Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

SAR3419

Bertrand COIFFIER, Professor of Hematology

The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.

Secondary objectives are:

* to characterize the global safety profile
* to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
* to assess preliminary evidence of anti-lymphoma activity.

SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma

A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)

Sanofi

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Antibodies

Immunoglobulins

Maytansine

Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.

Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

Clinical Sciences & Operations

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

* Response duration
* Progression Free Survival
* Minimal residual disease
* Safety
* Pharmacokinetics

The duration of the study for an individual patient will include:

* The screening period = up to 4 weeks prior to the first administration of SAR3419.
* The treatment period:

  * Induction period = 4 to 8 weeks
  * Maintenance = up to a total maintenance treatment of 6 months
  * A safety follow-up period of 42 days after the last dose.
* Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.

SAR3419 in Acute Lymphoblastic Leukemia

Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Lymphoma, Large B-Cell, Diffuse

Diffuse Large B-Cell Lymphoma

Antirheumatic Agents

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Pharmaceutical form:solution for infusion Route of administration: Intravenous

Pharmaceutical form:solution for infusion Route of administration: intravenous

rituximab

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

* Progression Free Survival
* Overall Survival
* Response Duration

* The screening period = up to 4 weeks prior to the first administration of combined therapy
* The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.
* The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.

Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

* Progression Free Survival
* Overall Survival
* Response Duration
* Safety

The screening period = up to 4 weeks prior to SAR3419 administration

The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit.

All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.

SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.

Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma	NCT00796731	Lymphoma Non-Hodgkin	SAR3419	18 Years -	Sanofi
SAR3419 in Acute Lymphoblastic Leukemia	NCT01440179	Acute Lymphocyt...	SAR3419	16 Years -	Sanofi
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma	NCT01470456	Diffuse Large B...	SAR3419 rituximab	18 Years -	Sanofi
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients	NCT01472887	Diffuse Large B...	SAR3419	18 Years -	Sanofi
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma	NCT00549185	Lymphoma Non-Hodgkin	SAR3419	18 Years -	Sanofi
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients	NCT01472887	Diffuse Large B...	SAR3419	18 Years -	Sanofi

Spots Global Cancer Trial Database for sar3419

Every month we try and update this database with for sar3419 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 sar3419

Every month we try and update this database with for sar3419 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 sar3419 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.