Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT05032183 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-08-11
Summary
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.
Conditions
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent B Acute Lymphoblastic Leukemia
- Recurrent T Acute Lymphoblastic Leukemia
- Refractory B Acute Lymphoblastic Leukemia
- Refractory Lymphoblastic Lymphoma
- Refractory T Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IT
- DRUG
-
Given IV or PO
- BIOLOGICAL
-
Filgrastim-sndz
Given SC
- DRUG
-
Given IV
- DRUG
-
Mercaptopurine
Given PO
- DRUG
-
Mesna
Give IV
- DRUG
-
Methotrexate
Given IT
- BIOLOGICAL
-
Given SC
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Tagraxofusp-erzs
Given IV
- DRUG
-
Vincristine
Given IV
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Nicholas Short, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-17
- Primary Completion
- 2024-07-31
- Completion
- 2024-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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