Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Prednisone

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

They will be treated with a single dose of rituximab 375mg/m2, once, by intravenous infusion 3-10 days prior to initiation of planned R-CHOP-like chemoimmunotherapy, and prednisone 50mg to 100 mg (preferred dose is 100mg) PO daily for 5-7 days (preferred duration is 7 days) of the 14 days prior to initiation of planned R-CHOP, R-EPOCH or R-CEPP chemoimmunotherapy. Pre-phase therapy may be given in either the inpatient or outpatient setting. After completion of a single course of pre-phase rituximab and prednisone as described above, further treatment will be according to the choice of the attending physician, in accordance with appropriate medical practice. It is expected, based on the inclusion criteria, that patients enrolled on the pre-phase arm will most often receive initial therapy consisting of R-CHOP, R-EPOCH or RCEPP chemoimmunotherapy for ≥ 2 cycles, but alternative therapies as deemed appropriate by the treating physician will not be considered violations of this protocol.

Patients enrolled on the GA only arm of the study will be treated according to the choice of the attending physician. This arm of the study is non-therapeutic.

rituximab

prednisone

Geriatric Assessment

Paul Hamlin, MD

This study will evaluate the ability of a largely self-administered geriatric assessment (GA) to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving chemotherapy or chemoimmunotherapy.

Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy

Hospitalization during or within 30 days following chemotherapy Dose delay or reduction to a dose intensity ≤80% of the planned dose intensity. Dose reductions occurring prior to cycle 1 of chemotherapy will be counted as events. Discontinuation of chemotherapy due to toxicity Grade 3 or higher non-hematologic toxicity Grade 4 or higher hematologic toxicity. Using the NCI CTCAE v4.0 toxicity grading

Memorial Sloan Kettering Cancer Center

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hodgkin Disease

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01

Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)

non intervational

Shai Yarkoni, MD

Tsila Zuckerman, MD

This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study.

Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.

Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.

Cellect Biotechnology

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Prolymphocytic

Leukemia, Prolymphocytic, T-Cell

Lymphoma, T-Cell, Cutaneous

Leukemia, Large Granular Lymphocytic

Leukemia, T-Cell

Peripheral T-cell Lymphoma

T-cell Prolymphocytic Leukemia

Cutaneous T-cell Lymphoma

Aggressive NK Cell Leukemia

T-cell Large Granular Lymphocyte Leukemia

Pharmaceutical Solutions

KT-333 will be supplied as 10mg/mL concentration frozen solution to be administered intravenously per the protocol defined frequency and dose level.

KT-333

Lauren Pinter Brown, MD

Dana Haycraft

Cesar Figueras, MBA, HRM, BSN, RN

Elizabeth McCarthy, MSN, RN

Joel Victor

Abby Reed

Lily Yang

John Reneau, MD,PhD

Heather Yost

Pierluigi Porcu, MD

Andrew Schumacher

Auris Huen, MD

Oluwakemi Awolowo

Mark Dewey

Enrica Marchi, MD

Stephen Smith, MD

Ashwin Gollerkeri, MD

This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L), T-cell prolymphocytic leukemia (T-PLL), and Solid Tumors. The Phase 1a stage of the study will explore escalating doses of single-agent KT-333. The Phase Ib stage will consist of 4 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), LGL-L, and solid tumors.

This is an open-label Phase 1a (dose escalation)/1b (dose expansion) first-in-human study of KT-333 in adult patients. Patients with relapsed/refractory (R/R) lymphomas, LGL-L, T-PLL, and solid tumors will be enrolled in Phase 1a. Phase 1b will consist of separate cohorts of patients with R/R PTCL, CTCL, LGL-L, and solid tumors.

Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-333 in Adult Patients With Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors

Incidence and severity of adverse events as assessed by CTCAE v5.0 Phase 1a/1b

Incidence and severity of clinical laboratory abnormalities in Serum Chemistry, Hematology, Coagulation Parameters and urinalysis tests as assessed by CTCAE v5.0 Phase 1a/1b

Changes in the ECG parameters, including heart rate and measures PR, QRS, QT, and QTc intervals as assessed by CTCAE v5.0 Phase 1a/1b

To establish the Maximum Tolerated Dose (MTD) Phase 1a

Number of Participants with protocol specified Dose Limiting Toxicities (DLTs) Phase 1a

Area under the plasma concentration versus time curve for KT-333 from time to zero to last quantifiable time point (AUC 0-t ) Phase 1a/1b

Maximum Plasma Concentration of KT-333 (Cmax)

Time of maximum plasma concentration of KT-333 (Tmax) Phase 1a/1b

Half-life of KT-333 if data permits (T1/2) Phase 1a/1b

Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t) Phase 1a

Evidence of clinical activity of KT-333 as determined by Objective Response Rate (ORR) as per Lugano criteria 2014 for Lymphomas Phase 1a/1b.

