Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Marginal Zone Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Complement System Proteins

Antineoplastic Agents, Immunological

Immunologic Factors

10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months

intralesional rituximab

patients in PD or SD during or after administration of 6 doses monthly rituximab will be administered the same dose of intralesional rituximab supplemented by autologous serum

supplemental autologous serum

Andrés JM Ferreri, MD

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.

Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone

assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment

assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response

Andres J. M. Ferreri

Antibodies

Antibodies, Monoclonal

Obinutuzumab

Immunoglobulins

Rituximab 375 mg/m² IV weekly for 4 weeks.

Rituximab 375 mg/m² IV x 4 weekly doses.

Arm A: Rituximab

GA101 1,000 mg (flat dose) IV x 4 weekly doses.

Arm B: GA101

Stephen Ansell, MD

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.

Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.

GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab.

PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab)

Approximately twenty-five patients randomized to GA101 may participate in the sub-study. Electrocardiograms and blood samples will be obtained.

According to the American Cancer Society, it is estimated that approximately 70,800 individuals will be diagnosed with non-Hodgkin's lymphoma (NHL) and over 18,990 men and women will die of the disease in 2014. The survival rates for patients with indolent NHL remained unchanged from the 1950s through the early 1990s, but recent evidence suggests that outcomes are improving. Indolent NHL is a particular challenge because it is an incurable disease requiring multiple treatments; yet relatively long survivals elevate the importance of quality of life associated with treatment.

Agents such as rituximab are active in patients with a low burden of disease and result in high response rates and durable remissions for most patients. However, the optimal therapeutic approach to patients with low-grade lymphoma with a low disease burden is controversial as conventional chemotherapy also results in high rates of response. Regardless of whether patients receive immunotherapy, chemotherapy, or a combination thereof, they unfortunately exhibit a continuing pattern of disease relapse and the median survival for newly diagnosed patients is between 7-10 years.

Rituximab and GA101 both target the CD20 antigen. The CD20 antigen is located on the surface of normal and malignant B-cell lymphocytes. An attractive feature of this target is that CD20 is not on hematopoietic stem cells, nor is it expressed in any great extent on other normal body tissues.

Studies in vitro have shown that rituximab predominantly induces antibody dependent cellular cytotoxicity (ADCC), but also binds complement and directly induces apoptosis in lymphoma cells.

GA101 shows increased ADCC related to an improved binding of the GA101 to the different allotypes expressed by natural killer cells and monocytes. It also has increased direct cell-death related to an elbow hinge amino acid exchange and Type II binding of the CD20 epitope. The safety of GA101 in NHL so far appears to be similar to that observed with rituximab in patients with NHL, except for a higher incidence of infusion-related reactions.

Depletion of malignant B-cells using anti-CD20 monoclonal antibodies has an acceptable safety profile, particularly in patients with low-grade B-cell lymphomas with a low disease burden. To determine whether treatment with GA101 results in better outcomes than that seen with rituximab and to determine which anti-CD20 antibody to utilize in future studies, we will conduct a randomized Phase II trial of rituximab and GA101 in patients with previously untreated low-grade lymphoma. Patients will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging. The endpoints of the study will be the Complete Response (CR), Overall Response Rate (ORR), time to next treatment, progression free survival (PFS), and safety of each treatment arm.

PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab)

Patients randomized to GA101 and who consent to the sub-study will have electrocardiograms obtained pre and post Week 1 and Week 4 to investigate the effect of GA101 on QTc interval. Pharmacokinetic blood samples will also be done to evaluate serum concentrations of GA101 at the same time-points.

Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab)

Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a \>50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion \>1.5cm in any axis or ≥50% increase in previously involved sites.

PET response rate \[PET-documented CR + Partial Response (PR)\] based on PET scan results. Patients with unevaluable disease were included in the denominator.

Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.

CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm.

Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment.

Genentech, Inc.

PrECOG, LLC.

Adverse events were assessed weekly, prior to and during administration of study drug.

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

PS 0

PS 1

The ECOG performance status (PS) measures how a disease impacts a patient's daily living abilities. It describes a patient's level of functioning in terms of their ability to care for themselves, daily \& physical abilities. The PS score ranges from 0 to 5. A PS score of 0 indicates that a patient is fully active \& able to carry out all pre-disease performance without restriction; 1 indicates that a patient is restricted in performance; 2 indicates ambulatory; \& at the extreme, 5 indicates a patient is deceased. High score indicates the disease has a higher negative impact on living abilities.

ECOG Performance Status

Stage III (1)

Stage III (2)

Stage IV

The Ann Arbor staging is used to describe the extent of non-Hodgkin lymphoma (NHL) in adults. There are 4 levels of the Ann Arbor staging system. Stage I means the lymphoma is only in 1 lymph node area or lymphoid organ; II indicates 2 or more groups of lymph nodes on the same side of the diaphragm; III indicates disease is present in lymph node areas on both sides of the diaphragm and may have spread to other organs; and IV shows that disease has spread outside the lymph system and also to the bone marrow, liver, brain, spinal cord or lungs. Higher grades are considered as worse.

Modified Ann Arbor Staging

Grade 1 Follicular NHL

Grade 2 Follicular NHL

Other

Primary Tumor Type

The study closed early due to slow accrual.

PrECOG Statistician

All participants were included in the analysis

Complete Response (CR) Rate

Complete Response

Partial Response

Stable Disease

Progressive Disease

PET Response Rate

Overall Response Rate

Progression Free Survival (PFS)

Overall Study

PRO131921

Bill Ho, M.D.

