IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

ImmunoGen

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Lymphoma, Non-Hodgkin

Treatments: Drug: IMGN529

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534715

IMGN0301

Details and patient eligibility

About

The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
• Adequate organ function
• ECOG ≤ 2
• Recovered or stabilized from prior treatments.

Exclusion criteria

• Allogeneic stem cell transplantation
• Pregnant or lactating females
• Known central nervous system, meningeal or epidural disease including brain metastases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

IMGN529

Experimental group

Description:

Dose escalation study, dosing done every 3 weeks.

Treatment:

Drug: IMGN529