24.0515:  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 

Principal Investigator: Mohamed Hegazi, MD 

Phase:  II 

Description:  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.

 ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT06317649?term=NCT06317649&rank=1

24.0501:  A RANDOMIZED PHASE II STUDY COMPARING CYTARABINE + DAUNORUBICIN (7+3) VS (DAUNORUBICIN AND CYTARABINE) LIPOSOME, CYTARABINE + DAUNORUBICIN + VENETOCLAX, ZACITIDINE + 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 

Principal Investigator: Mohamed Hegazi, MD 

Phase:  II 

Description:  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. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05554406?term=NCT05554406&rank=1

24.0491:  MASTER SCREENING AND REASSESSMENT PROTOCOL (MSRP) FOR TIER ADVANCEMENT IN THE NCI MYELOMATCH CLINICAL TRIALS 

Principal Investigator: Mohamed Hegazi, MD 

Phase:  N/A 

Description:  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). 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05564390?term=NCT05564390&rank=1

24.0447:  A Randomized Phase III Study of Neoadjuvant Chemotherapy followed by Surgery versus Surgery Alone for Patients with High-Risk Retroperitoneal Sarcoma (STRASS 2) 

Principal Investigator: Rohit Kumar, MD 

Phase:  III 

Description:  This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT04031677?term=NCT04031677&rank=1

24.0133:  A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCOR FL-2) 

Principal Investigator: John Chao, DO 

Phase:  III 

Description:  Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT05409066?term=NCT05409066&rank=1

23.0879:  A PHASE 1-2 MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF IMPT-314, A CD19-20 BISPECIFIC CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL THERAPY IN PARTICIPANTS WITH RELAPSED OR REFRACTORY AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA.

Principal Investigator: Mohamed Hegazi, MD 

Phase:  I 

Description:  This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL.Up to 30 patients will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose.Phase 2 will enroll 20 additional participants to evaluate further the safety and efficacy of IMPT-314.IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days.Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment. 

More Info:  https://clinicaltrials.gov/study/NCT05826535?term=NCT05826535&rank=1

23.0710:  A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma 

Principal Investigator: Mohamed Hegazi, MD 

Phase:  III 

Description:  This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

More Info:  https://clinicaltrials.gov/study/NCT05675410?term=NCT05675410&rank=1

23.0263: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 inParticipants with Hematologic Malignancies 

Principal Investigator: John Chao, DO 

Phase:  II 

Description:  The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM). 

More Info:  https://clinicaltrials.gov/study/NCT04728893?term=NCT04728893&rank=1

20.0331:  Study Title:  PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMMATIC STUDY) 

Principal Investigator: Mohamed Hegazi, MD 

Phase:  III 

Description:  Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. 

ClinicalTrials.gov:  https://clinicaltrials.gov/study/NCT04071457?term=NCT04071457&rank=1

22.0093: A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia in Adults

Principal Investigator: Mohamed Hegazi, MD

Phase: III

Description: This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

More information: https://clinicaltrials.gov/ct2/show/NCT04530565?term=NCT04530565&draw=2&rank=1

20.0325:  Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator: Ju-Hsein (John) Chao, D.O.

Phase:  III

Description:  This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma. 

More info:  https://clinicaltrials.gov/ct2/show/NCT03937635?term=NCT03937635&draw=2&rank=1

12.0471 - A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients.

Principal Investigator: Mohamed Hegazi, M.D.

Description: This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Phase: II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01656603?term=NCT01656603&rank=1
 

 11.0445 - A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications.

Principal Investigator: Mohamed Hegazi, M.D.

Description: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.  The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Phase: N/A

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01351545?term=NCT01351545&rank=1
 

 08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

03.0165 - NMDP Research Sample Repository for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation.

Principal Investigator: Ju-Hsien (John) Chao, D.O.

Description: This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP).  Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study

 Additional Information: http://clinicaltrials.gov/ct2/show/NCT00495300?term=NCT00495300&rank=1

03.0158 - National Marrow Donor Program Research Database for Hematopoietic Stem Cell Transplantation.

Principal Investigator: Ju-Hsien (John) Chao, D.O.

Description: The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation.   A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01166009?term=NCT01166009&rank=1