Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Lymphoproliferative Disorders

Lymphoma, B-Cell

Hematologic Diseases

Immunoproliferative Disorders

Lymphatic Diseases

Neoplasms by Histologic Type

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Dacetuzumab

Antineoplastic Agents, Immunological

1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.

SGN-40

Nancy Whiting, PharmD

This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.

Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Genentech, Inc.

Seagen Inc.

Antirheumatic Agents

Gemcitabine

Rituximab

Immunologic Factors

Antimetabolites

4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.

375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.

rituximab

1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.

gemcitabine

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.

SGN-40 (anti-huCD40 mAb)

Jonathan Drachman, MD

This is an open-label, dose-escalation study to determine the tolerability, safety profile, and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose escalation during the first two weeks regardless of cohort designation.

A minimum of three patients will be entered into each dose-level cohort for five weeks. Escalation to the next cohort will occur when three patients have received at least one infusion at the highest scheduled dose level, and at least one patient has completed the entire five week dosing schedule. Cohorts will be enrolled at a maximal dose level of 3, 4, 6, or 8 mg/kg/week. Initial therapy will last for 5 weeks. Responding patients will receive additional infusions every two weeks x 4 at the maximal dose for each specific cohort.

A Safety Study in Patients With Chronic Lymphocytic Leukemia

A Phase 1/2, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Chronic Lymphocytic Leukemia

Jonathan Drachman, Sr. Medical Director

Carboplatin

Etoposide

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

SGN-40, rituximab, etoposide, carboplatin, ifosfamide

placebo, rituximab, etoposide, carboplatin, ifosfamide

2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.

placebo

375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

etoposide

carboplatin

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

ifosfamide

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Heart and Blood Diseases

Vascular Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Paraproteinemias

Hemorrhagic Disorders

Blood Protein Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Coagulants

Dexamethasone

Lenalidomide

Dexamethasone acetate

BB 1101

Hemostatics

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.

lenalidomide

dexamethasone

This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.

Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma	NCT00435916	Lymphoma, Large... Lymphoma, Non-H...	SGN-40	18 Years -	Seagen Inc.
Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL	NCT00655837	Lymphoma, Large... Lymphoma, Non-H...	SGN-40 rituximab gemcitabine	18 Years -	Seagen Inc.
A Safety Study in Patients With Chronic Lymphocytic Leukemia	NCT00283101	Leukemia, Lymph...	SGN-40 (anti-hu...	18 Years -	Seagen Inc.
A Safety Study in Patients With Chronic Lymphocytic Leukemia	NCT00283101	Leukemia, Lymph...	SGN-40 (anti-hu...	18 Years -	Seagen Inc.
A Safety Study in Patients With Chronic Lymphocytic Leukemia	NCT00283101	Leukemia, Lymph...	SGN-40 (anti-hu...	18 Years -	Seagen Inc.
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma	NCT00435916	Lymphoma, Large... Lymphoma, Non-H...	SGN-40	18 Years -	Seagen Inc.
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL	NCT00529503	Lymphoma, Large... Lymphoma, Non-H...	SGN-40 placebo rituximab etoposide carboplatin ifosfamide	18 Years - 75 Years	Seagen Inc.
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma	NCT00525447	Multiple Myelom...	SGN-40 lenalidomide dexamethasone	18 Years -	Seagen Inc.
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL	NCT00529503	Lymphoma, Large... Lymphoma, Non-H...	SGN-40 placebo rituximab etoposide carboplatin ifosfamide	18 Years - 75 Years	Seagen Inc.

Spots Global Cancer Trial Database for antigens, cd40