Acute Myeloid Leukemia (AML)

Researchers are evaluating the side effects and best dose of a radioactive treatment called 211^astatine(At)-BC8-B10 in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. This phase I/II trial studies how this targeted radioactive antibody might help kill cancer cells with less effect on healthy cells before patients undergo a donor stem cell transplant. The study is sponsored by a cancer center and aims to improve treatment outcomes for these serious blood cancers. Participants receive the 211^At-BC8-B10 treatment intravenously over 6 to 8 hours one week before their transplant. Some may also receive 131^I-BC8-B10 and fludarabine phosphate intravenously in the days leading up to transplant. On day 0, patients undergo total-body irradiation and a peripheral blood stem cell transplant. Following transplant, patients take cyclosporine and mycophenolate mofetil orally or intravenously on a schedule that varies depending on their donor type. The study includes possible imaging and sample collections such as SPECT scans, bone marrow aspirates, and blood tests. During the study, participants are closely monitored with various tests and evaluations to track side effects, treatment response, and transplant success. Researchers measure outcomes including serious toxicities within 100 days of transplant, engraftment of donor cells, graft-versus-host disease, remission rates, survival, and relapse over up to two years. Follow-up visits continue at 100 days, 6, 9, 12, 18, and 24 months after treatment to assess long-term effects and health.

Researchers are evaluating the side effects and optimal dose of a radioactive antibody agent called 211At-BC8-B10 in combination with donor stem cell transplant for patients with high-risk acute leukemia or myelodysplastic syndrome that has relapsed or is not responding to treatment. This phase I/II study aims to understand how 211At-BC8-B10, a monoclonal antibody that may affect cancer cell growth, works alongside chemotherapy, total body irradiation, and stem cell transplant to treat these conditions. Participants receive a preparative regimen including an infusion of 211At-BC8-B10 over 6 to 8 hours, followed by fludarabine and cyclophosphamide given intravenously on specific days, and total body irradiation before transplant. On transplant day, patients undergo peripheral blood stem cell or bone marrow transplant. After transplant, patients are given medications cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. They also receive granulocyte colony-stimulating factor until their white blood cell counts recover. During the study, participants have bone marrow biopsies, aspirations, and blood samples collected to monitor their condition. Follow-up visits occur at 100 days, and at 6, 9, 12, 18, and 24 months after treatment. Researchers measure outcomes such as serious toxic side effects, remission rates, engraftment success, donor cell presence, immune recovery, graft versus host disease, survival, and disease-free survival. The study is sponsored by the Fred Hutchinson Cancer Center and includes adults aged 18 to 75 years.

Researchers are evaluating a new combination treatment for patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). This phase I trial studies the safety, side effects, best dose, and potential effectiveness of a radioactive antibody called 225Ac-DOTA-Anti-CD38 daratumumab combined with chemotherapy drugs and targeted radiation as a conditioning treatment before donor stem cell transplant. The treatments aim to prepare the body to accept donor cells and target cancer cells more precisely. Participants receive daratumumab intravenously followed by related radioactive compounds early in the treatment process. They then undergo total marrow and lymphoid irradiation (TMLI) twice daily for several days, combined with chemotherapy drugs fludarabine and melphalan given intravenously. On day 0, patients receive a stem cell transplant, and preventive medications for graft-versus-host disease (GVHD) start before transplant. The study includes detailed imaging scans and biopsies before and during treatment to monitor effects. Throughout the trial, participants have regular evaluations including blood tests, bone marrow biopsies, heart and lung function tests, and various scans. After transplant, they are followed closely with frequent visits for the first 100 days, then less often up to two years to track side effects, transplant success, survival, and disease status. Researchers monitor adverse events, transplant-related complications, and overall outcomes to determine the best dose and safety of this new conditioning approach.

Researchers are studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Researchers are evaluating SCTC21C, a biological treatment, in patients with relapsed or refractory CD38-positive hematologic malignancies. This multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and immune response to SCTC21C. The study includes a dose-finding stage to determine safe dosage levels and a dose-expansion stage to further evaluate selected doses. In the dose-finding stage, participants receive increasing doses of SCTC21C ranging from 0.01 mg up to 960 mg. In the dose-expansion stage, at least 20 participants are randomly assigned in a 1:1 ratio to receive two different doses determined from the earlier stage. SCTC21C is given by subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three to six, and every four weeks thereafter until disease progression or unacceptable side effects occur. Participants will be closely monitored throughout the study with assessments including safety evaluations, adverse event tracking up to 45 days after the last dose, and measuring dose-limiting toxicities during the first 28-day cycle. Researchers will also evaluate tumor response over about one year of treatment. The study expects participants to have regular visits for treatment and monitoring, with the total duration varying depending on individual response and tolerability.

