Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Bortezomib

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

Bendamustine

Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1

Ian W. Flinn, MD, PhD

The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.

Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.

The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in \>1 patient

Millennium Pharmaceuticals, Inc.

Cephalon

SCRI Development Innovations, LLC

Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1

Bendamustine/Bortezomib/Rituximab

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

John D Hainsworth, MD

Complete Response Rate

Overall Response Rate

Median Progression-free Survival

Leukopenia

Neutropenia

Lymphopenia

Thrombocytopenia

Anemia

Peripheral Neuropathy

Diarrhea

Fatigue

Nausea/Vomiting

Cough

Rash

Syncope

Hypocalcemia/Hyponatremia

Number of Participants With Adverse Events as a Measure of Safety.

Combination Therapy

Maintenance Therapy

Symptoms and General Pathology

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

B-cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Peripheral T-cell Lymphoma

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Alemtuzumab

10 mg/day x 5, starting with the first day of chemotherapy

Campath-1H

Issa F. Khouri, MD, BS

High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with the use of Campath-1h, a monoclonal antibody that have a synergistic effect to chemotherapy with minimal toxicity. In addition Campath-1H can improve engraftment of donor cells through its immunosuppressive properties.

Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and lymphoma cells. In addition, it weakens the immune system, helping to prevent the rejection of donor marrow or stem cells.

If you are found to be eligible to take part in this study, you will be admitted to the hospital for treatment. Alemtuzumab will be injected into your vein over a period of 4 hours. This will be done 5 days in a row (Days 1 to 5). Drugs diphenhydramine (Benadryl), solumedrol and acetaminophen (Tylenol) will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab.

You will also receive Carmustine over one hour on the first day. From the second to the fifth day, you will receive cytarabine and etoposide twice a day. On the six day, you will receive melphalan once. Both drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment on this study. Some participants, depending on their type of disease, will also receive rituximab. Rituximab will be given during the first day of chemotherapy then once a week for a total of 4 doses.

When chemotherapy is finished, blood stem cells from a donor will be given through the catheter. G-CSF, a growth factor that promotes the production of blood cells, will be injected under the skin once a day until your blood cell counts recover to a certain level.

Blood tests (about 2 tablespoons each) , urine tests, bone marrow aspirations, and x-rays will be done as needed to track the effects of the transplant. The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days. The CT scans and bone marrow studies will be done at 1, 3, 6, and 12 months and then every 6 months for at least 3 years after transplant. You may also have transfusions of blood and platelets as needed.

You will need to stay in the hospital about 3 to 4 weeks. You will be taken off study if their disease gets worse or intolerable side effects occur. You must stay in the Houston area for about 100 days after the transplant. After that, you will be asked to return to Houston every 6 months for the next 3-5 years for scans (CT, gallium, or PET scans), and bone marrow aspirations over the next 3-5 years.

This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 142 patients will take part in this study. All will be enrolled at M. D. Anderson.

Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

Leudosite

M.D. Anderson Cancer Center

stem cell source

Doug Stewart

Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.

Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.

HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Alberta Health services

Hematologic Neoplasms

Lymphoma, Mantle-Cell

Lymphoma, Large B-Cell, Diffuse

Mantle Cell Lymphoma

Diffuse Large B-Cell Lymphoma

N-(1-(7-fluoro-2-(pyridin-2-yl)quinolin-3-yl)ethyl)-9H-purin-6-amine

Enzyme Inhibitors

Dose selected from Part I dose exploration

The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily.

AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.

AMG 319

This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model \[CRM\] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.

AMG 319 Lymphoid Malignancy FIH

A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies

Amgen

Hodgkin Disease

Hodgkin Lymphoma

Vorinostat

Conatumumab

Histone Deacetylase Inhibitors

AMG 655 (intermediate dose) with Vorinostat

Part 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib

AMG 655 (intermediate dose) with Bortezomib

AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).

AMG 655

Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).

A dipeptide boronic acid analogue with antineoplastic activity.

This is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease.

Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or vorinostat. Subjects will be enrolled into one of two arms based on investigator selection (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm).

Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG 655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in combination with bortezomib will be based on safety and pharmacokinetic information obtained from Part 1 as well as from ongoing AMG 655 trials.

Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat

A Phase 1b Study to Evaluate the Safety and Tolerability of AMG 655 in Combination With Bortezomib or Vorinostat in Subjects With Relapsed or Refractory Lymphoma

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Herbal and Botanical

We will treat 9 patients of each tumor type with a tea made of Graviola Leaves. If no responses are observed then the trial will be closed for that particular histological type. Should a response occur, then the trial will continue to the second stage for that cell type until 24 patients are accrued. If 3 or more responses are observed out of 24 cases, then the result will be considered promising.

Graviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day.

The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment.

Tea Made of Graviola Leaves

Fernando Cabanillas, MD

Idalia Liboy, MD

Mirelis Acosta-Rivera, MD

Margarita Bruno, MD

Luis Cotto, MD

Joel López Figueroa, MD

Fernado Cabanillas, MD

Guanabana, known also as Graviola or Annona muricata is a tropical fruit which has been commonly used as complimentary/alternative medicine in Latin American countries. The main compounds in Graviola are the annonaceous acetogenins. These acetogenins have been shown to be selective and toxic against various types of cancer cells in-vitro and in-vivo experimental animal models. In spite of this evidence of anti tumor activity of Graviola, no prospective clinical studies have been carried out to determine if it also has clinical activity.The Investigator have observed two patients at Auxilio Mutuo Cancer Center who experienced significant tumor shrinkage while taking a tea made of Graviola leaves. Neither of these patients were taking any other treatment for their cancer. The investigator propose to conduct a study using guanabana leaves extract in patients with Gastroesophageal junction(GEJ) adenocarcinoma, as well as in Gastric adenocarcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Low Grade Lymphomas and Colorectal adenocarcinoma.

Patients with relapsed/refractory gastric adenocarcinoma, adenocarcinoma of gastroesophageal junction, hepatocellular carcinoma, colorectal adenocarcinoma will be eligible. Colorectal adenocarcinomas will be eligible after failing second line therapy while the remainder will be eligible after first line therapy depending on the judgment of the treating oncologist. Any patient who refuse to receive chemotherapy will also be eligible even if they have not received chemotherapy. Patients with low grade lymphomas including chronic lymphocytic leukemias whose favorable blood counts and lack of symptoms make the candidates for "watch and wait" approach as well as any patient with low grade lymphoma who because of age or co-morbidity might not be eligible for chemotherapy or who refuse chemotherapy.

Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas

Pilot Phase 2 Study of Graviola (Guanabana) Leaves for The Treatment of Patients With Relapsed or Refractory Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction, Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, Low Grade Lymphomas and Colorectal Adenocarcinoma

RECIST criteria will be used to measure response in solid tumors.

Cheson criteria will be used for lymphomas.

Cases with Chronic Lymphocytic Leukemia will have their Complete Blood Counts monitored and the Absolute lymphocyte count will be followed for response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma	NCT01029730	Lymphoma	Bendamustine Bortezomib Rituximab	18 Years -	SCRI Development Innovations, LLC
Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies	NCT00038883	Leukemia, Lymph... Leukemia, Lymph... Lymphoma, Low-G... Lymphoma, T-Cel... Lymphoma, B-Cel...	Campath-1H	15 Years - 60 Years	M.D. Anderson Cancer Center
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma	NCT00144092	Low Grade Lymph...	stem cell sourc...	18 Years - 65 Years	AHS Cancer Control Alberta
AMG 319 Lymphoid Malignancy FIH	NCT01300026	Cancer Chronic Lymphoc... Diffuse Large C... Hematologic Mal... Hematology Leukemia Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Oncology Oncology Patien... T Cell Lymphoma Tumors	AMG 319	18 Years -	Amgen
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma	NCT00144092	Low Grade Lymph...	stem cell sourc...	18 Years - 65 Years	AHS Cancer Control Alberta
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma	NCT01029730	Lymphoma	Bendamustine Bortezomib Rituximab	18 Years -	SCRI Development Innovations, LLC
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat	NCT00791011	Hodgkin's Lymph... Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Diffuse Large C...	AMG 655 Vorinostat Bortezomib	18 Years -	Amgen
Study of Guanábana Leaves for The Treatment of Patients With Gastric, Gastroesophageal Junction, Pancreatic and Colorectal Adenocarcinomas; Hepatocellular Carcinoma, and Low Grade Lymphomas	NCT04773769	Gastric Adenoca... Adenocarcinoma ... Hepatocellular ... Pancreatic Aden... Low Grade Lymph... Colorectal Aden...	Tea Made of Gra...	18 Years -	Auxilio Mutuo Cancer Center
AMG 319 Lymphoid Malignancy FIH	NCT01300026	Cancer Chronic Lymphoc... Diffuse Large C... Hematologic Mal... Hematology Leukemia Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Oncology Oncology Patien... T Cell Lymphoma Tumors	AMG 319	18 Years -	Amgen
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat	NCT00791011	Hodgkin's Lymph... Low Grade Lymph... Lymphoma Mantle Cell Lym... Non-Hodgkin's L... Diffuse Large C...	AMG 655 Vorinostat Bortezomib	18 Years -	Amgen

Spots Global Cancer Trial Database for low grade lymphoma