Chemotherapy plus HLA-mismatched G-CSF mobilized peripheral blood cells as a bridge to allogeneic stem cell transplant for relapsed or refractory leukemia
Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia
This trial will test whether adding an HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell infusion to chemotherapy can safely help people with relapsed or refractory leukemia reach an allogeneic stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07297173 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label approach gives eligible patients chemotherapy combined with an infusion of HLA-mismatched G-CSF mobilized peripheral blood mononuclear cells (GPBMCs) to reduce leukemia burden, followed by allogeneic hematopoietic stem cell transplantation per protocol. The GPBMCs used for the first infusion may come from a sibling or unrelated donor who is HLA-mismatched, while the allo-HSCT donor may be the same or a different qualified donor (matched sibling, 9–10/10 loci matched unrelated, or haploidentical). The primary endpoint is the incidence of treatment-related adverse events within 100 days after allo-HSCT, including graft-versus-host disease, infection, organ dysfunction, and hematologic toxicity. Secondary endpoints include overall survival at 1 and 2 years, progression-free survival, and graft-versus-host disease-free, relapse-free survival (GRFS).
Who should consider this trial
Good fit: Adolescents and adults aged 15 years or older with relapsed or refractory leukemia who have an available HLA-mismatched donor for GPBMC donation and a qualified allo-HSCT donor are the intended candidates.
Not a fit: Patients without suitable donors, those with significant liver, renal, or cardiac impairment beyond protocol limits, or those who are not candidates for allo-HSCT are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could lower leukemia burden enough to allow more patients to reach and benefit from potentially curative allogeneic stem cell transplantation.
How similar studies have performed: Related approaches such as donor cell infusions and haploidentical transplants have shown promise in some settings, but using HLA-mismatched GPBMC infusion specifically as a bridge to allo-HSCT is relatively novel and early-stage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * LVEF measured by echocardiogram is within the normal range (LVEF \> 50%). * The subject must have one HLA mismatched donor who is \>= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is \>= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10/10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research. * Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form. Exclusion Criteria: * 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. * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. * Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements. * Major surgery within 4 weeks prior to enrollment. * Life-threatening illness other than leukemia or uncontrolled intercurrent illness.
Where this trial is running
Beijing
- Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Bo Cai, MD — Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
- Study coordinator: Bo Cai, MD
- Email: caibo2008@163.com
- Phone: +861066947168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.