LEUKEMIA, LYMPHOMA AND MYELOMA (BCT PROGRAM)

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


22.0978:  A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced/Metastatic Solid Tumors

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

More Info:  https://clinicaltrials.gov/ct2/show/NCT05514444?term=NCT05514444&draw=2&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

 

19.0757: A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission

Principal Investigator: Mohamed Hegazi, M.D.

Phase:  III

Description:  This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

More info:  https://clinicaltrials.gov/ct2/show/NCT03267433?term=NCT03267433&draw=2&rank=1

 

19.0403: A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients with Refractory or Relapsed AML

Principal Investigator: Mohamed Hegazi, M.D.

Phase:  I/II

Description: The study is a multicenter, open label Phase I/II trial. Phase 1: To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. Phase 2: To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies.

More info:  https://clinicaltrials.gov/ct2/show/NCT03867682?term=LIN-AC225-AML02&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