Researchers are investigating the safety and early effectiveness of a special treatment called CLL1 and CD38 dual-target CAR T cell injection for adults with relapsed or refractory acute myeloid leukemia (AML). This phase I, open-label, dose-escalation study focuses on patients whose leukemia has returned or not responded to previous treatments. The trial aims to understand how well this dual-target CAR-T therapy works and its possible risks. The study involves a single treatment arm where participants receive the CAR T cell injection modified to target both CLL1 and CD38 proteins found on leukemia cells. The trial includes two phases: the first uses an accelerated titration design to find a safe dose, and the second follows a 3+3 design to further evaluate dosing. Participants may undergo allogeneic hematopoietic stem cell transplantation after receiving the CAR-T cells if needed. During the study, participants will be closely monitored for dose-limiting toxicities within the first 28 days and tracked for adverse events over 96 weeks. Researchers will assess various outcomes including remission rates, survival, and cell behavior in the body. Participants will undergo regular tests and evaluations according to the study protocol, with follow-up visits scheduled for up to nearly two years after treatment to measure long-term safety and response.

Researchers are studying the safety and effectiveness of CD33 CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (AML). This early phase 1 trial involves a single-arm, open-label, dose-escalation design to evaluate this biological treatment targeting CD33 in patients whose leukemia has returned or not responded to previous treatments. The study aims to better understand how this therapy works in this challenging condition. Participants will receive CD33 CAR T-cells through intravenous infusion. The trial uses a standard 3+3 dose escalation method with three different dose levels to determine the optimal dose. The trial plans to enroll between 15 and 27 participants, all receiving the experimental CAR-T cell treatment during the study period. During the study, participants will be closely monitored for safety by tracking dose-limiting toxicities up to 28 days after treatment and recording any treatment-emergent adverse events for up to two years. Researchers will also assess treatment responses such as complete remission, duration of remission, overall survival, and leukemia-free survival over periods ranging from 12 weeks to two years. Participants can expect regular evaluations including clinical exams, laboratory tests, and follow-up visits throughout the study and beyond to measure these outcomes and ensure safety.

Researchers are studying BP1002, a liposomal Bcl-2 antisense oligodeoxynucleotide, to evaluate its safety, tolerability, and potential effects in patients with refractory or relapsed acute myeloid leukemia (AML). This Phase I/Ib study aims to find dose-limiting toxicities, biologically effective doses, pharmacokinetics, pharmacodynamics, and possible anti-leukemic activity of BP1002 alone and in combination with decitabine. The study is sponsored by Bio-Path Holdings, Inc. The study has two parts: a dose escalation phase where BP1002 is given alone at increasing doses, and a dose expansion phase where BP1002 is combined with decitabine. The dose escalation part evaluates BP1002 monotherapy, while the expansion part assesses the combination treatment. Participants receive the study drugs according to these protocols to determine safety and effective dose recommendations. Participants will undergo regular assessments including blood and bone marrow tests to monitor treatment effects and safety. Researchers will track adverse events, laboratory results, heart rhythms, drug levels in the blood, and immune responses. The study will also evaluate leukemia response indicators and survival outcomes over time. The total participation includes follow-up periods to monitor safety and treatment effects, lasting up to several months.

Researchers are evaluating the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). TQB3455 is an inhibitor targeting the IDH2 enzyme. The study has two stages: the first focuses on safety and tolerability of single or multiple doses in subjects with malignant blood tumors, while the second investigates the efficacy and safety of TQB3455 alone or combined with azacitidine in AML or MDS patients. During stage one, participants take TQB3455 tablets orally once daily for 28 consecutive days per treatment cycle. In stage two, participants receive the same TQB3455 tablet regimen, and some also receive azacitidine injections subcutaneously on days one through seven of each 4-week cycle. Azacitidine is a drug that affects DNA methylation. The study assesses both single and combination treatments through these cycles. Participants will be monitored with multiple assessments including dose-limiting toxicity and maximum tolerated dose during the first 28 days up to 48 weeks. Researchers will also measure overall remission rates, survival, response duration, and complete remission rates up to 48 weeks, along with detailed pharmacokinetic measurements of TQB3455 over multiple time points. Safety and tolerability are closely followed, and patients will be observed up to 96 weeks for overall survival outcomes.

Researchers are evaluating the safety, tolerability, and effectiveness of TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes. This open, multi-center clinical trial is designed as a Phase Ib/II study to better understand how this combination treatment works in these blood cancers. Participants receive TQB3909 tablets once daily in 28-day treatment cycles along with azacitidine. The study focuses on monitoring how well patients tolerate the treatment and its effects on their disease. The trial includes assessment of various response rates and survival outcomes over several weeks. Throughout the trial, participants undergo regular evaluations including monitoring for adverse events and laboratory tests for up to 24 weeks. Researchers measure remission rates, duration of remission, and survival outcomes up to 60 weeks. Participants' safety and response to treatment are closely tracked during the study.