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

ConditionsRecurrent Hodgkin LymphomaRefractory Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years

Karnofsky performance status ≥ 70%

Life expectancy ≥ 6 months Nature of Illness and Illness Related Criteria

Histologically confirmed HL

Disqualifiers

Planned BV consolidation after AHCT

Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation.

Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the Radiation Oncology PI.

Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Basiliximab

    Biological/Vaccine

    Given IV

  • Carmustine

    Drug

    Given IV

  • Cytarabine

    Drug

    Given IV

  • Etoposide

    Drug

    Given IV

  • Genetically Engineered Hematopoietic Stem Progenitor Cells

    Biological/Vaccine

    Given via infusion

  • Recombinant Granulocyte Colony-Stimulating Factor

    Biological/Vaccine

    Given SC or IV

  • Yttrium Y 90 Basiliximab

    Biological/Vaccine

    Given IV

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Treatment (yttrium Y 90 basiliximab, chemotherapy, HPC-A)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Disease relapse or progression, or death from any cause, whichever occurs first. Will be calculated using the Kaplan-Meier method.

Time frame
From the start of treatment up to 5 years post transplant

Secondary outcomes

1

Overall survival

Death from any cause. Will be calculated using the Kaplan-Meier method.

Time frame
From the start of treatment up to 5 years post transplant
2

Relapse or progression

Relapse or progression of Hodgkin lymphoma.

Time frame
From the start of treatment up to 5 years post transplant
3

Non-relapse mortality

Death from causes other than relapse or progression.

Time frame
From the start of treatment up to 5 years post transplant
4

Incidence of toxicities and adverse events

Toxicity information recorded will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Toxicities will be recorded using both the Bearman criteria and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 scale.

Time frame
Day -14 to day 100 post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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