A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
RecruitingThe purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 213 more
SponsorBeOne Medicines
▾Tap for detailsClick for full details — eligibility, all locations, contacts Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
RecruitingThis phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
PhasePhase 3
TypeInterventional
Age365 Days – 25 Years
WhereBirmingham, Alabama, United States + 230 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
RecruitingThis phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 631 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
RecruitingThe goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLaguna Hills, California, United States + 194 more
SponsorBeOne Medicines
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
NCT04811560 ·
Acute Leukemia RecruitingThe purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
PhasePhase 1 / Phase 2
TypeInterventional
Age2 Years
WhereDuarte, California, United States + 101 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
RecruitingThis research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL). It is expected that 40-65 people will take part in this research study. * ABL001 * Dasatinib (Sprycel®) * Prednisone * Blinatumomab
PhasePhase 1
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States + 3 more
SponsorMarlise Luskin, MD
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
NCT04588922 · Hematologic Malignancies
RecruitingSLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WhereBirmingham, Alabama, United States + 31 more
SponsorSellas Life Sciences Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
RecruitingThis is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 61 more
SponsorNurix Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia
RecruitingThis clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML). Newly diagnosed lower-risk JMML patients will receive trametinib and azacitidine. High-risk JMML patients will receive trametinib, azacitidine, fludarabine, and cytarabine.
PhasePhase 1 / Phase 2
TypeInterventional
Age1 Month – 21 Years
WherePhoenix, Arizona, United States + 20 more
SponsorTherapeutic Advances in Childhood Leukemia Consortium
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Olverembatinib (HQP1351) in Patients With CML-CP
NCT06423911 ·
Chronic Myeloid Leukemia, CML, CML, Chronic Phase
RecruitingStudy comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 162 more
SponsorAscentage Pharma Group Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
RecruitingThis is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 15 more
SponsorNurix Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
NCT07294677 ·
Leukemia,
Lymphoma RecruitingThis is a 3-part study to assess the safety of adding capivasertib to a standard of care treatment regimen consisting of venetoclax and low-intensity chemotherapy. This chemotherapy regimen called mini-hyperCVD consists of the chemotherapy drugs, cyclophosphamide, vincristine, dexamethasone; (part A) alternating with high-dose methotrexate and cytarabine (part B) administered approximately every 28 days. In the first part of the study (Cohort 1), the study seeks to determine the recommended dose of capivasertib that can be safely given with venetoclax and chemotherapy. Several doses of capivasertib may be tested in small groups of subjects in this part of the study. The dose tested will be increased or lowered depending on types and frequency of side effects seen until the best, safe dose is found. Once the recommended, safe dose of capivasertib is found, the study will move on to the second part (Cohort 2) and will treat additional participants to learn more about the safety of giving these drugs together. If the combination is determined to be safe overall, the study will move on to the third part (Cohort 3). In this part of the study, participants will be randomized to receive the mini-hyperCVD and venetoclax alone or with capivasertib.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
RecruitingThis phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML. ASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.
PhasePhase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 134 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
RecruitingThis phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.
PhasePhase 3
TypeInterventional
Age1 Year – 25 Years
WhereBirmingham, Alabama, United States + 38 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
RecruitingThis clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 78 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
RecruitingThis screening and multi-sub-study Phase 1b/2/3 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes marker negative sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Patients with myeloid malignancies \[e.g. myelodysplastic syndrome (MDS) or other diseases\], will be allowed to enroll to Master protocol if there is an available sub-study.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 30 more
SponsorBeat AML, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
RecruitingThis study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
Phase—
TypeObservational
Age40 Years – 75 Years
WhereAnchorage, Alaska, United States + 744 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
RecruitingThe purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 113 more
SponsorBeOne Medicines
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
RecruitingThis research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.
PhasePhase 2
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
RecruitingPhase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.
PhasePhase 1 / Phase 2
TypeInterventional
Age30 Days
WhereDuarte, California, United States + 56 more
SponsorSyndax Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts