4 Participants Needed

Tagraxofusp + Chemotherapy for Acute Lymphoblastic Leukemia

Nicholas James Short | MD Anderson ...
Overseen ByNicholas Short
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This phase Ib/II trial studies the effects of tagraxofusp and low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp with chemotherapy may help control CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.

Research Team

Nicholas James Short | MD Anderson ...

Nicholas Short

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have taken a pregnancy test within the last week and it was negative.
Serum creatinine =< 1.5 mg/dL
I am willing and able to follow the study's schedule and requirements.
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Exclusion Criteria

I have been diagnosed with Philadelphia chromosome-positive ALL or Burkitt leukemia/lymphoma.
I have lasting side effects from past chemotherapy, but not hair loss, tiredness, or liver issues.
I do not have serious heart problems or uncontrolled high blood pressure.
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Treatment Details

Interventions

  • Dexamethasone
  • Tagraxofusp
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (tagraxofusp, chemotherapy)Experimental Treatment13 Interventions
See Detailed Description

Tagraxofusp is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Elzonris for:
  • Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
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Approved in European Union as Elzonris for:
  • Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+