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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies

Pilot Study of Co-Infusion of Donor Lymphocytes Enriched With Regulatory T Lymphocytes With Ex-vivo CD3-Depleted Hematopoietic Stem Cell Graft for the Prevention of Graft-versus-Host Disease in Children With Hematopoietic and Lymphoid Tissue Neoplasms

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in particular, severe forms of acute and chronic GVHD, while preserving the immunological function of the graft. In the proposed concept, enrichment of the T graft with regulatory cells will reduce the risk of GVHD and preserve a sufficient number of T lymphocytes in the graft for the formation of protective anti-infective immunity in the early stages after HSCT. The combination of partial T depletion and pharmacological immunosuppression minimized in volume and duration will combine the advantages of T depletion (early engraftment, low risk of GVHD, low risk of organ complications) and pharmacological prophylaxis (restoration of anti-infective immunity).

Who May Be Eligible (Plain English)

Who May Qualify: 1. willing to sign a consent form signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years). 2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework 3. Planned HSCT from a haploidentical donor 4. The Karnofsky or Lansky score is more than 70% 5. expected to live at least 8 weeks 6. Heart function: ejection fraction of at least 40% 7. Consent to continue follow-up for 3 years Who Should NOT Join This Trial: 1. Acute viral hepatitis or acute HIV infection 2. Hypoxemia with SaO2 \<90% 3. Bilirubin \>3 normal 4. Creatinine \>3 norms 5. Pregnancy and lactation 6. Life-threatening infection 7. Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system) 8. Karnofsky score or Lansky score \<70% Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years). 2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework 3. Planned HSCT from a haploidentical donor 4. The Karnofsky or Lansky score is more than 70% 5. Life expectancy of at least 8 weeks 6. Heart function: ejection fraction of at least 40% 7. Consent to continue follow-up for 3 years Exclusion Criteria: 1. Acute viral hepatitis or acute HIV infection 2. Hypoxemia with SaO2 \<90% 3. Bilirubin \>3 normal 4. Creatinine \>3 norms 5. Pregnancy and lactation 6. Life-threatening infection 7. Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system) 8. Karnofsky score or Lansky score \<70%

Treatments Being Tested

DRUG

Cyclosporine A (CsA)

The combination of partial T depletion and pharmacological immunosuppression minimized in volume and duration will combine the advantages of T depletion (early engraftment, low risk of GVHD, low risk of organ complications) and pharmacological prophylaxis (restoration of anti-infective immunity).

DRUG

Sirolimus

Pharmacological prophylaxis of GVHD is one of the key subjects of evaluation in the current study. Since the optimal pharmacological approach is not known, the allocation of the patients to study groups will be by randomization procedure, although not for the purpose of direct comparison, but for unbiased descriptive analysis. There will be four main groups and an additional group to be open for allocation based on the main group closing for fitting the stopping rules. The details of pharmacological GVHD prevention are Sirolimus 1 mg -3 till +30 4-8 ng/ml

DRUG

Ruxolitinib (JAKAVI®)

Pharmacological prophylaxis of GVHD is one of the key subjects of evaluation in the current study. Since the optimal pharmacological approach is not known, the allocation of the patients to study groups will be by randomization procedure, although not for the purpose of direct comparison, but for unbiased descriptive analysis. There will be four main groups and an additional group to be open for allocation based on the main group closing for fitting the stopping rules. The details of pharmacological GVHD prevention regimens are Ruxolitinib 5 mg -2 till +30

DRUG

Abatacept

Pharmacological prophylaxis of GVHD is one of the key subjects of evaluation in the current study. Since the optimal pharmacological approach is not known, the allocation of the patients to study groups will be by randomization procedure, although not for the purpose of direct comparison, but for unbiased descriptive analysis. There will be four main groups and an additional group to be open for allocation based on the main group closing for fitting the stopping rules. Abatacept 10 mg/kg -1, +7, +14, +28

Locations (1)

National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
Moscow, Russia