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Title: Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy
Brief Title: A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Brief Summary: The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine
(AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants
with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A
gene.
For info regarding 25-649
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1, First in Human Study of adoptive T cell therapy with T cells stimulated by
dendritic cell (DC)/tumor fusions in combination with decitabine and venetoclax in patients with acute myeloid leukemia (AML)
Brief Title: Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
Brief Summary: The goal of this research study is to test if the combination of a new T cell therapy
(dendritic cell (DC) / acute myeloid leukemia (AML) primed T cells), vaccine (DC/AML
fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and
effective for treatment of acute myeloid leukemia (AML).
The names of the study drugs involved in this study are:
- DC/AML fusion vaccine (immune cell vaccine)
- Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor
or hormone)
- DC/AML Primed T cells (immune cells)
- Decitabine (a type of chemotherapy drug)
- Venetoclax (a type of antineoplastic agent)
For info regarding 25-593
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 2, Randomized, Open-label, Study of Momelotinib in Participants with Anemia due to Low-risk Myelodysplastic Syndrome
Brief Title: A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Brief Summary: The goal of this clinical trial is to determine if momelotinib is safe and effective for
people with low-risk myelodysplastic syndromes (LR-MDS). The trial will also examine how
the body processes the drug. Participants will receive different doses of momelotinib to
find the best dose by evaluating effectiveness in improving red blood cell transfusion
requirements and safety.
For info regarding 25-591
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
Brief Title: Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Brief Summary: The safety, tolerability, and antileukemic response of ziftomenib in combination with
standard of care treatments for patients with relapsed/refractory acute myeloid leukemia
will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and
gilteritinib.
For info regarding 25-470
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: MM1OA-EA02, A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
Brief Title: Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Brief Summary: This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and
venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in
treating older and unfit patients with acute myeloid leukemia and FLT3 mutations.
Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer
suppressor genes, which are genes that help control cell growth. 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. Gilteritinib
is in a class of medications called kinase inhibitors. It works by blocking the action of
a certain naturally occurring substance that may be needed to help cancer cells multiply.
This study may help doctors find out if these different approaches are better than the
usual approaches. To decide if they are better, the study doctors are looking to see if
the study drugs lead to a higher percentage of patients achieving a deeper remission
compared to the usual approach.
For info regarding 25-152
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by myeloMATCH; A myeloMATCH Clinical Trial
Brief Title: Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Brief Summary: This phase II MyeloMATCH treatment trial tests whether the standard approach of
cytarabine and daunorubicin in comparison to the following experimental regimens works to
shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin
and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3)
azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax.
"High-risk" refers to traits that have been known to make the AML harder to treat.
Cytarabine is in a class of medications called antimetabolites. It works by slowing or
stopping the growth of cancer cells in the body. Daunorubicin is in a class of
medications called anthracyclines. It also works by slowing or stopping the growth of
cancer cells in the body. Azacitidine is in a class of medications called demethylation
agents. It works by helping the bone marrow to produce normal blood cells and by killing
abnormal cells. 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. There is evidence that these newer experimental treatment
regimens may work better in getting rid of more AML compared to the standard approach of
cytarabine and daunorubicin.
For info regarding 25-077
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: MYELOMATCH, MASTER SCREENING AND REASSESSMENT PROTOCOL FOR TIER ADVANCEMENT IN THE NCI MYELOMATCH CLINICAL TRIALS
Brief Title: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Brief Summary: This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a
screening tool and specific laboratory tests to help improve participants' ability to
register to clinical trials throughout the course of their myeloid cancer (acute myeloid
leukemia or myelodysplastic syndrome) treatment. This study involves testing patients'
bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is
any molecule in the body that can be measured. Doctors look at markers to learn what is
happening in the body. Knowing about certain markers can give doctors more information
about what is driving the cancer and how to treat it. Testing patients' bone marrow and
blood will show doctors if patients have markers that specific drugs can target. The
marker testing in this study will let doctors know if they can match patients with a
treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer
they have or continue standard of care treatment with their doctor on the Tier
Advancement Pathway (TAP).
For info regarding 24-730
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu
Title: A Phase 1 Study of PF-08046040/SEA-CD70 in Myeloid Malignancies
Brief Title: A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Brief Summary: This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out
if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid
leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it
works for AML and MDS. A side effect is anything the drug does besides treating cancer.
This study will have seven groups or "parts."
- Part A will find out how much SEA-CD70 should be given to participants
- Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it
works to treat participants with MDS.
- Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it
works to treat participants with AML.
- Part D will find out how much SEA-CD70 with azacitidine should be given to
participants
- Part E will use the dose found in Part D to find out how safe SEA-CD70 with
azacitidine is and if it works to treat participants with MDS or MDS/AML that has
not been treated.
- Part F will use the dose found in Part D to find out how safe SEA-CD70 with
azacitidine is and if it works to treat participants with MDS or MDS/AML.
- Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should
be given to participants with AML. Also, to evaluate safety and tolerability of
PF-08046040 in combination with azacitidine and venetoclax in participants with
previously untreated AML who are unfit for standard induction chemotherapy.
For info regarding 20-191
please contact Cancer Clinical Trials at 617-975-7403 or
cancerclinicaltrialsinfo@bidmc.harvard.edu