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Neoplasm, Residual clinical trials

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NCT ID: NCT04785547 Terminated - Clinical trials for Minimal Residual Disease

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Start date: December 17, 2020
Phase: Phase 2
Study type: Interventional

An add-on phase II trial within the ALL SCTped 2012 FORUM with the primary objective to determine whether the use of Blincyto in paediatric patients with B-lineage ALL and pre- and/or post-transplant MRD could induce MRD-negativity in patients who were MRD-positive before and/or after allogeneic HSCT. The study protocol entitled "A Phase II Study of Blincyto (Blinatumomab) in Children with CD19+ B-lineage Acute Lymphoblastic Leukemia (ALL) and Minimal Residual Disease (MRD)-Positivity before or following first Allogeneic Hematopoetic Stem Cell Transplantation (HSCT) in complete remission (CR1, CR2, CR3)" was included in the ALL SCTped 2012 FORUM Protocol Appendix 1b. According to protocol, 15 mcg/m2/day of Blincyto is given in continuous intravenous infusion over a 28-day cycle. Starting day for patients who are MRD-positive before HSCT is between day +60 and day +100 and for patients who become MRD-positive post HSCT it is between day +60 and day +360 post HSCT. Patients are evaluated for response at day +28 (+4 days) (bone marrow morphology and MRD analysis - defined by PCR/FLOW-techniques) after start of Blincyto-treatment at the end of first Blincyto infusion and at regular post-TX-checks (according to FORUM: days +28, +60, +100, +180 and +360 after HSCT). The protocol was approved in 10 countries (Austria, Belgium, Czech Republic, Denmark, France, Italy, Norway, Poland, Slovakia and Spain) participating ALL SCTped 2012 FORUM study. Overall, 3 patients were treated with Blincyto (2 in Oslo and 1 in Copenhagen). However, the Investigator Initiated Research Agreement was terminated by Amgen on 26 April 2022, leading to an early termination of the study, which was approved with the last protocol amendment.

NCT ID: NCT04526288 Terminated - Clinical trials for Acute Myeloid Leukemia

CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with high-grade myeloid cancers with measurable residual disease. Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before donor stem cell transplantation may help kill cancer cells in the body and make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

NCT ID: NCT04044560 Terminated - Clinical trials for Minimal Residual Disease

Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

OZM-097
Start date: September 8, 2020
Phase: Phase 2
Study type: Interventional

This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. MRD testing phase and 2. blinatumomab treatment phase. Participants with B-ALL planning for HSCT meeting other eligibility criteria will be enrolled onto the MRD testing phase, which will involve centralized MRD testing of bone marrow aspirate samples on day +56, +100, +180, +270 following HSCT. Participants with detectable MRD ≥10^-4 leukemic cells/total nucleated cells will enroll onto the treatment phase. Blinatumomab treatment will be started following detection of MRD after 7 to 42 days from enrollment onto the treatment phase to allow for initiation of taper of immunosuppressive medications.

NCT ID: NCT03951961 Terminated - Clinical trials for Acute Myeloid Leukemia, Adult

Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation

Start date: March 20, 2020
Phase: Phase 2
Study type: Interventional

The MAURITIUS trial is a single-arm, multicenter phase II study of single treatment with midostaurin being applied to AML (acute myeloid leukemia) patients with activating FLT3 (FMS-like tyrosine kinase3) mutations and either molecular relapse or persistent molecular positivity after allogeneic SCT. The leukemia-free survival (LFS), the achievement of "MRD low" as well as the incidence of GvHD after transplantation reflect the most relevant endpoints of this non-randomized clinical trial.

NCT ID: NCT03549351 Terminated - Clinical trials for Leukemia, Myeloid, Acute

Evaluation of Measurable Residual Disease in Patients With Acute Myeloid Leukemia as Surrogate Endpoint for Survival

PERDAM
Start date: June 1, 2019
Phase:
Study type: Observational

Objectives To demonstrate that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival and thus an early read-out for drug efficacy Study design Surrogate endpoint trial to establish that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival

NCT ID: NCT03441464 Terminated - Prostate Cancer Clinical Trials

Feasibility of the LUM Imaging System for Detection of Prostate Cancer

Start date: March 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015). Patients with an established diagnosis of prostate cancer and who are eligible for radical prostatectomy will be screened. Eligible patients will be enrolled and on the day of their planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients will be monitored for adverse events from time of injection through the first standard of care post-surgical follow-up visit.

NCT ID: NCT03298412 Terminated - Clinical trials for High-risk Diffuse Large B-cell Lymphoma

Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)

Start date: May 23, 2018
Phase: Phase 2
Study type: Interventional

The study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.

NCT ID: NCT03272633 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

Start date: October 26, 2020
Phase: Early Phase 1
Study type: Interventional

This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.

NCT ID: NCT02935543 Terminated - Clinical trials for Leukemia, Acute Lymphoblastic

CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.

NCT ID: NCT02767934 Terminated - Clinical trials for Minimal Residual Disease

Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia

Start date: January 13, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well pembrolizumab works in treating small amounts of cancer cells that remain after attempts to remove the cancer has been made in patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.