Relapsed Adult ALLPhase 2NCT06141304

Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT

A Phase 2 study testing Plerixafor in people with Relapsed Adult ALL and Relapsed Adult AML, run by The First Hospital of Jilin University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 14 to 60 years
Conditions the study is for: Relapsed Adult ALL, Relapsed Adult AML
What is being tested?: Plerixafor
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 1 Sep 2023to Jul 2025
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 14 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

The age of the patients is ≥ 14 and ≤ 60 years old;
Those with relapsed acute leukemia after allo-HSCT with bone marrow blasts less than 50%;
The expected survival exceeds 3 months;
At least 100 days post transplantation, and the immunosuppressants were discontinued;
Those with no significant abnormalities of the main organ function: creatinine ≤ 176.8 μ Mol/L, bilirubin ≤ 51.3 μ Mol/L, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the normal upper limit;
Sign an informed consent form.

Who cannot join

Those with patient-specific human leukocyte antigen (HLA) loss at relapse;
Those with active graft-versus-host disease;
Those with severe infection;
Those with organ function failure;
Those with an Eastern Cooperative Oncology Group (ECOG) score more than 2 points;
Those who are allergic to experimental drugs;

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Those who use other anti-leukemia therapies, such as radiotherapy, cellular immunotherapy, or Chinese medical herbs;
Those participate in other clinical trials simultaneously;
Those having mental illness or other illnesses that cannot fully comply with treatment or follow-up requirements;
Those with extramedullary leukemia;
Those with other conditions that researchers evaluate who are not proper to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

First Hospital of Jilin University
Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Single Arm Study of Using Plerixafor Plus Donor Lymphocyte Infusion in the Treatment of Patients With Relapsed Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation

Acute leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), is the subtype of leukemia with the highest mortality, and leukemia relapse caused by the protective bone marrow microenvironment is the main cause of treatment failure. The chemokine receptor CXCR4 plays a crucial role in the homing and settling of leukemia cells into the bone marrow. Preclinical study of the investigators demonstrates that CXCR4 blockade can mobilize leukemia cells from their protective bone marrow microenvironment to periphery, thereby significantly enhancing the killing effect of allogeneic lymphocytes against leukemia cells. This study aims to preliminarily evaluate the efficacy and safety of donor lymphocyte infusion (DLI) plus CXCR4 antagonist plerixafor in the treatment of relapsed acute leukemia patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) through a prospective single arm study. The results may preliminarily confirm the effectiveness and safety of DLI combined with plerixafor in the treatment of recurrent acute leukemia patients after allo-HSCT, providing a reference basis for further research.

Read the detailed description

Patients with relapsed acute leukemia post allo-HSCT will be screened for the eligibility of this clinical trial. The participants will receive chemotherapy to reduce leukemia burden followed by DLI three days later. Ten days post DLI, plerixafor will be administrated to the participants (subcutaneous injection, twice per day) for a consecutive five days. The second round of DLI plus plerixafor will be given if the participants achieving partial remission or complete remission with positive minimal measurable disease. Short-term responses and long-term outcomes will be evaluated and safety of this therapeutic regimen will be assessed.

Conditions: Relapsed Adult ALL, Relapsed Adult AML
Being tested: Plerixafor
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlerixaforDrug
Also called AMD3100
Plerixafor was injected subcutaneously to participants twice per day for five consecutive days ten days post DLI.

Study groups in NCT06141304
Study group	Role	What they receive
Plerixafor plus DLI	Experimental	DLI will be given to the participants three days after chemotherapy, and plerixafor will be administrated ten days post DLI. Receives: Drug: Plerixafor

What is being measured

The primary outcome is the main question the study is designed to answer.

