Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04871607
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Basiliximab — BIOLOGICAL
    Given IV
  • Carmustine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Genetically Engineered Hematopoietic Stem Progenitor Cells — BIOLOGICAL
    Given via infusion
  • Recombinant Granulocyte Colony-Stimulating Factor — BIOLOGICAL
    Given SC or IV
  • Yttrium Y 90 Basiliximab — BIOLOGICAL
    Given IV

Study Details

This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Key Dates

Start date
Nov 2, 2021
Status verified
Dec 2025
Primary completion
Oct 2, 2029
Completion
Oct 2, 2029

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)
    Patients receive 'cold' basiliximab IV followed by yttrium Y 90 basiliximab IV on day -14. Patients also receive carmustine IV on over 4 hours day -6, etoposide IV over 1 hours QD and cytarabine IV over 2 hours BID or QD on days -5 to -2, and melphalan IV over 1 hours on day -1. Patients then receive HPC-A product via infusion on day 0. Beginning day 5, patients receive G-CSF (or biosimilar) SC or IV until ANC \> 500 for 3 consecutive days or according to the treating physician's best clinical judgement.

Primary Outcome Measure

Progression free survival [ Time Frame: From the start of treatment up to 5 years post transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Alex F. Herrera
[email protected]
626-256-4673
Alex F. Herrera (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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