Chemotherapy plus HLA-mismatched G-CSF mobilized peripheral blood cells as a bridge to allogeneic stem cell transplant for relapsed or refractory leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.