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Leukemia, Lymphoid clinical trials

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NCT ID: NCT05140369 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

CLL Therapy Approaches in Russia

CLL registry
Start date: October 29, 2021
Phase:
Study type: Observational [Patient Registry]

This is going to be a non-interventional study (NIS). Assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. Patients should be enrolled into study after evaluation of eligibility criteria by the investigator. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). It is planned to enroll approximately 6000 patients (suggested number of patients on WW~1000 pts, 1L~2750 pts, RR~2250 pts) During the course of study's prospective part, it is planned to carry out at approximately 5 visits: (if unscheduled visit performed - the information should be filled on nearest visit). - Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site. - Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis). - Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update).

NCT ID: NCT05137860 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

Start date: December 12, 2021
Phase: Phase 4
Study type: Interventional

Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.

NCT ID: NCT05136378 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia Stage A(0)

Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients without Indication of Chemotherapy

NCT ID: NCT05133310 Recruiting - Sepsis Clinical Trials

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Start date: November 19, 2021
Phase: Phase 4
Study type: Interventional

In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.

NCT ID: NCT05127148 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia, Adult

RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL

Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.

NCT ID: NCT05105867 Recruiting - Clinical trials for Relapsed or Refractory B-cell Non-hodgkin Lymphoma

CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

Start date: September 29, 2021
Phase: Early Phase 1
Study type: Interventional

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

NCT ID: NCT05099068 Recruiting - Glioblastoma Clinical Trials

Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)

PLANET
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

NCT ID: NCT05091424 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Start date: March 7, 2022
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.

NCT ID: NCT05082519 Recruiting - Obesity Clinical Trials

Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL

IDEAL2
Start date: March 12, 2022
Phase: Phase 2
Study type: Interventional

This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight. This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.

NCT ID: NCT05069051 Recruiting - Clinical trials for Chronic Lymphoid Leukemia in Relapse

Belimumab in Patients With Chronic Lymphocytic Leukemia

BeliVeR
Start date: January 19, 2022
Phase: Phase 2
Study type: Interventional

This study is a phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia (CLL). Treatment of CLL has drastically changed in the past years as new therapeutic agents have gained clinical approval. The combination rituximab/venetoclax over a course of two years is approved as second line therapy especially in patients with high risk CLL (del17p), showing high remission rates and achievement of MRD (minimal residual disease) negativity. The next goals in CLL therapy are now to increase the rate of MRD negativity and to achieve an earlier MRD negativity during the course of treatment to allow for a reduction of treatment time and therefore treatment-induced toxicities. In line with other hematologic diseases, progression free survival depends on remission status, especially MRD negativity, after last treatment as MRD positivity after therapy indicates the persistence of treatment resistant CLL cells. One mechanism of therapy resistance has been described as reduced sensitivity to rituximab-induced antibody dependent cell-mediated cytotoxicity (ADCC) by natural killer (NK) cell production of B-lymphocyte stimulator (BlyS, also called BAFF), which can be bound by belimumab, a human anti-BAFF antibody. Moreover, recombinant human (rh)BAFF can dose dependently reverse cytotoxic effects of venetoclax, which could also be restored by the application of belimumab. This led to the conceptualization of this clinical trial, in which belimumab is applied as a weekly subcutaneous injection in combination with standardrituximab/venetoclax treatment for up to 24 months in relapsed and refractory CLL patients. By removing BAFF from the CLL microenvironment we aim to increase the efficacy of rituximab/venetoclax treatment to achieve higher and earlier MRD negativity rates and allow for an abbreviated treatment.