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Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia

ConditionsRelapsed LeukemiaRefractory Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age15+
SponsorBeijing 302 Hospital

About this trial

This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >=15 years, male or female, non-limited by race or ethnicity.

Confirmed diagnosis of R/R leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.

Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.

Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.

Disqualifiers

Uncontrolled infection or hemorrhage.

Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.

Uncontrolled autoimmune disease or requiring immunosuppression treatment.

History of severe blood infusion reaction.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chemotherapy

    Procedure/Surgery

    Available chemotherapy regimens include but not limited to FLAG (fludarabine, cytarabine, G-CSF), DAV (daunorubicin, cytarabine, venetoclax), IAV (idarubicin, cytarabine, venetoclax), VDCP (vincristine, daunorubicin, cyclophosphamide, prednisone), hyper-CVAD A (cyclophosphamide, vincristine, doxorubicin, dexamethasone), FC (fludarabine and cyclophosphamide), et al.

  • HLA-mismatched GPBMC infusion

    Biological/Vaccine

    HLA-mismatched GPBMCs are infused following chemotherapy.

  • Allogeneic Stem Cell Transplantation

    Procedure/Surgery

    Patients receive conditioning including but not limited to fludarabine, cyclophosphamide, antithymocyte globulin (ATG), and total body irradiation (TBI). HLA-matched sibling/haploidentical/unrelated GPBMCs are infused at day 0. Post-transplant cyclophosphamide, tacrolimus/cyclosporin, and mycophenolate mofetil are administered as graft-versus-host disease prophylaxis.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Cohort 1Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Graft-Versus-Host Disease (GVHD)

Including acute GVHD (aGVHD) and chronic GVHD (cGVHD), assessed per international universal criteria (e.g., Glucksberg classification).

Time frame
Measured up to 2 years after the last participant is enrolled
2

Infections

Covering bacterial, viral, fungal infections (e.g., pneumonia, sepsis, cytomegalovirus infection), confirmed based on clinical symptoms, laboratory tests, and etiological evidence.

Time frame
Measured up to 2 years after the last participant is enrolled
3

Hematological Toxicity

Including neutropenia, thrombocytopenia, anemia, etc., graded according to the Common Terminology Criteria for Adverse Events (CTCAE) standards.

Time frame
Measured up to 2 years after the last participant is enrolled

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from the completion of allo-HSCT to disease progression, relapse, or death from any cause.

Time frame
Measured up to 4 years after the last participant is enrolled
2

Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS)

Time from the completion of allo-HSCT to the first occurrence of any of the following events: grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, disease relapse, or death.

Time frame
Measured up to 4 years after the last participant is enrolled
3

Overall Survival (OS)

Time from the completion of allo-HSCT to death from any cause.

Time frame
Measured up to 4 years after the last participant is enrolled
4

Treatment-Related Mortality (TRM)

TRM is defined as the death related to treatment instead of disease progression.

Time frame
Measured up to 2 years after the last participant is enrolled

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov
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