Evidence of clinical activity of KT-333 as determined by RECIST 1.1 to determine ORR , complete response (CR), partial response (PR) for solid tumors Phase 1a/1b.

Evidence of clinical activity of KT-333 as determined by ORR by Modified Severity-Weighted Assessment Tool (mSWAT) for Cutaneous T-Cell Lymphoma (CTCL) Phase 1a/1b

Evidence of clinical activity of KT-333 as determined by ORR by investigator assessment for Large Granular Lymphocytic Leukemia (LGL-L) Phase 1a/1b

Evidence of clinical activity of KT-333 as determined by ORR based on T-PLL International Study Group criteria, Phase 1a

Kymera Therapeutics, Inc.

only patients with diffuse large B-cell lymphoma

only patients with small lymphocytic lymphoma / chronic lymphocytic leukemia

only patients with marginal zone lymphoma

only patients with B-lymphomas not described above

only patients with all types of T-cell lymphoma

Marek Trneny, prof. MD

David Belada, MD

Marek Trneny, prof.MD

The Czech National Lymphoma Registry (NiHiL) was founded to monitor epidemiologic data and improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s lymphoma (NHL).

The patients are registered into the registry in anonymized form. For each patient are available: registration form, diagnostic form, treatment form, follow- up form, and other malignancy form.

Data quality in the NiHiL has been checked by audits. The data is analyzed according to NHL subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS, DFS, Lymphoma specific survival, longterm toxicity.

The Czech National Lymphoma Registry (NiHiL) was established in 1999 in order to monitor epidemiologic data and to improve the diagnostic evaluation and quality of treatment of patients with non-Hodgkin´s lymphoma (NHL). The database NiHiL includes majority of patients with NHL in the Czech Republic, treated in one of seven University Hospitals and other smaller centres. This represents approx. 75% of all lymphoma patients in the Czech Republic. Since 1999 until the end of year 2016 there were registered 14000 pts.

The patients are registered into the registry in anonymized form at the time of diagnosis after signing informed consent and data are updated/collected at the end of first line treatment, at each relapse including therapy for relapse and then annual follow-up and at the time of death. The registration is submitted electronically via secure internet system. For each patient are available following forms: registration form, diagnostic form, treatment form, follow- up form, and other malignancy form. The content of diagnostic form consists of diagnosis according WHO classification including the copy of original histology description, date of diagnosis, clinical stage, B symptoms, nodal and extranodal involvement, laboratory findings and prognostic systems (IPI, aaIPI, MIPI, FLIPII and others). The prognostic system is calculated automatically. The diagnostic form is the same for the first diagnosis and for the relapses. The treatment form consists of detailed information on the treatment: chemotherapy regimens, therapy with monoclonal antibodies, radiotherapy, autologous or allogeneic transplant. Response assessment has been adjusted to the different version of Chesson criteria for malignant lymphoma. It is expected that comorbidity score and toxicities evaluation will be added into the therapeutic form too.

The follow-up form is requested to be updated annually, besides that in case of relapse or death. This form includes information about clinical status, date of relapse or death.

The exports made from NiHiL content all data from registry and survival data (overall survival, progression survival and disease free survival).

Data quality in the NiHiL has been checked by audits recently, which have been carried out in each centre twice a year.

The data is analyzed according to NHL subtypes with endpoints: lymphoma distribution, epidemiological data, prognostic characteristic, treatment characteristics, response rate, relapse rate, mortality, PFS, OS, DFS, Lymphoma specific survival, longterm toxicity.

The registry has been repeatedly supported by the grants of Ministry of Health. A substantial number of papers originated from the NiHiL have been published in last 15 years in both Czech and international journals. The main aim of the registry is to collect data for malignant lymphoma for better understanding of epidemiological and clinical data about this disease.

