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Immune System Diseases

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Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

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Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

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Immunoproliferative Disorders

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Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

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Immunologic Factors

* Collection of blood samples will be done in newly diagnosed relapse of B-ALL children at the time of relapse diagnosis.
* Children aged from 1 to 18 years at the time of first B-ALL relapse diagnosis.

* Collection of blood samples will be done at the same stage of treatment as the relapse group has been collected.
* Children aged from 1 to 18 years enrolled into FRALLE (protocol of treatment) or EORTC (European Organisation for Research and Treatment of Cancer) treatment protocols, treated for B-ALL and who are in complete molecular remission.
* These control patients will be recruited at the same time from the beginning of B-ALL treatment as paired-relapsed control patients.

Collection of blood samples

Isabelle PELLIER, PU-PH

B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.

Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

Comparison of the immune status of patients at the diagnosis of their first relapse diagnosis with those of children treated for B-ALL who are in complete remission and at the same stage of treatment.

University Hospital, Angers

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Graft vs Host Disease

Syndrome

Bronchiolitis

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Pneumonia

Organizing Pneumonia

Bronchitis

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases, Obstructive

Lung Diseases

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Bronchiolitis Obliterans Organizing Pneumonia

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Dermatologic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Cyclosporine

Cyclosporins

Mycophenolic Acid

Thymoglobulin

Busulfan

Antilymphocyte Serum

ATG 10.0mg/kg group refers to treatment with ATG in the total dose of 10.0mg/kg.

ATG 12.5mg/kg group refers to treatment with ATG in the total dose of 12.5mg/kg.

ATG will be intravenously infused via a central venous catheter in 4 or 5 days, from day -4 or -3 until day 0. The other conditioning drugs administered before transplantation include fludarabine (Flu), busulfan (Bu),cyclophosphamide (Cy). All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF) for aGVHD prevention.

Jianghui xu, Dr

Bingyi Wu, MD

In this study, a randomized, prospective, multicenter, open cohort study was conducted to investigate patients with acute leukemia (14～60-year-old) with different ATG doses (10 mg / kg and 12.5 mg / kg ) in fludarabine, busulfan, cyclophosphamide and antilymphocyte globulin (FBCA) pretreatment protocol of Haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The purpose is to compare the incidences of chronic graft vs host disease (cGVHD) in haplo-HSCT recipients receiving different dose ATG and one year leukemia relapse after transplantation. The main objective was to investigate the optimal dose of ATG for decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to improve the quality of life of patients with haplo-HSCT.

Human leukocyte antigen (HLA) haploidentical hematopoietic stem cell transplantation is an effective method for the treatment of hematological malignancies. However, high incidence rate of graft-versus-host disease (GVHD) seriously affects the quality of life of patients.

Using ATG in vivo T cell transplantation regimens reduce the rate of acute GVHD (aGVHD) and cGVHD. However, the optimal dose of ATG is unknown, Huang's reported that a prospective, randomized trial, which compared the long-term outcomes of 2 ATG doses used in myeloablative conditioning before unmanipulated haplo-HSCT. Patients were received 10 mg/kg or 6 mg/kg of ATG in conditioning regimen. The 5-year cumulative incidence of cGVHD was found to be higher with ATG 6mg/kg (75.0% vs 56.3% \[P = .007\] and moderate-to-severe cGVHD: 56.3% vs 30.4% \[P\<.0001\]. ATG 10mg/kg in conditioning regimen was found to be associated with a lower risk of cGVHD. But the moderate-to-severe cGVHD was as high as 35%. We established the FBCA pretreatment regimen which added ATG and achieve the goal of reducing GVHD. In this FBCA pretreatment regimen the ATG dose was 12.5mg/kg which higher than that of other protocol. The cumulative incidence of grades II-IV aGVHD and cGVHD was 21.9% and 14.3% with the 12.5mg/kg ATG in the FBCA conditioning regimen which was lower than that of ATG 10mg/kg reported by Huang. However, ATG may lead to immunosuppression and lead to slow recovery of immune function and increased infection rate and may increase leukemia relapse after transplantation. What is the optimal does of ATG in FBCA pretreatment regimen which could reduce cGVHD and not increase leukemia relapse after transplantation? Access to ClinicalTrials and other sites found that there was still no related international studies with the FBCA conditioning regimen. We hypothesize that total ATG dose 12.5mg/kg in FBCA pretreatment regimen will decrease cGVHD and not increase leukemia relapse post transplantation.

In this study, a randomized, prospective, multicenter, open cohort study was conducted to investigate patients (14～60-year-old) with different ATG doses (10 mg / kg and 12.5 mg / kg ) in the FBCA pretreatment protocol of haploidentical hematopoietic stem cell transplantation. The purpose of this study is to compare the incidences of cGVHD and one year leukemia relapse in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis The first objective was to investigate the optimal dose of ATG for decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to improve the quality of life of patients with HLA haploid hematopoietic stem cell transplantation.

A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT

A Randomized,Open,Multicenter and Prospective Study of the Optimized Dose of Anti-Thymoglobuline in Haploidentical Allogeneic Stem Cell Transplantation

individual participant data are to be shared with other researchers, when it will be available and be obtained by web.

chronic GVHD diagnosis based on National Institutes of Health (NIH) criterion

leukemia relapse base on morphology criterion

acute GVHD diagnosis based on NIH criterion

Nanfang Hospital, Southern Medical University

First Affiliated Hospital, Sun Yat-Sen University

Second Affiliated Hospital, Sun Yat-Sen University

Zhujiang Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia	NCT02618109	B Acute Lymphob... Leukemia Relaps...	Collection of b...	1 Year - 18 Years	University Hospital, Angers
A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT	NCT03190733	Chronic Graft-v... Leukemia Relaps...	ATG	14 Years - 60 Years	Zhujiang Hospital
A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT	NCT03190733	Chronic Graft-v... Leukemia Relaps...	ATG	14 Years - 60 Years	Zhujiang Hospital

Spots Global Cancer Trial Database for leukemia relapse