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A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat

NCT05320380 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-01

No results posted yet for this study

Summary

This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other chemotherapy without causing severe side effects, studies what kind of side effects IMGN632 may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause the leukemia to stop growing or to shrink for a period of time.

Conditions

  • Recurrent Acute Myeloid Leukemia
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Recurrent T Acute Lymphoblastic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory Mixed Phenotype Acute Leukemia
  • Refractory T Acute Lymphoblastic Leukemia

Interventions

DRUG

Anti-CD123 ADC IMGN632

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/biopsy

DRUG

Cytarabine

Given IT and IV

DRUG

Fludarabine Phosphate

Given IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

DRUG

Methotrexate

Given IT

DRUG

Prednisolone

Given IT

Sponsors & Collaborators

  • ImmunoGen, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Matthew A Kutny · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320380 on ClinicalTrials.gov