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Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia

NCT03441048 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-08

No results posted yet for this study

Summary

This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose, recommended phase 2 dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design with a five-patient cohort at the recommended phase 2 dose.

Conditions

Interventions

BIOLOGICAL

Lintuzumab-Ac-225

Lintuzumab-Ac225 is an immunoconjugate \[antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)\] for the treatment of relapsed/refractory acute myeloid leukemia.

DRUG

Cladribine

Cladribine is a purine antimetabolite.

DRUG

Cytarabine

Cytarabine is an antineoplastic anti-metabolite.

DRUG

Mitoxantrone

Mitoxantrone is an anthracenedione antineoplastic agent.

DRUG

G-CSF

G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Sameem Abedin, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2024-05-22
Completion
2024-05-22
FDA Drug
Yes

Countries

  • United States

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Diseases

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 NCT03441048 on ClinicalTrials.gov