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

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab

Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.

bendamustine and rituximab

SUMMARY:

This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.

RATIONALE:

Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.

PURPOSE:

This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.

SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Cephalon

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).

Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.

For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.

OBI-888

For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.

This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.

Globo H IHC Assay

Apostolia Tsimberidou, MD, PHD

The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.

OBI Pharma, Inc

Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B

OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 5 mg/kg

OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 10 mg/kg

OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 20 mg/kg

Part B, Cohort Expansion - Cohort 1, Pancreatic

Part B, Cohort Expansion - Cohort 2, Esophageal

Part B, Cohort Expansion - Cohort 3, Gastric

Part B, Cohort Expansion - Cohort 4, Colorectal

Part B, Cohort Expansion - Cohort 5, Basket

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

The safety population consisted of all enrolled subjects who received at least 1 dose of study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)	NCT00076349	Non-Hodgkin's L...	bendamustine an...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.	NCT03573544	Metastatic Soli... Locally Advance...	OBI-888 OBI-888 Globo H IHC Ass...	18 Years -	OBI Pharma, Inc
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.	NCT03573544	Metastatic Soli... Locally Advance...	OBI-888 OBI-888 Globo H IHC Ass...	18 Years -	OBI Pharma, Inc
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)	NCT00076349	Non-Hodgkin's L...	bendamustine an...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for mabs

Every month we try and update this database with for mabs 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 mabs

Every month we try and update this database with for mabs 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 mabs 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.