Radiolabeled Monoclonal Antibody + Chemotherapy Before Stem Cell Transplant for Hodgkin Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Disqualifiers: Lymphocyte-predominant HL, Prior transplants, Active hepatitis, HIV, Myelodysplasia, others

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

Compensation: Varies

Number of Visits: 90

Duration: 3 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells

Research Team

Eileen Smith

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with Hodgkin lymphoma that didn't respond to initial treatment or came back after therapy. Participants must have acceptable organ function, not be pregnant or breastfeeding, agree to use birth control, and have collected enough stem cells for transplant. They should not have had certain previous treatments like high-dose chemo with stem cell transplant or radiation to critical organs.

Inclusion Criteria

Hodgkin lymphoma that is:

Pathology confirmation of HL with City of Hope (COH) pathology review

PIF (primary induction failure): did not enter complete remission with first line of therapy; Note: a patient with PIF who responds to salvage therapy with a PR or CR is also eligible (and would be considered PIF-sensitive)

Exclusion Criteria

Positive human immunodeficiency virus antibody

Lymphocyte-predominant Hodgkin lymphoma

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry Study

Patients receive basiliximab IV and indium In 111 basiliximab IV on day -21 and undergo imaging scans to determine biodistribution

3 weeks

Daily imaging visits

Treatment

Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14, followed by BEAM chemotherapy and autologous hematopoietic progenitor cell infusion

3 weeks

Multiple in-person visits for infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at day 90-100, 180, 1 year, 1.5 years, and annually up to 5 years

Treatment Details

Interventions

• Basiliximab
• Carmustine
• Cytarabine
• Etoposide
• Melphalan
• Radiolabeled Monoclonal Antibody Therapy
• Yttrium Y 90-labeled basiliximab

Trial Overview The study tests a radiolabeled monoclonal antibody (yttrium Y 90-labeled basiliximab) combined with BEAM chemotherapy before a stem cell transplant in patients whose Hodgkin lymphoma has relapsed or was resistant from the start. The goal is to see how well this approach works and what the best dose of the antibody therapy might be.

Participant Groups

Group I: Treatment (radiolabeled monoclonal antibody, chemotherapy) Experimental Treatment 9 Interventions

DOSIMETRY STUDY: Patients receive basiliximab IV and indium In 111 basiliximab IV on day -21. Patients undergo indium In 111 imaging scans daily. Patients with appropriate biodistribution continue on to treatment. TREATMENT: Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14. Patients also receive BEAM chemotherapy comprising carmustine IV over 2 hours on days -7 and -6, etoposide IV BID over 4 hours and cytarabine IV over 2 hours BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic progenitor cell infusion on day 0.

Carmustine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as BiCNU for:

• Brain tumors
• Multiple myeloma
• Hodgkin's disease
• Non-Hodgkin's lymphoma

Approved in European Union as Carmubris for:

• Brain tumors
• Multiple myeloma
• Hodgkin's disease
• Non-Hodgkin's lymphoma

Approved in Canada as BCNU for:

• Brain tumors
• Multiple myeloma
• Hodgkin's disease
• Non-Hodgkin's lymphoma

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+