Non-Hodgkin Lymphoma - Observational Epidemiological and Clinical Study (NiHiL)

The Incidence, Epidemiology, Clinical Characteristic, Prognostic Factors, Therapy and Outcome of Non-Hodgkin Lymphoma Patients in the Czech Republic. NiHiL- Longitudinal Observational Study of Czech Lymphoma Study Group (CLSG)

Individual participant data are available only for reasearchers in CLSG.

occurrence and study of factors influencing the formation of non-hodgkin´s lymphoma from data filled into registry forms by physicians and datamangers

patients clinical characteristics from data filled into registry forms by physicians and datamangers (values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number of extranodal localizations will be combined to report IPI /International prognostic index/; other prognostic risk factors will be calculated similarly)

patients biological characteristics from data filled into registry forms by physicians and datamangers (immunohistochemical differences of non-hodgkin´s lymphomas, e.g. GC-like or non GC-like phenotype of DLBCL)

evaluation of prognostic factors based on subtypes of lymphoma from data filled into registry forms by physicians and datamangers

type of therapy - induction or following therapy - for all patients from data filled into registry forms by physicians and datamangers

Overall response is measured according to Revised Response Criteria For Malignant Lymphoma (Cheson BD et al, JCO 2007; the main examinations PET/CT and bone marrow biopsy) for all patients, who can be evaluated

Czech Lymphoma Study Group

Hematologic Neoplasms

Etoposide

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Etoposide phosphate

All patients will be treated with 1 injection of CD19-UCART. Three escalating dose-levels (1.0-2.0x10\^6/kgBW, 2.5-5.0x10\^6/kgBW, 5.5-10.0x10\^6/kgBW) of CD19-UCART will be evaluated using a 3+3 design. Each CD19-UCART injection will be administered at Day 0.

A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.

CD19-UCART

Yi Zhang, Professor

He Huang, Professor

The purpose of this study is to evaluate the safety and efficacy of ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.

CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC.This is a open-label, dose estilation study to evaluate the safety and anti-tumor efficacy of CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.

Safety and Efficacy Evaluation of CD19-UCART

A Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

The number of UCART cells surviving in the body within 90 days after receiving the study drug;

The time from treatment with study drug to tumor progression or death.

the time from treatment with study drug to death by any cause.

Adverse events assessed according to NCI-CTCAE v5.0 criteria

The total response rate after 90 days of treatment with study drug (overall response rate for ALL= CR+CRi; for NHL=CR+PR);

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy	NCT01829958	Non Hodgkin Lym... Diffuse Large B...	rituximab prednisone Geriatric Asses...	60 Years -	Memorial Sloan Kettering Cancer Center
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study	NCT03260101	Acute Myelogeno... Acute Lymphobla... Non Hodgkin Lym... Hodgkin Lymphom...	non intervation...	18 Years - 70 Years	Cellect Biotechnology
Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy	NCT01829958	Non Hodgkin Lym... Diffuse Large B...	rituximab prednisone Geriatric Asses...	60 Years -	Memorial Sloan Kettering Cancer Center
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study	NCT03260101	Acute Myelogeno... Acute Lymphobla... Non Hodgkin Lym... Hodgkin Lymphom...	non intervation...	18 Years - 70 Years	Cellect Biotechnology
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study	NCT03260101	Acute Myelogeno... Acute Lymphobla... Non Hodgkin Lym... Hodgkin Lymphom...	non intervation...	18 Years - 70 Years	Cellect Biotechnology
Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors	NCT05225584	Non Hodgkin Lym... Peripheral T-ce... Cutaneous T-Cel... Large Granular ... T-cell Prolymph... Solid Tumors	KT-333	18 Years -	Kymera Therapeutics, Inc.
Non-Hodgkin Lymphoma - Observational Epidemiological and Clinical Study (NiHiL)	NCT03199066	Non Hodgkin Lym...		18 Years -	Czech Lymphoma Study Group
Safety and Efficacy Evaluation of CD19-UCART	NCT03229876	Acute Lymphobla... Non Hodgkin Lym...	CD19-UCART	1 Year - 65 Years	Bioray Laboratories

Spots Global Cancer Trial Database for non hodgkin lymphoma (nhl)