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NCT05009719CompletedPhase 1/2

Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy

Study of the Efficacy and Safety of Risk-adapted Donor Lymphocyte Infusions for the Prophylaxis and Prevention of Relapses After Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescent With Hematologic Malignancy

Source: ClinicalTrials.gov · Last updated 25 Jun 2024

Brief summary (registry, in English)

Allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. However, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after HSCT. Donor lymphocytes infusion (DLI) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". This study evaluates the safety and efficacy of risk-adapted srtategy of DLI for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
50 (actual)
First submitted
16 Aug 2021
Start date
1 Apr 2021
Primary completion date
1 Apr 2023
Lead sponsor
St. Petersburg State Pavlov Medical University
NCT number
NCT05009719

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 50
  • From 1 Apr 2021 to the primary completion date, 1 Apr 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled bacterial or fungal infection at the time of enrollment
  • Somatic or psychiatric disorder making the patient unable to sign an informed consent

Lab values

  • Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
  • Ejection fraction less than 50%

Other

  • Requirement for vasopressor support at the time of enrollment
  • Acute GVHD grade 3-4 in patient medical history
  • Severe chronic GVHD in patient medical history

Who the study is looking for

  • Age 4 months - 18 years old
  • Diagnosis: acute lymphoblastic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, chronic myeloid leukemia
  • Signed by legal representatives informed consent
  • High risk disease ( for ALL - initial hyperleukocytosis\> 50x109 / L, T-cell ALL, hypodiploid karyotype, complex karyotype, MLL gene rearrangement, SIL-TAL deletion, primary resistent of the disease, early/very earle relapse, infant ALL; for AML patients - rearrangement of the MLL gene (except for t (1; 11) and t (9; 11) with M5 morphology), inv (3), t (3; 3), complex karyotype anomalies, t (8; 21 ) with trisomy 4, t (16; 21), monosomy 7, monosomy 5, M7 without t (1; 22), FLT3+, M6, t (7; 12), AML with multilineage dysplasia, p53 gene mutations, NUP98 translocations, primary resistent of the disease, early/very earle relapse infant AML, secondary AML; all juvenile myelomonocytic leukemia and myelodysplastic syndrome; allo-HSCT at 3 or more remission; persistence MRD before alloHSCT; allo-HSCT out of remission; persistence MRD after alloHSCT; cytogenetic relapse after alloHSCT )
  • Donor chimerism=\>95%
  • No poor graft function (haemoglobin concentration \< 100 g/L; neutrophils \< 1.0 × 10E + 9/L; and platelets \< 30 × 10E + 9/L on day ≥ 30 post transplant with complete donor chimerism and no graft-versus-host disease or relapse )
  • ECOG 0-2 status
  • Karnofsky/Lansky status \>30%

Age in the registry: 4 months to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
RM Gorbacheva Research Institute
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Saint PetersburgRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.