Tagraxofusp + Chemotherapy for Acute Lymphoblastic Leukemia

Overseen By Nicholas Short

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational agents

Disqualifiers: CNS leukemia, Philadelphia chromosome-positive ALL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

4 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Nicholas Short

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tagraxofusp and Chemotherapy Phase

Patients receive tagraxofusp and chemotherapy drugs in cycles to treat CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.

9 cycles (approximately 8 months)

Multiple visits per cycle for drug administration

Tagraxofusp and Maintenance Phase

Patients receive maintenance therapy with tagraxofusp and other drugs to sustain remission.

15 cycles (approximately 15 months)

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Follow-up at 30 days post-treatment, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Tagraxofusp

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (tagraxofusp, chemotherapy) Experimental Treatment 13 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)

Approved in European Union as Elzonris for:

• Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+