IMGN632 for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia+3 MoreIMGN632 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new drug, IMGN632, to see if it is safe and effective in treating patients with blood cancer.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Myeloproliferative Neoplasms
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Up to 24 months

21-day cycle
To assess the rate of composite CR in BPDCN patients
Up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To assess ORR: CR+CRc+CRh+CRi+PR
To assess OS
To assess the duration of CR (DOCR) for patients with CR or CRc
Corticotropin-releasing hormone
To assess the duration of overall response
To assess the percent of BPDCN patients able to bridge to stem cell transplant in the frontline and relapsed/refractory populations separately
To assess the rate of CR+CRc+CRh
To assess transfusion independence
To characterize the PK of IMGN632, total antibody, and FGN849 (the active catabolite)
To evaluate the potential immunogenicity of IMGN632

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Escalation and Expansion
1 of 1

Experimental Treatment

252 Total Participants · 1 Treatment Group

Primary Treatment: IMGN632 · No Placebo Group · Phase 1 & 2

Escalation and Expansion
Drug
Experimental Group · 1 Intervention: IMGN632 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor
29 Previous Clinical Trials
3,748 Total Patients Enrolled
Patrick Zweidler-McKay, MDStudy DirectorImmunoGen, Inc.
2 Previous Clinical Trials
336 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received prior CD123-targeting agents.
Patients with relapsed or refractory BPDCN with 1-3 prior lines of therapy.
Patients with frontline BPDCN who have not received prior systemic therapy.