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Chemotherapy

Lintuzumab-Ac225 + CLAG-M for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Sameem Abedin, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than 25% of blasts must be CD33 positive on flow cytometry using Phycoerythrin (PE) labeled anti-CD33 antibody

Age ≥18 years at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what dose is safe and effective. It enrolls patients who have relapsed or are resistant to other treatments.

Who is the study for?

Adults over 18 with relapsed/refractory acute myeloid leukemia can join this trial. They must have a certain level of heart function, not be pregnant or planning to become so, and their cancer cells need to show a specific marker (CD33). Participants should have acceptable liver and kidney function and cannot have had recent chemotherapy or active malignancies besides some exceptions.Check my eligibility

What is being tested?

The study is testing different doses of Lintuzumab-Ac225 combined with CLAG-M chemotherapy to find the safest and most effective dose for treating acute myeloid leukemia that has come back or didn't respond to previous treatments. It's organized in phases, starting with small groups and expanding once safety is confirmed.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, liver enzyme elevations indicating potential liver damage, and possible heart-related issues due to the stress from treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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More than 25% of my cancer cells test positive for CD33.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

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I have been diagnosed with AML, including types that developed from other conditions.

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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum-tolerated dose.

Overall survival

The number of subjects who have at least one serious adverse event related to the study.

+1 more

Secondary outcome measures

Progression-free Survival

The number of subjects experiencing partial remission.

The number of subjects in a morphologic leukemia-free state (MLFS).

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Lintuzumab Ac225 Recommended Phase 2 Dose (RP2D)Experimental Treatment5 Interventions

The maximum-tolerated dose for lintuzumab-Ac225 is defined as the highest level at which no more than one patient experiences a dose-limiting toxicity. The RP2D is defined as the dose level below the dose where two or more dose-limiting toxicities were observed. CLAG-M chemotherapy will be administered at a fixed dose and schedule (cladribine 5mg/m^2/day IV over two hours on days 2-6; cytarabine 2 gm/m^2/day IV over four hours on days 2-6, starting two hours after the cladribine infusion is complete; mitoxantrone 10mg/m^2/day IV on days 2-4 and G-CSF at a dose of 300 µg on days 1-6). Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.

Group II: Lintuzumab Ac225 (Dose 5 - 1.25 μCi/kg Ac-225 with 8.0 μg/kg lintuzumab)Experimental Treatment5 Interventions

Dose escalation for lintuzumab-Ac225 will be conducted according to a 3+3 design. CLAG-M chemotherapy will be administered at a fixed dose and schedule (cladribine 5mg/m^2/day IV over two hours on days 2-6; cytarabine 2 gm/m^2/day IV over four hours on days 2-6, starting two hours after the cladribine infusion is complete; mitoxantrone 10mg/m^2/day IV on days 2-4 and G-CSF at a dose of 300 µg on days 1-6). Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.

Group III: Lintuzumab Ac225 (Dose 4 - 1.00 μCi/kg Ac-225 with 6.4 μg/kg lintuzumab)Experimental Treatment5 Interventions

Group IV: Lintuzumab Ac225 (Dose 3 - 0.75 μCi/kg Ac-225 with 4.7μg/kg lintuzumab)Experimental Treatment5 Interventions

Group V: Lintuzumab Ac225 (Dose 2 - 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab)Experimental Treatment5 Interventions

Group VI: Lintuzumab Ac225 (Dose 1 - 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab)Experimental Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitoxantrone

2008

Completed Phase 3

~1510

Cytarabine

2016

Completed Phase 3

~3310

G-CSF

2014

Completed Phase 4

~1610

Cladribine

2014

Completed Phase 4

~4390

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,557 Total Patients Enrolled

Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin

4 Previous Clinical Trials

10,086 Total Patients Enrolled

Media Library

Cladribine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03441048 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Lintuzumab Ac225 (Dose 2 - 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab), Lintuzumab Ac225 (Dose 3 - 0.75 μCi/kg Ac-225 with 4.7μg/kg lintuzumab), Lintuzumab Ac225 Recommended Phase 2 Dose (RP2D), Lintuzumab Ac225 (Dose 1 - 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab), Lintuzumab Ac225 (Dose 5 - 1.25 μCi/kg Ac-225 with 8.0 μg/kg lintuzumab), Lintuzumab Ac225 (Dose 4 - 1.00 μCi/kg Ac-225 with 6.4 μg/kg lintuzumab)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining in the research trial?

"This trial is not open for recruitment currently. It was first posted on May 22nd 2018, and the latest update to its status occurred on October 18th 2022. If you're searching for alternative studies, 1535 trials are presently enrolling patients with leukemia or myelocytic acute illnesses while 388 other research projects are actively seeking participants taking Cladribine medication."

Answered by AI

What is the aim of this research endeavor?

"Over the course of two years, this clinical trial will measure its primary outcome: The number of participants who have experienced a serious adverse event in relation to the study. Secondary outcomes include quantifying those in complete remission with incomplete hematologic recovery (CRi), measuring subjects in morphologic leukemia-free state (MLFS) and tabulating patients that achieved partial remissions (PR)."

Answered by AI

What is the cap on participation for this investigation?

"This clinical trial is not presently open for volunteer enrolment. Initially posted on May 22nd 2018, it was last updated October 18th 2022. Currently there are 1535 trials actively seeking patients with leukemia, myelocytic acute and 388 studies recruiting Cladribine participants."

Answered by AI

To what maladies is Cladribine often prescribed?

"Clinicians can prescribe cladribine for bone marrow transplantation, diagnostic imaging, and infection in addition to its traditional use of treating hemopoietic stem cell transplants."

Answered by AI

What other explorations into Cladribine have been conducted in a clinical context?

"At the time of writing this, there are 388 live research projects centered around Cladribine. Out of those trials, 92 have advanced to Phase 3 and 12663 distinct sites are participating in these clinical studies. Most of the research for Cladribine is based out of Saint Louis, Missouri."

Answered by AI