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Hematologic MalignancyPhase 1/2NCT05009719

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

A Phase 1/2 study testing Prophylactic Donor lymphocytes infusions and Preventive Donor lymphocytes infusions in people with Hematologic Malignancy, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 months to 18 years
Conditions the study is for
Hematologic Malignancy
What is being tested?
Prophylactic Donor lymphocytes infusions and Preventive Donor lymphocytes infusions
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRussia
Study dates
1 Apr 2021to 1 Apr 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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%

Who cannot join

  • Uncontrolled bacterial or fungal infection at the time of enrollment
  • 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%
  • Requirement for vasopressor support at the time of enrollment
  • Somatic or psychiatric disorder making the patient unable to sign an informed consent
  • Acute GVHD grade 3-4 in patient medical history
  • Severe chronic GVHD in patient medical history

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • RM Gorbacheva Research Institute

    Saint Petersburg, 197022

Other trials in Russia

About this study

Official title: 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

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.

Being tested
Prophylactic Donor lymphocytes infusions, Preventive Donor lymphocytes infusions
Keywords
allo-HSCT, children, Donor LymphocyteI Infusion
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic Donor lymphocytes infusionsBiological

    Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes arel freezed for next using. DLI is transfused to patients IV using central venous access.

    Donor lymphocytes infusion start from D+60 - D+100 and continue with escalating doses every 1.5-3 months during first year after HSCT up to appearance of GVHD or signs of disease. First dose is 1*10*6 CD3+/kg. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1*10*8 CD3+/kg.

  • Preventive Donor lymphocytes infusionsBiological

    Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes freeze for next using. DLI are transfused to patients IV using central venous access.

    Donor lymphocytes infusion continue with escalating doses every 1.5-3 months up to achieving MRD negative status or appearance of GVHD or signs of active disease.

    First dose is 1*10*6 CD3+/kg for patients without previous GVHD and 1*10*5 CD3+/kg for patients with previous GVHD. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1*10*8 CD3+/kg.

Study groups in NCT05009719
Study groupRoleWhat they receive
ProphylacticExperimentalThe patients with high risk of relapse of disease and full donor chimerism after allo-HSCT without signs of the disease will be include in this group.
Receives: Biological: Prophylactic Donor lymphocytes infusions
PreventiveExperimentalThe patients with persisted minimal residual disease or cytogenetic relapse after allo-HSCT will be include in this group.
Receives: Biological: Preventive Donor lymphocytes infusions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse - free survival

    Estimate time to morphological relapse by Kaplan Mayer

    Measured: 24 months

Secondary outcomes (8)

  1. Overall survival analysis

    Estimate time to death by Kaplan Mayer

    Measured: 24 months

  2. Relapse rate analysis

    Cumulative incidence of patients with relapse by Gray's test

    Measured: 24 months

  3. Non-relapse mortality analysis

    Cumulative incidence of patients with mortality without hematological relapse of malignancy

    Measured: 24 months

  4. Incidence of acute GVHD grade II-IV

    Cumulative incidence of patients with acute GVHD II-IV grade by Gray's test

    Measured: 125 days

  5. Incidence of moderate and severe chronic GVHD

    Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria by Gray's test

    Measured: 24 months

  6. Incidence of achievement MRD negative status

    Cumulative incidence of patients with MRD positive status, who had responds to therapy Gray's test

    Measured: 24 months

  7. Relapse - free survival

    Estimate time to appearing of MRD or morphological relapse by Kaplan Mayer

    Measured: 24 months

  8. Graft - versus -host-disease free/relapse free survival

    Estimate time to date of III-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic immunosuppressive treatment, disease relapse or death from any other cause by Kaplan Mayer

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The patients in this study will be divided into 2 groups: prophylactic and preventive depending on indications. Patients without signs of disease with high risk of relapse will be included into prophylactic group. Patients with persistence minimal residual disease or cytogenetic relapse will be included into preventive group. Also, patients will move from the first group to second group, if the clinical status changes.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009719
Sponsor's protocol ID
hsct/dli
Status last verified
Jun 2024
First submitted
16 Aug 2021
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prophylactic Donor lymphocytes infusions and Preventive Donor lymphocytes infusions in people with Hematologic Malignancy, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse - free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.

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