Remission rates of the enrolled participants
The remission rates of the participants include complete remission rate, partial remission rate, and overall response rate.
Measured: Three months

Secondary outcomes (5)

Disease-free survival (DFS) of the enrolled participants
DFS is defined from achievement of complete remission to disease relapse.
Measured: Twelve months
Overall survival of the enrolled participants
DFS is defined from enrollment to death, last contact, or end of this clinical trial.
Measured: Twelve months
Number of participants with acute and chronic graft-versus-host disease (GVHD)
Any grade of acute and chronic GVHD of the participants will be recorded. The acute GVHD will be assessed by MAGIC guidelines and chronic GVHD will be assessed by National Comprehensive Cancer Network (NCCN) guidelines.
Measured: Twelve months
Number of participants with non-relapse mortality
Non-relapse mortality (NRM) is defined as any cause of death without leukemia relapse.
Measured: Twelve months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Treatment-related adverse events will be assessed by CTCAE v5.0, including hematological and non-hematological adverse events. However, the occurrence of GVHD is not included.
Measured: One month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2023Jul 2025

First posted21 Nov 2023
Study start1 Sep 2023
Primary completionJan 2025 (estimated)
Study completionJul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed Adult ALLStudies of the same condition, open and under way.
More trials run by The First Hospital of Jilin 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
Model description: Plerixafor plus donor lymphocyte infusion for patients with relapsed acute leukemia
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06141304
Sponsor's protocol ID: MLEU
Status last verified: Nov 2023
First submitted: 15 Nov 2023
Last updated: 21 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
RecruitingObservational study
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
Lymphoma, Leukemia
RecruitingPhase 1
Evaluation of LB-208 (HTR1B Antagonist) in Adult Patients With Relapsed or Refractory Solid Tumours and Lymphoma
Solid Tumor Malignancies, Lymphoma
RecruitingPhase 2
A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

All Relapsed Adult ALL trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm Study of Using Plerixafor Plus Donor Lymphocyte Infusion in the Treatment of Patients With Relapsed Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06141304
Acronym / sponsor ID: MLEU
Conditions: Relapsed Adult ALL, Relapsed Adult AML
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 28 participants (estimated)
Lead sponsor: The First Hospital of Jilin UniversityUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: Jan 2025 (estimated)
Study completion: Jul 2025 (estimated)
First posted: 21 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Plerixafor plus donor lymphocyte infusion for patients with relapsed acute leukemia

Arm	Type	Receives
Plerixafor plus DLI	Experimental	Drug: PlerixaforDLI will be given to the participants three days after chemotherapy, and plerixafor will be administrated ten days post DLI.

Who may qualify

Ages: 14 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

The age of the patients is ≥ 14 and ≤ 60 years old;
Those with relapsed acute leukemia after allo-HSCT with bone marrow blasts less than 50%;
The expected survival exceeds 3 months;
At least 100 days post transplantation, and the immunosuppressants were discontinued;
Those with no significant abnormalities of the main organ function: creatinine ≤ 176.8 μ Mol/L, bilirubin ≤ 51.3 μ Mol/L, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the normal upper limit;

Key exclusion criteria (11 listed)

Those with patient-specific human leukocyte antigen (HLA) loss at relapse;
Those with active graft-versus-host disease;
Those with severe infection;
Those with organ function failure;
Those with an Eastern Cooperative Oncology Group (ECOG) score more than 2 points;

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
PlerixaforAlso: AMD3100Plerixafor was injected subcutaneously to participants twice per day for five consecutive days ten days post DLI.	Drug	Plerixafor plus DLI

Primary outcome

Remission rates of the enrolled participants
Time frame: Three months
The remission rates of the participants include complete remission rate, partial remission rate, and overall response rate.

5 secondary outcomes

Disease-free survival (DFS) of the enrolled participants
Time frame: Twelve months
Overall survival of the enrolled participants
Time frame: Twelve months
Number of participants with acute and chronic graft-versus-host disease (GVHD)
Time frame: Twelve months
Number of participants with non-relapse mortality
Time frame: Twelve months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: One month after treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.

Related trials for Relapsed Adult ALL

RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
RecruitingObservational study
Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy
Lymphoma, Leukemia
RecruitingPhase 1
Evaluation of LB-208 (HTR1B Antagonist) in Adult Patients With Relapsed or Refractory Solid Tumours and Lymphoma
Solid Tumor Malignancies, Lymphoma
RecruitingPhase 2
A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

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.

Long Su, PhD study director

The First Hospital of Jilin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plerixafor in people with Relapsed Adult ALL and Relapsed Adult AML, run by The First Hospital of Jilin University at 1 site 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 6 inclusion and 11 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Remission rates of the enrolled participants (time frame: Three months). 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 NCT06141304.

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 21 Nov 2023.