Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
- 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.
- In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
- Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
- Other reasons why the researchers could not be selected.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yi Luo, M.D., +86057187233801, luoyijr@163.com
- Recruiting
First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang
Baodong Ye, MD, +8657187236706, 13588453501@qq.com
- Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Yang Xu, MD, +8657187236706, zjuyujian@126.com
- Recruiting
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Hangzhou
Haowen Xiao, MD, +86057187236706, xiaohaowen@zju.edu.cn
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Jianping Lan, MD, +8657187236706, lanjp@163.com
- Recruiting
Ningbo Hospital of Zhejiang University
Ningbo
Guifang Ouyang, MD, +86057187233801, luoyijr@163.com
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo
Ying Lu, MD, +86057187236706, luying741107@qq.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Yi Chen, MD, +8657187236706, chenyi19527@163.com
About this study
Official title: Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies
Read the detailed 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.
- Conditions
- Hematologic Malignancy, Older Patients, Allogeneic Hematopoietic Stem Cell Transplantation
- Being tested
- venetoclax combining with fludarabine and melphalan
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venetoclax combining with fludarabine and melphalanCombination product
Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment Receives: Combination Product: venetoclax combining with fludarabine and melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
2-year DFS
Measured: 2 year
Secondary outcomes (4)
incidence of toxic reaction
2-year incidence of toxic reaction
Measured: 2 year
overall survival
2-year OS
Measured: 2 year
cumulative incidence of relapse
2-year incidence of relapse
Measured: 2 year
incidence of acute and or chronic graft verus host disease
2-year incidence of cGVHD
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start7 Oct 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, The Affiliated People's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
- Investigators
- Yi Luo, M.D., Principal investigator, First Affilaated Hospital of Medical School of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084027
- Sponsor's protocol ID
- ZJU-HSCT-RIC
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai X, Zhu P, Yang L, Liu L, Wu Y, Shi J, Yu J, Zhao Y, Ouyang G, Chen Y, Ye Y, Zhang P, Sun L, Zheng W, Sun J, Huang H, Luo Y. Integration of venetoclax into a fludarabine and melphalan conditioning regimen in patients aged 50 years and older with acute myeloid leukemia and myelodysplastic syndrome: Results from a phase 2 clinical trial. Cancer. 2026 Jun 1;132(11):e70467. doi: 10.1002/cncr.70467.
PubMed 42159161
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05084027
- Acronym / sponsor ID
- ZJU-HSCT-RIC
- Conditions
- Hematologic Malignancy, Older Patients, Allogeneic Hematopoietic Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, The Affiliated People's Hospital of Ningbo University, First Affiliated Hospital of Wenzhou Medical University, Ningbo Hospital of Zhejiang University, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Combination Product: venetoclax combining with fludarabine and melphalanolder patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age older than 50 years
- Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.
- Patients who achieved complete remission before transplantation.
- Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
- ECOG body status score 0-2.
Key exclusion criteria (8 listed)
- Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence.
- Patients who were previously known to be resistant to venetoclax.
- 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.
- Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venetoclax combining with fludarabine and melphalanVenetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2 | Combination product | treatment group |
Primary outcome
disease free survival
Time frame: 2 year
2-year DFS
4 secondary outcomes
incidence of toxic reaction
Time frame: 2 year
overall survival
Time frame: 2 year
cumulative incidence of relapse
Time frame: 2 year
incidence of acute and or chronic graft verus host disease
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 42159161Lai X, Zhu P, Yang L, Liu L, Wu Y, Shi J, Yu J, Zhao Y, Ouyang G, Chen Y, Ye Y, Zhang P, Sun L, Zheng W, Sun J, Huang H, Luo Y. Integration of venetoclax into a fludarabine and melphalan conditioning regimen in patients aged 50 years and older with acute myeloid leukemia and myelodysplastic syndrome: Results from a phase 2 clinical trial. Cancer. 2026 Jun 1;132(11):e70467. doi: 10.1002/cncr.70467.
- Individual participant dataSharing planned: No
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Luo, M.D. principal investigator
First Affilaated Hospital of Medical School of Zhejiang University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing venetoclax combining with fludarabine and melphalan in people with Hematologic Malignancy and Older Patients, run by First Affiliated Hospital of Zhejiang University at 8 sites 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 7 inclusion and 8 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Yi Luo, M.D. (+86057187233801, luoyijr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: 2 year). 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 NCT05084027, which also lists 1 linked publication.
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 27 Oct 2021.