Acute Myeloid LeukemiaPhase 2NCT06133556
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
A Phase 2 study testing MCBC regimen and Bu/Cy regimen in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- MCBC regimen and Bu/Cy regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2023to 20 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Refractory / relapsed AML.
- Patients with a HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor, plan to receive HSCT.
- Age ≤ 60 years old, men and women are not limited.
- The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
- Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or his or her immediate family members who are 18 years of age or older ; informed consent was signed by the legal guardian for children and adolescent patients under 18 years old. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Who cannot join
- Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).
- MPAL.
- It is known that the serological reaction of HIV or active hepatitis C virus is positive.
- The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.
- Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.
- Previously received hematopoietic stem cell transplantation.
Show all 13Show fewer
- Active heart disease, defined as one or more of the following :
- ) Uncontrolled or symptomatic angina history.
- ) Myocardial infarction less than 6 months away from the study.
- ) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms.
- ) Uncontrolled or symptomatic congestive heart failure ( > NYHA class 2 ).
- ) The ejection fraction is lower than the lower limit of the normal range.
- Researchers evaluated that is not suitable for the group.
About this study
This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- MCBC regimen, Bu/Cy regimen
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCBC regimenDrug
Also called experiment group
using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d； Cy 30mg/kg -2~-1 d
Bu/Cy regimenDrug
Also called classic group
control group, the standard conditioning regimen Busulfan/Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| control arm | Active comparator | Busulfan/Cyclophosphamide, "standard" conditioning regimen as a control group. including Bu3.2mg/kg -5~-3d; Cy 80mg/kg，-2~-1d。 or alternative Bu/Cy regimen, Bu3.2mg/kg -9~-7d；Flu 30mg/m2 -6~-4d；Ara-C 2g/m2 -6~-4d；Cy 80mg/kg -3~-2d。 Receives: Drug: Bu/Cy regimen |
| MCBC group | Experimental | using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d； Cy 30mg/kg -2~-1 d Receives: Drug: MCBC regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
The AML relapse free survival post-HSCT
Measured: 3 year post-HSCT
Secondary outcomes (5)
Overall Survival
The overall survival post-HSCT
Measured: 3 year post-HSCT
cumulative incidence relapse rate
cumulative incidence relapse rate post-HSCT
Measured: 3 year post-HSCT
Non-relapse mortality
Non-relapse mortality post-HSCT
Measured: 3 year post-HSCT
toxicity of conditioning regimen
Adverse events as assessed by CTCAE to evaluate conditioning related toxicity
Measured: 24w post-HSCT
Immune reconstitution post-HSCT
Using lymphocyte subset panel to assess immune recovery post-HSCT
Measured: 24w post-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start24 Nov 2023 (estimated)
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133556
- Sponsor's protocol ID
- IIT2023023-EC-2
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
- ClinicalTrials.gov ID
- NCT06133556
- Acronym / sponsor ID
- IIT2023023-EC-2
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 24 Nov 2023 (estimated)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 15 Nov 2023 (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.
This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | Active comparator | Drug: Bu/Cy regimenBusulfan/Cyclophosphamide, "standard" conditioning regimen as a control group. including Bu3.2mg/kg -5~-3d; Cy 80mg/kg，-2~-1d。 or alternative Bu/Cy regimen, Bu3.2mg/kg -9~-7d；Flu 30mg/m2 -6~-4d；Ara-C 2g/m2 -6~-4d；Cy 80mg/kg -3~-2d。 |
| MCBC group | Experimental | Drug: MCBC regimenusing MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d； Cy 30mg/kg -2~-1 d |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Refractory / relapsed AML.
- Patients with a HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor, plan to receive HSCT.
- Age ≤ 60 years old, men and women are not limited.
- The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
- Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or his or her immediate family members who are 18 years of age or older ; informed consent was signed by the legal guardian for children and adolescent patients under 18 years old. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Key exclusion criteria (13 listed)
- Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).
- MPAL.
- It is known that the serological reaction of HIV or active hepatitis C virus is positive.
- The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.
- Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.
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 |
|---|---|---|
| MCBC regimenAlso: experiment groupusing MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d； Cy 30mg/kg -2~-1 d | Drug | MCBC group |
| Bu/Cy regimenAlso: classic groupcontrol group, the standard conditioning regimen Busulfan/Cyclophosphamide | Drug | control arm |
Primary outcome
Relapse Free Survival
Time frame: 3 year post-HSCT
The AML relapse free survival post-HSCT
5 secondary outcomes
Overall Survival
Time frame: 3 year post-HSCT
cumulative incidence relapse rate
Time frame: 3 year post-HSCT
Non-relapse mortality
Time frame: 3 year post-HSCT
toxicity of conditioning regimen
Time frame: 24w post-HSCT
Immune reconstitution post-HSCT
Time frame: 24w post-HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCBC regimen and Bu/Cy regimen in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Free Survival (time frame: 3 year post-HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2023.