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The intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD, PET-CT scan), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen (chidamide, prednisone, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection chemotherapy (methotrexate, cytarabine, dexamethasone), radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.

Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ALL-LBL protocol.

Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.

vincristine

CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.

IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.

PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.

Adriamycin will be added to Consolidation-Module of PDT-ALL-LBL protocol.

Adriamycin

Methotrexate will be added to Consolidation-Module of PDT-ALL-LBL protocol.

Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.

6-mercaptopurine.

VP-16 will be added to Consolidation-Module of PDT-ALL-LBL protocol.

AraC will be added to Consolidation-Module of PDT-ALL-LBL protocol.

Bone marrow aspiration and additional tests will be performed in all module of PDT-ALL-LBL protocol.

Bone marrow aspiration

Intrathecal injection of chemotherapy will be performed in PDT-ALL-LBL protocol.

Intrathecal injection

Radiation therapy will be performed for mediastinum and/or central nervous system leukemia/lymphoma in PDT-ALL-LBL protocol.

Radiation therapy

Next-Generation-Sequencing (NGS) will be performed in PDT-ALL-LBL protocol.

Allo-HSCT will be added to LBL patients with available donor in PDT-ALL-LBL protocol.

allogeneic hematopoietic stem cell transplantation

Flow-MRD will be added to PDT-ALL-LBL for bone marrow and cerebrospinal fluid samples.

Flow-MRD

FISH will be added to PDT-ALL-LBL for bone marrow samples.

FISH

Flow immunophenotyping will be performed in PDT-ALL-LBL protocol.

Flow immunophenotyping

Karyotyping will be performed in PDT-ALL-LBL protocol.

Karyotyping

HDACi chidamide will be added to induction regimen, consolidation and maintenance module of PDT-ALL-LBL.

Chidamide

PET-scan will be performed for T-LBL patients for MRD assessment in PDT-ALL-LBL.

PET-CT scan

Hongsheng Zhou

Qifa Liu, MD

Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.

T-lymphoblastic lymphoma/leukemia is a neoplasm of lymphoblasts committed to the T-cell lineage, typically composed of small to medium-sized blast with scant cytoplasm, moderately condensed to dispersed chromatin, and inconspicuous nucleoli, involving bone marrow and blood or presenting with primary involvement of the thymus or of nodal or extranodal sites. T-ALL/LBL is generally considered a higher-risk disease than B-ALL. Compared to B-ALL, T-LBL/ALL is associated with a higher risk of induction failure, early relapse, and isolated CNS relapse.

Chidamide is a novel oral HDACi with promising activity in non-Hodgkin lymphoma (NHL). Chidamide, a new oral isotype-selective HDACi, approved in China for the treatment of R/R PTCL in December 2014. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, two-arm, multi-site trial PDT-ALL-LBL is aimed to evaluate the safety and effect of oral histone deacetylase inhibitor chidamide for adult T-ALL/LBL. Compared to PDT-ALL-2016 for B-ALL, HDACi chidamide will be administrated from induction therapy to maintenance therapy, along with higher dose of consolidation regimen of cytarabine, methotrexate, cyclophosphamide.

The intervention of PDT-ALL-LBL consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide, dexamethasone, vincristine, cyclophosphamide, Idarubicin, pegaspargase), consolidation regimen (chidamide, prednisone, cytarabine, methotrexate, cyclophosphamide, etoposide, adriamycin, 6-mercaptopurine, pegaspargase), MRD assessment (MRD1/d14, MRD2/d24, MRD3/d45, MRD4/pre-allo-HSCT) and maintenance regimen (chidamide, vincristine, methotrexate, 6-mercaptopurine), intrathecal injection, radiation therapy (for mediastinum- and/or central nervous system-involved lymphoma/leukemia) and allogeneic hematopoietic stem cell transplantation for patients with donor.

