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Neoplasm, Residual clinical trials

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NCT ID: NCT04934930 Recruiting - Follicular Lymphoma Clinical Trials

Adjustment of Chemotherapy Duration in Follicular Lymphoma According to Minimal Residual Disease Status

FLMRD
Start date: January 29, 2020
Phase: Phase 2
Study type: Interventional

Follicular lymphoma (FL) is a chronic indolent malignancy, where treatment with 6 cycles of bendamustine obinutuzumab (BO) is highly effective but at a cost of increased adverse events. Tumor specific DNA can be traced in blood and bone marrow of follicular lymphoma patients even after therapy, and when detected after lymphoma treatment it is referred to as minimal residual disease (MRD). MRD elimination after effective lymphoma treatment is a marker for deep response and correlates with prolonged remission. In this study we aim to omit chemotherapy after 4 cycles of treatment in patients achieving MRD elimination after 3 months of therapy, as well as complete metabolic response on positron emission computed tomography (PET-CT), hoping to preserve treatment effectiveness while reducing adverse events.

NCT ID: NCT04920032 Recruiting - Colorectal Cancer Clinical Trials

Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas

Start date: August 26, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.

NCT ID: NCT04758975 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)

VALUABLE
Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label uncontrolled interventional study aimed a determining therapeutic benefits of the addition of ibrutinib to 12 months of venetoclax (single-agent for 6 months then combined with rituximab for additional 6 months) in patients with treatment-naïve CLL based on a MRD-guided approach. Study treatment will be administered according to the following scheme: VENETOCLAX: Cycle 1 Day 1-Cycle 1 Day 28 Ramp-up with weekly dose escalation; Cycles 2-12: 400 mg QD RITUXIMAB: Cycle 7 Day 1 375 mg/m2; Cycles 8-12 Day 1 500 mg/m2 At the end of Cycle 12 the MRD status is checked: 3 consecutive uMRD in PB + 1 uMRD in BM at last assessment treatment discontinuation and follow-up At least 1 MRD+ sample in the last 3 assessments. Venetoclax 400 mg QD until uMRD or up to 24 months or unacceptable toxicity (whichever occurs first) in combination with IBRUTINIB 420 mg QD until uMRD or PD or unacceptable toxicity. Venetoclax will be administered orally once daily (QD) beginning with a dose-titration phase (Ramp-up Period). At Cycle 7 Day 1 rituximab will be added for up to 6 monthly cycles (Cycle 7 Day 1 rituximab 375 mg/m2, Cycles 8-12 Day 1 rituximab 500 mg/m2). At Cycle 12 Day 1, disease status, renal function and risk of bleeding will be assessed. Minimal residual disease (MRD) will be evaluated serially in both PB and, after 3 consecutive uMRD in PB, in BM. All subjects with uMRD (defined as those with MRD level <10-4 in the PB in 3 consecutive assessments and in a BM aspirate) will discontinue venetoclax at the end of Cycle 12 (i.e. Cycle 12 Day 28). All subjects with detectable MRD (defined as those with MRD level in the PB and/or BM >10-4) and patients with stable disease without any contraindications to ibrutinib will start treatment with ibrutinib. Ibrutinib will be administered at the standard dose in CLL (i.e. 420 mg QD). Venetoclax will be administered until confirmed uMRD (3 consecutive uMRD in PB, the last one with concomitant uMRD in BM), unacceptable toxicity or disease progression or for a maximum of 2 years and ibrutinib will be continued until unacceptable toxicity, confirmed uMRD or disease progression.

NCT ID: NCT04742634 Recruiting - Clinical trials for Myelodysplastic Syndromes

Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant

Start date: May 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators hypothesize that early measurable residual disease (MRD)-guided pre-emptive therapy with decitabine + cedazaridine (DEC-C) will decrease the risk of progression in post-transplant myelodysplastic syndromes (MDS) patients with persistent mutations (molecular MRD). To detect molecular MRD, the investigators will perform ultra-deep, error-corrected panel-based sequencing (MyeloSeq-HD) at Day 30 in post-transplant MDS patients. The investigators will treat patients with detectable molecular MRD with DEC-C to determine if pre-emptive, MRD-guided therapy with DEC-C decreases relapse rates and improves progression-free survival.

NCT ID: NCT04739072 Recruiting - Clinical trials for Colorectal Adenocarcinoma

Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study

Start date: November 22, 2019
Phase:
Study type: Observational

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

NCT ID: NCT04679285 Recruiting - Clinical trials for Acute Myeloid Leukemia

Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

FERTILAM
Start date: April 26, 2021
Phase:
Study type: Observational

Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation. This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

NCT ID: NCT04623216 Recruiting - Clinical trials for Acute Myeloid Leukemia

Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to test the hypothesis that preemptive treatment with sabatolimab, alone or in combination with azacitidine, when administered to participants with AML/secondary AML who are in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (MRD+ post-aHSCT), can enhance the graft versus leukemia (GvL) response and prevent or delay hematologic relapse without an unacceptable level of treatment-emergent toxicities, including clinically significant acute and/or chronic graft-versus-host disease (GvHD) and immune-related adverse events

NCT ID: NCT04604691 Recruiting - Clinical trials for Minimal Residual Disease

Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD)

Start date: February 18, 2022
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.

NCT ID: NCT04541277 Recruiting - Clinical trials for Acute Myeloid Leukemia, Elderly, Unfit

Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy

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

This phase II trial studies how well tislelizumab combined with DNA hypomethylation agent +/- CAG regimen (cytarabine, idarubicin / Aclarithromycin, rhG-CSF/ PEG-rhG-CSF) work in treating patients with high-risk acute myeloid leukemia (AML) or AML patients older than 60 years of age who are unfit for standard-dose chemotherapy. The expressions of PD-1 and PD-L1 are increased in AML cells. However, blocking the immune checkpoint alone has limited efficacy as a single agent in highly proliferative leukemia cells. During the recovery period after cytotoxic chemotherapy, the activation of PD-1/PD-L1 pathway may be increased and DNA hypomethylation agents can also up-regulate PD-1, PD-L1 and PD-L2 in AML patients. The up-regulation and activation of above immune checkpoint molecules are related to chemotherapy resistance. Therefore, adding chemotherapy and epigenetic regulation agents to Immune checkpoint blockade therapy may work better through overcoming drug resistance in AML treatment.

NCT ID: NCT04523857 Recruiting - Breast Cancer Clinical Trials

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

ABBY
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA