Cladribine for Leukemia, Myelocytic, Acute

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

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.

Eligible Conditions
  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 2 years

1 Year
Progression-free Survival
2 years
Overall survival
28 Days
Maximum-tolerated dose.
The number of subjects with dose-limiting toxicities.
60 days
The number of subjects who have at least one serious adverse event related to the study.
Up to Day 60
The number of subjects experiencing partial remission.
The number of subjects in a morphologic leukemia-free state (MLFS).
The number of subjects with CR with incomplete hematologic recovery (CRi)
The number of subjects with a complete response (CR).

Trial Safety

Trial Design

6 Treatment Groups

Lintuzumab Ac225 (Dose 2 - 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab)
1 of 6
Lintuzumab Ac225 (Dose 3 - 0.75 μCi/kg Ac-225 with 4.7μg/kg lintuzumab)
1 of 6
Lintuzumab Ac225 Recommended Phase 2 Dose (RP2D)
1 of 6
Lintuzumab Ac225 (Dose 1 - 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab)
1 of 6
Lintuzumab Ac225 (Dose 5 - 1.25 μCi/kg Ac-225 with 8.0 μg/kg lintuzumab)
1 of 6
Lintuzumab Ac225 (Dose 4 - 1.00 μCi/kg Ac-225 with 6.4 μg/kg lintuzumab)
1 of 6

Experimental Treatment

26 Total Participants · 6 Treatment Groups

Primary Treatment: Cladribine · No Placebo Group · Phase 1

Lintuzumab Ac225 (Dose 2 - 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab)Experimental Group · 5 Interventions: Lintuzumab-Ac-225 (Dose 2: 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab), Mitoxantrone, Cytarabine, G-CSF, Cladribine · Intervention Types: Biological, Drug, Drug, Drug, Drug
Lintuzumab Ac225 (Dose 3 - 0.75 μCi/kg Ac-225 with 4.7μg/kg lintuzumab)Experimental Group · 5 Interventions: Mitoxantrone, Cytarabine, G-CSF, Cladribine, Lintuzumab-Ac-225 (Dose 3: 0.75 μCi/kg with 4.7μg/kg lintuzumab) · Intervention Types: Drug, Drug, Drug, Drug, Biological
Lintuzumab Ac225 Recommended Phase 2 Dose (RP2D)Experimental Group · 5 Interventions: Lintuzumab-Ac-225 (Recommended Phase 2 Dose), Mitoxantrone, Cytarabine, G-CSF, Cladribine · Intervention Types: Biological, Drug, Drug, Drug, Drug
Lintuzumab Ac225 (Dose 1 - 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab)Experimental Group · 5 Interventions: Lintuzumab-Ac-225 (Dose 1: 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab), Mitoxantrone, Cytarabine, G-CSF, Cladribine · Intervention Types: Biological, Drug, Drug, Drug, Drug
Lintuzumab Ac225 (Dose 5 - 1.25 μCi/kg Ac-225 with 8.0 μg/kg lintuzumab)Experimental Group · 5 Interventions: Mitoxantrone, Lintuzumab-Ac-225 (Dose 5: 1.25 μCi/kg with 8.0 μg/kg lintuzumab), Cytarabine, G-CSF, Cladribine · Intervention Types: Drug, Biological, Drug, Drug, Drug
Lintuzumab Ac225 (Dose 4 - 1.00 μCi/kg Ac-225 with 6.4 μg/kg lintuzumab)Experimental Group · 5 Interventions: Mitoxantrone, Cytarabine, G-CSF, Cladribine, Lintuzumab-Ac-225 (Dose 4: 1.00 μCi/kg with 6.4 μg/kg lintuzumab) · Intervention Types: Drug, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitoxantrone
FDA approved
Cytarabine
FDA approved
Filgrastim
FDA approved
Cladribine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
554 Previous Clinical Trials
1,152,146 Total Patients Enrolled
3 Trials studying Leukemia, Myelocytic, Acute
577 Patients Enrolled for Leukemia, Myelocytic, Acute
Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
70 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a calculated creatinine clearance of 50 mL/min or more.
You have a performance score of 0-2 on the ECOG performance score.
ALT and AST ≤ 5 x ULN.
Female patients must agree to avoid becoming pregnant, and male patients should avoid impregnating a female partner.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.