Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05032183
Phase
PHASE1/PHASE2
Status
Terminated

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT
  • Dexamethasone — DRUG
    Given IV or PO
  • Filgrastim-sndz — BIOLOGICAL
    Given SC
  • Leucovorin — DRUG
    Given IV
  • Mercaptopurine — DRUG
    Given PO
  • Mesna — DRUG
    Give IV
  • Methotrexate — DRUG
    Given IT
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Tagraxofusp-erzs — BIOLOGICAL
    Given IV
  • Vincristine — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Feb 17, 2022
Status verified
Jul 2025
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tagraxofusp, chemotherapy)
    See Detailed Description

Primary Outcome Measure

Participants With a Response [ Time Frame: Within 3 cycles of treatment initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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