High-dose irradiation followed by immunotherapy for high-risk leukemia patients

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 study evaluates the effectiveness of a treatment approach that combines high-dose total marrow and lymphoid irradiation with adoptive immunotherapy using donor Treg and conventional T cells for patients with high-risk acute leukemia. It focuses on patients who are undergoing allogeneic hematopoietic stem cell transplantation and have specific genetic risks or active disease. The study aims to enhance the potency of the transplantation process to improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* AML patients

  * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
  * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
  * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
  * Age ≥ 18 and ≤ 65 years
  * ECOG ≤ 2
  * HCT-CI ≤ 4 (51,52)
  * Absence of relevant psychiatric diseases
  * Signature of the informed consent

ALL patients

* Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
* Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
* Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
* Age ≥ 18 and ≤ 65 years
* ECOG ≤ 2
* HCT-CI ≤ 4
* Absence of relevant psychiatric diseases
* Signature of the informed consent

Exclusion Criteria:

* AML patients

  * AML in CR MRD-
  * AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
  * Age \< 18 years or \> 65 years
  * ECOG \> 2
  * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  * Pregnancy
  * No signature of the informed consent
* ALL patients

  * ALL with \> 5% peripheral blasts or bone marrow infiltration ≥30%
  * Philadelphia positive ALL
  * Age \< 18 years or \> 65 years
  * ECOG \> 2
  * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
  * Pregnancy
  * No signature of the informed consent

Where it's running

• Università degli Studi di Perugia
  Perugia, Pg, Italy Recruiting

Study contacts

• Study coordinator: Antonio Pierini
• Email: antonio.pierini@unipg.it
• Phone: +393355477611

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAYA cancer patients in LMICs: a forward-looking observation of care and outcomes

  This study follows children, teens, and young adults with cancer in low- and middle-income countries to see how routine care affects treatment, access, and outcomes over time.

  Recruiting Resonance, Inc. · Yerevan and 5 other locations · NCT07632014

• First-in-human testing of 4A10 for relapsed or hard-to-treat ALL and lymphoblastic lymphoma

  This early-stage trial tests a new antibody therapy called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia or lymphoblastic lymphoma to see if it is safe and how the body handles it.

  Recruiting at 5 sites Phase 1 Allterum Therapeutics, Inc · Aurora, Colorado and 6 other locations · NCT07586618

• Plasma cell-free DNA in children with ALL to help monitor disease

  This study tests whether measuring tumor DNA in blood can help monitor acute lymphoblastic leukemia in kids without needing frequent bone-marrow tests.

  Recruiting at 2 sites Assistance Publique - Hôpitaux de Paris · Paris and 1 other locations · NCT07483476

• Laughter and fun yoga to ease chemotherapy pain in children

  This tests whether a home-based program of laughter and kid-friendly yoga can lower pain in children aged 2–10 who are receiving chemotherapy for acute lymphoblastic leukemia.

  Recruiting Beirut Arab University · Sidon · NCT07327138

• Tracking and predicting chemotherapy-related nerve damage in children with acute lymphoblastic leukemia

  Researchers will track how vincristine-related nerve damage develops over time in children (ages 8–17) with acute lymphoblastic leukemia and try to identify factors that predict different symptom patterns.

  Recruiting at 3 sites The Hong Kong Polytechnic University · Zhengzhou, Henan and 2 other locations · NCT07326930

• Optimizing and Unifying Management of HSCT in Pediatric ALL

  This trial tests a harmonized HSCT approach for children and young people with ALL, aiming to reduce transplant-related risks and improve long-term outcomes.

  Recruiting at 2 sites Phase 2/3 Bambino Gesù Hospital and Research Institute · Vienna and 8 other locations · NCT07297914

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.