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.

A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen

Skin and Connective Tissue Diseases

Mastocytosis

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

masitinib (AB1010)

Olivier Lortholary, MD, PhD

This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.

Efficacy will be assessed based on:

Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression

Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Phase IIa, Open-label, Randomized Study of Oral AB1010 in Patients With Systemic Indolent Mastocytosis With Handicap and Not Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)

AB Science

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Daratumumab

Evaluation of NKTR-255 as:

* Monotherapy
* In combination with daratumumab
* In combination with rituximab

This phase will help to determine the RP2D of NKTR-255

Evaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T

Evaluation of RP2D of NKTR-255 as monotherapy and in combination with SC daratumumab in patients with R/R MM

Evaluation of RP2D of NKTR-255 as monotherapy and in combination with rituximab in patients with R/R iNHL

NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability

NKTR-255

NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability

NKTR-255 Q21

Rituximab administered intravenously at specified dose on specified days

Daratumumab administered subcutaneously at specified dose on specified days

Study Director

Patients will receive intravenous (IV) NKTR-255 in 21 or 28 day treatment cycles. During the Part 1 dose escalation portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in Part 2. During the Part 2 dose expansion portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab.

This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.

NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.

This is a Phase 1, open-label, multi-center, dose escalation, dose expansion, safety follow-up, and survival follow-up of NKTR-255 as a single agent and NKTR-255 in combination with DARZALEX FASPRO TM or rituximab. Study treatment is defined as any investigational treatment(s) or marketed product(s), intended to be administered to a study patient according to the study enrollment.

Part 1 will enroll relapsed/refractory multiple myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) patients. In Part 2, Cohort A will enroll NHL patients who have progressed on a chimeric antigen receptor T-cell (CAR-T) product, Cohort B will enroll MM patients who previously received daratumumab and other anti-CD38 therapies to receive NKTR-255 alone and/or in combination with daratumumab, and Cohort C will enroll indolent Non-Hodgkin's Lymphoma (iNHL) patients who previously received rituximab and other therapies to receive NKTR-255 alone and/or in combination with rituximab.

NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

A Phase 1, Open-label, Multi-center, Dose Escalation and Dose Expansion Study of NKTR-255 in Relapsed or Refractory Hematological Malignancies

Safety and tolerability of NKTR-255 as evaluated by incidence of Dose Limiting Toxicities (DLTs), drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5.

Safety and tolerability of NKTR-255 in combination with daratumumab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5

Safety and tolerability of NKTR-255 in combination with rituximab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5

Nektar Therapeutics

Symptoms and General Pathology

Leukemia

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Leukemia, B-Cell

Leukemia, Lymphoid

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Follicular Lymphoma

Analgesics

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Mitoxantrone

Fludarabine

Fludarabine phosphate

Dexamethasone

Dexamethasone acetate

Pixantrone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Pixantrone (BBR 2778)

fludarabine

dexamethasone

rituximab

Scott Stromatt, MD

The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.

The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.

This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.

Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma

A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

CTI BioPharma

Gabriella Camboni, M.D.

The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.

This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment.

Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.

This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:

1. Patients treated with both pixantrone and rituximab, in combination
2. Patients treated with only rituximab

This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.

Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.

Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma

An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)

* objective overall response rate (ORR; CR + PR)
* objective complete response rate (CRR)
* rate of molecular remission
* time to response
* time to complete response
* duration of response
* Time to Tumor Progression requiring treatment
* Quality-Adjusted Time To Progression (QATTP)
* overall survival
* disease-specific survival
* safety/tolerability

Indolent B Cell Lymphoma

Bortezomib

VELCADE and rituximab

The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma	NCT01514344	Ocular Adnexal ...	intralesional r... supplemental au...	18 Years -	IRCCS San Raffaele
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma	NCT01514344	Ocular Adnexal ...	intralesional r... supplemental au...	18 Years -	IRCCS San Raffaele
Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma	NCT01889797	Indolent Non-Ho...	Arm A: Rituxima... Arm B: GA101	18 Years -	PrECOG, LLC.
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma	NCT00452127	Non-Hodgkin's L...	PRO131921	18 Years -	Genentech, Inc.
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis	NCT00831974	Mastocytosis	masitinib (AB10... masitinib (AB10...	18 Years -	AB Science
NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma	NCT04136756	Multiple Myelom... Non-Hodgkin Lym... Indolent Non-Ho...	NKTR-255 NKTR-255 Q21 Rituximab Daratumumab	18 Years - 80 Years	Nektar Therapeutics
Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma	NCT00060684	Lymphoma, Low-G... Lymphoma, Small... Lymphoma, Mixed... Lymphoma, Small...	Pixantrone (BBR... fludarabine dexamethasone rituximab	18 Years -	CTI BioPharma
Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma	NCT00060671	Lymphoma, Folli... Lymphoma, Mixed... Lymphoma, Small... Lymphoma, Low-G...	rituximab Pixantrone (BBR...	18 Years -	CTI BioPharma
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma	NCT00085696	B-Cell Lymphoma Follicular Lymp... Marginal Lympho...	VELCADE and rit...	18 Years -	Millennium Pharmaceuticals, Inc.
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma	NCT00085696	B-Cell Lymphoma Follicular Lymp... Marginal Lympho...	VELCADE and rit...	18 Years -	Millennium Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for indolent

Every month we try and update this database with for indolent cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for indolent

Every month we try and update this database with for indolent cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for indolent cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.