Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

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

SAR3419

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

Sanofi

Symptoms and General Pathology

Syndrome

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Dendritic Cell Tumor

Blastic Plasmacytoid Dendritic Cell

Dose Escalation: SAR443579 administered intravenously at escalating dose levels.

Dose Expansion: SAR443579 administered intravenously at the recommended dose and schedule determined from the dose escalation.

Powder for solution for infusion; by IV infusion

SAR443579

Trial Transparency email recommended (Toll free for US & Canada)

This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

An Open-label, First-in-human, Dose-escalation/Expansion Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Adult and Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Hematologic Neoplasms

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN.

Expansion: IMGN632 was administered by IV:

* Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN)
* Cohort 2: Relapsed AML
* Cohort 3: Relapsed or refractory ALL
* Cohort 4: Other relapsed or refractory hematologic malignancies
* Cohort 5: Relapsed or refractory AML at alternate dose or schedule
* Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.

IMGN632

Patrick Zweidler-McKay, MD

This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Conversion rate to independence of red blood cell (RBC) and platelet transfusion relative to baseline

ImmunoGen, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SAR3419 in Acute Lymphoblastic Leukemia	NCT01440179	Acute Lymphocyt...	SAR3419	16 Years -	Sanofi
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)	NCT05086315	Acute Lymphocyt... Acute Myeloid L... Myelodysplastic... Blastic Plasmac...	SAR443579	1 Year -	Sanofi
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN	NCT03386513	Blastic Plasmac... Myeloproliferat...	IMGN632	18 Years -	ImmunoGen, Inc.

Spots Global Cancer Trial Database for acute lymphocytic leukaemia