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Lymphoma, Mantle-cell clinical trials

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NCT ID: NCT04802590 Recruiting - Clinical trials for Mantle Cell Lymphoma

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Start date: January 24, 2022
Phase: Phase 2
Study type: Interventional

The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age). Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years. The primary aim is to assess MRD status at 6 months in both arms.

NCT ID: NCT04775745 Recruiting - Clinical trials for Mantle Cell Lymphoma

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

Start date: July 19, 2021
Phase: Phase 1
Study type: Interventional

This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.

NCT ID: NCT04763083 Recruiting - Clinical trials for Mantle Cell Lymphoma

First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies

Start date: May 14, 2021
Phase: Phase 1
Study type: Interventional

NVG-111 is a bispecific antibody drug, having two "arms", one arm attaches to a substance on cancer cells called ROR1, the other arm attaches to the body's immune cells directing them to kill the cancer cells. This is the first clinical trial of the drug NVG-111, and will include patients with certain types of cancer including chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) mantle cell lymphoma (MCL), follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) in Group A. Subjects with solid tumours, focusing initially on stage IV non-small cell lung cancer (NSCLC) or malignant melanoma.

NCT ID: NCT04736914 Recruiting - Clinical trials for Mantle Cell Lymphoma

Zanubrutinib-based Induction and Maintenance Therapy in Young and Fit Patients With Untreated Mantle Cell Lymphoma

Start date: January 31, 2021
Phase: Phase 2
Study type: Interventional

This is a prospective, single-center, single-arm, phase II study of Zanubrutinib-based induction followed by ASCT and Zanubrutinib maintenance (2 years) or followed directly by Zanubrutinib maintenance without ASCT in young and fit patients with untreated MCL. There will be an initial safety run-in phase of 6 patients which will be closely monitored for the observed toxicities during cycle1 in, induction therapy. After completion of safety run-in phase, the investigator will assessed and decided whether to continue the trial as planned. If no unexpected toxicity has been observed, study will expand the sample size to further assess efficacy and safety. Total around 47 patients aged 18-65 years with previously untreated, Ann Arbor stage II-IV, histologically proven MCL will be enrolled to receive alternating 3 cycles R-CHOP + Zanubrutinib /3 cycles R-DHAOx induction. Totally 6 cycles in induction and every 21 days per cycle. Due to lack of published data about BTKi in combination with R-DHAOx, Zanubrutinib is only applied in cycle 1,3,5(R-CHOP), 160mg BID, d1-21, and not in combination with R-DHAOx Patients who achieve remission (≥PR) will be allowed to proceed to ASCT or maintenance. Whether ASCT or not depends on investigator's evaluation and discretion. In patients who do not achieve a remission at end of induction (treatment failure), no study specific treatment is defined; rather, the further salvage treatment is upon the discretion of investigators. Patients remain in study for progression and survival follow-up. Patients will receive Zanubrutinib maintenance for two years in case of remission at ASCT assessment or end of induction assessment. Zanubrutinib is applied oral 160mg BID, continuously for 2 year or until progressive disease, unacceptable toxicity or death, whichever comes first. The primary analysis will be performed after last-patient completes induction treatment.

NCT ID: NCT04735471 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Phase 1 Study of ADI-001 in B Cell Malignancies

GLEAN-1
Start date: March 4, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies.

NCT ID: NCT04626791 Recruiting - Clinical trials for Mantle Cell Lymphoma

Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.

NCT ID: NCT04624958 Recruiting - Clinical trials for Mantle Cell Lymphoma

Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance With Zanubrutinib for Newly-Diagnosed MCL

Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).

NCT ID: NCT04545762 Recruiting - Clinical trials for Mantle Cell Lymphoma

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Start date: September 11, 2020
Phase: Phase 1
Study type: Interventional

This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19)

NCT ID: NCT04491370 Recruiting - Clinical trials for Mantle Cell Lymphoma

Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

Start date: August 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.

NCT ID: NCT04484012 Recruiting - Clinical trials for Recurrent Mantle Cell Lymphoma

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Start date: December 31, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.