Induction Regimen-Pretreatment: dexamethasone, -3d to 0d; Induction regimen VICLD: VCR: d1, d8, d15, d22; IDA: d1, d8; CTX: 1g/m2, 1; PEG-asp: 2000-2500IU/m2, 1, 15; dexamethasone: 1-24; chidamide: 10mg/d, po, qd. Flow-based MRD assessment: d14, d24 during induction regimen, d45, and pre-HSCT. Salvage regimen VLCAM (MRD1/d24\>1%): CTX, d25; AraC 50mg/m2, d25-31; 6-MP: 25-31, PEG-asp: 2500IU/m2, d26. Consolidation Module (CM)-CM1: AraC 3g/m2, q12h, d1-2, Dex: 10mg/m2, d1-2, PEG-asp: 2, 6-MP: d1-7, chidamide, po qd; CM2: MTX 5g/m2, 1, Dex: 10mg/m2, 1-2, PEG-asp: d2, 6-MP: 1-7, chidamide, po qd; CM3: CTX 1g/m2, 1-3, PEG-asp: 2, 6-MP: 1-7, chidamide, po qd. CM4-6: repeat CM 1-3. Re-Induction: VICLD after CM6. CM7-9: repeat CM1-3. Allo-HSCT: after CM3 when matched-related-donor (MRD), haploidentical related donor (HRD) or matched-unrelated-donor (MUD) available. Non-allo-HSCT: finish CM4-9 and CPOMP maintenance. Maintenance Module-CPOMP: chidamide, po qd for 24 months; Pred: for 12 months; VCR for 12 months; MTX: for 24m months; 6-MP for 24 months.

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL

An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia

3 years EFS of LBL/ALL patients enrolled in PDT-ALL-LBL

MRD after induction regimen of PDT-ALL-LBL protocol

CR after induction regimen of PDT-ALL-LBL protocol

Dearth during induction regimen of PDT-ALL-LBL

AE of 3 years of LBL patients enrolled in PDT-ALL-LBL

Cumulative incidence relapse rate of 3 years of LBL patients enrolled in PDT-ALL-LBL protocol

3 years RFS of LBL patients enrolled in PDT-ALL-LBL protocol

3 years OS of LBL patients enrolled in PDT-ALL-LBL protocol

Nanfang Hospital, Southern Medical University

M.D., Professor

Diseases and Abnormalities at or Before Birth

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Children with malignant hemopathies attending a precision exercise training

Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training

Sport Therapy

Francesca Lanfranconi, MD, PhD

Adriana Balduzzi, MD, PhD

Adriana Balduzzi

Andrea Biondi, MD, PhD

In the early years of life and during adolescence, physical activity is crucial for good development of motor skills. It is even more so for those children and young people who are forced to undergo anti-cancer therapies and therefore undergo long periods of hospitalization (often bedridden) and prolonged periods of physical inactivity.

The research project "Sport Therapy" was born with the aim of demonstrating that, through targeted physical activity administered by the sports physician in collaboration with the pediatrician hematologist, it is possible to facilitate the full recovery of these patients, avoiding the high risk of chronic diseases related to a sedentary lifestyle and allowing them to better reintegrate, once healed, in their community of origin (school, sport and social relations).

The research project "Sport Therapy" was born within the Maria Letizia Verga Center at the Pediatric Clinic of the University of Milan Bicocca, at the Foundation for the Mother and Her Child, San Gerardo Hospital in Monza. Every year, around 80 children and adolescents with leukemia, lymphoma or blood disorders leading to bone marrow transplantation are treated here.

State of the art. Today, thanks to the progress made in the early diagnosis and treatment of cancer, there are more than 300 thousand young patients in Europe who have been cured of pediatric cancer, and by 2020 there will be almost half a million . For these children and young people, having the opportunity to perform targeted physical activity during treatment plays a key role in preventing diseases due to physical inactivity, which are one of the worst and most widespread consequences for healed patients.

Children and adolescents suffering from cancer of the blood, because of the therapies to which they are subjected, suffer a progressive reduction in respiratory and cardiac capacity, as well as muscle strength. Targeted physical exercise is a possible therapeutic approach to solving their significant problems of reduced ability to perform exercise. It is possible to administer this type of therapy thanks to the synergy created by the collaboration between pediatricians, hematologists, and sports physicians.

Why is this research important? For at least three reasons:

1. the results of the "Sport Therapy" research project will launch precision training as one of the therapeutic weapons available to combat the consequences of hematological diseases in childhood;
2. by increasing the physical capacity of children and adolescents with malignant hemopathies during the phases of cancer treatment, the investigators will reduce the heavy legacy left by treatment, thus bridging the gap regarding their disadvantage towards healthy peers and ensuring their full reintegration into their communities (school, sport, social relations);
3. a standardization of the methodology for using precision exercise in hospitalized children and adolescents will facilitate the monitoring of the progress of these type of interventions at the international level and the data from the "Sport Therapy" project will allow governments and concerned bodies not to further postpone the establishment of strategies necessary to improve the health and welfare of people cured of cancer diseases.

