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Immunotoxin

Tagraxofusp + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1 & 2
Waitlist Available
Led By Nicholas Short
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For females of childbearing potential, a negative pregnancy test must be documented within 1 week of starting treatment
Serum albumin >= 3.2 g/dL (32 g/L). Albumin infusions are not permitted in order to enable eligibility
Must not have
Diagnosis of Philadelphia chromosome-positive ALL or Burkitt leukemia/lymphoma
Persistent clinically significant toxicities grade >= 2 from previous chemotherapy (excluding alopecia, nausea, fatigue, and liver function tests [as mandated in the inclusion criteria])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the effects of tagraxofusp combined with low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back or does not respond to treatment.

Who is the study for?
Adults aged 18-70 with CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma can join. They must have certain normal blood test results, no serious heart, liver, lung diseases, HIV, hepatitis B/C and agree to use effective birth control. Pregnant women and those with other life-threatening cancers cannot participate.
What is being tested?
The trial is testing tagraxofusp combined with low-intensity chemotherapy in patients whose leukemia or lymphoma has returned after treatment or hasn't responded to previous treatments. Tagraxofusp targets cancer cells by linking a toxin to IL3 which is present on the cells' surface.
What are the potential side effects?
Possible side effects include reactions at the infusion site, general weakness, nausea, potential organ inflammation due to the targeted toxin in tagraxofusp as well as typical chemotherapy-related side effects like hair loss and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have taken a pregnancy test within the last week and it was negative.
Select...
My blood protein level is at least 3.2 g/dL without infusions.
Select...
I am 18-70 years old with a specific type of leukemia or lymphoma that tests positive for CD123.
Select...
I will use effective birth control during and for 4 months after the study.
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I can do most of my daily activities on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Philadelphia chromosome-positive ALL or Burkitt leukemia/lymphoma.
Select...
I have lasting side effects from past chemotherapy, but not hair loss, tiredness, or liver issues.
Select...
I do not have serious heart problems or uncontrolled high blood pressure.
Select...
I have active leukemia in my brain or spinal cord.
Select...
I am currently experiencing symptoms of graft versus host disease.
Select...
I have a serious infection that isn't getting better with antibiotics.
Select...
I have hepatitis B, C, or HIV.
Select...
My heart's pumping ability is below the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate
Secondary study objectives
Complete response
Overall survival
Relapsed-free survival (RFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tagraxofusp, chemotherapy)Experimental Treatment13 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Leucovorin
2005
Completed Phase 4
~6010
Methotrexate
2019
Completed Phase 4
~4400
Mesna
2003
Completed Phase 2
~1380
Prednisone
2014
Completed Phase 4
~2500
Vincristine
2003
Completed Phase 4
~2970
Cyclophosphamide
2010
Completed Phase 4
~2310
Cytarabine
2016
Completed Phase 3
~3330
Pegfilgrastim
2013
Completed Phase 3
~4440
Mercaptopurine
2012
Completed Phase 4
~12550
Filgrastim-sndz
2017
Completed Phase 2
~100
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,823 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
188 Total Patients Enrolled
Nicholas Short, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
354 Total Patients Enrolled

Media Library

Tagraxofusp (Immunotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05032183 — Phase 1 & 2
T-Lymphoblastic Lymphoma/Leukemia Research Study Groups: Treatment (tagraxofusp, chemotherapy)
T-Lymphoblastic Lymphoma/Leukemia Clinical Trial 2023: Tagraxofusp Highlights & Side Effects. Trial Name: NCT05032183 — Phase 1 & 2
Tagraxofusp (Immunotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032183 — Phase 1 & 2
~1 spots leftby Jul 2025
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