Innovative aspects of research. At the end of the research project "Sport Therapy":

* new strategies will be available to combat cardiopulmonary and skeletal muscle damage resulting from anticancer therapies;
* it will be definitively demonstrated how, from the very beginning of the disease, physical exercise can be a therapeutic option and not just a decorative element in the critical process of caring for children and adolescents suffering from oncological blood diseases, from the beginning of the disease;
* the possibility of introducing new technical figures in the hospital context will be clear. Sports medicine physician and exercise physiologists will be part of the multidisciplinary team that connects the hospital environment to the territory;
* the future perspective, once the experimentation has been completed and the effectiveness of the precision training intervention on the psycho-physical health of children and adolescents suffering from cancer has been demonstrated, will be to make "Sport Therapy" a permanent care service during the treatment of patients of developing age.

Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)

Precision Exercise in Children With Malignant Hemopathies

Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project

Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols

Maximal O2 uptake and skeletal muscle O2 extraction

The PedsQL Measurement Model is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales (physical, emotional, social, school) and 3 Summary Scores (physical health, psycho-social health and total). Each item has a score between 0 and 4, so the scale score is between 0-100. Higher scores indicate a better QoL.

Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.

Comitato Maria Letizia Verga,Italy

University of Milano Bicocca

Leukemia-Lymphoma, Adult T-Cell

Adult T-cell Leukemia/lymphoma

Fludarabine

Fludarabine phosphate

Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

CD7 CART

Peihua MD Lu, PhD

Jianqiang MD Li, PhD

Peihua Lu, MD/PhD

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells

To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

In the presence of extramedullary lesions, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe extramedullary lesions

the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method

percentage of CD7 CAR- T cells measured by flow cytometry method

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

the peak concentration of Senl-T7 CAR-T cells amplified in the peripheral blood (Cmax, detected by flow cytometry and qPCR); the time taken to reach the peak concentration (Tmax), and the persistent time of the Senl-T7 CAR-T cells in vivo in patients

the pharmacodynamic change in the clearance of peripheral blood CD7+ cells and the release of the cytokines at each observation time point

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL	NCT03564704	Leukemia Leukemia, Acute Adult Lymphobla... Leukemia, Lymph... Leukemia, T Cel... Adult Acute Lym... Lymphoblastic L... Lymphoblastic L...	Dexamethasone vincristine Cyclophosphamid... Idarubicin Pegaspargase Adriamycin Methotrexate 6-mercaptopurin... Etoposide Cytarabine Bone marrow asp... Intrathecal inj... Radiation thera... NGS allogeneic hema... Flow-MRD FISH Flow immunophen... Karyotyping Chidamide PET-CT scan	14 Years - 55 Years	Nanfang Hospital, Southern Medical University
Precision Exercise in Children With Malignant Hemopathies	NCT04090268	Leukemia, Myelo... Leukemia, B-cel... Leukemia, T Cel... Lymphoma, Hodgk... Lymphoma, Non-H... Drepanocytosis Thalassemia Maj... Adrenoleukodyst...	Sport Therapy	2 Years - 18 Years	University of Milano Bicocca
Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells	NCT04938115	Leukemia, T Cel...	CD7 CART	2 Years - 70 Years	Hebei Senlang Biotechnology Inc., Ltd.
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL	NCT03553238	Leukemia, Acute Leukemia, T Cel... Leukemia, Lymph...	Chidamide Dexamethasone vincristine Cyclophosphamid... Idarubicin Pegaspargase Adriamycin Methotrexate 6-Mercaptopurin... Etoposide Cytarabine Bone marrow asp... Intrathecal inj... Radiation thera... NGS allogeneic hema... Flow-MRD FISH Flow immunophen... Karyotyping	14 Years - 55 Years	Nanfang Hospital, Southern Medical University
Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL	NCT03553238	Leukemia, Acute Leukemia, T Cel... Leukemia, Lymph...	Chidamide Dexamethasone vincristine Cyclophosphamid... Idarubicin Pegaspargase Adriamycin Methotrexate 6-Mercaptopurin... Etoposide Cytarabine Bone marrow asp... Intrathecal inj... Radiation thera... NGS allogeneic hema... Flow-MRD FISH Flow immunophen... Karyotyping	14 Years - 55 Years	Nanfang Hospital, Southern Medical University
Precision Exercise in Children With Malignant Hemopathies	NCT04090268	Leukemia, Myelo... Leukemia, B-cel... Leukemia, T Cel... Lymphoma, Hodgk... Lymphoma, Non-H... Drepanocytosis Thalassemia Maj... Adrenoleukodyst...	Sport Therapy	2 Years - 18 Years	University of Milano Bicocca

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