Radioimmunotherapy + Chemotherapy Before Stem Cell Transplant for T-Cell Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Investigational agents

Disqualifiers: Progressive disease, Uncontrolled illness, Active infection, others

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

Compensation: Varies

Number of Visits: 31

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a radioactive drug and chemotherapy to treat patients with T-cell non-Hodgkin lymphoma. The treatment aims to kill cancer cells and prepare the body for a stem cell transplant. Radioimmunotherapy has shown good results in earlier studies for non-Hodgkin's lymphoma, even in patients that do not respond to standard chemotherapy.

Research Team

Jasmine Zain, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with mature T-cell non-Hodgkin lymphoma who can undergo high-dose therapy and stem cell transplant. They must have a Karnofsky status of at least 70%, agree to use contraception, have adequate organ function, and collected enough stem cells for the procedure. Excluded are those with prior transplants, uncontrolled illnesses, certain allergies or previous treatments that might interfere.

Inclusion Criteria

Patients with a pathologically confirmed diagnosis of systemic mature T-cell non-Hodgkin lymphoma (NHL) with City of Hope pathology review as per World Health Organization (WHO) classification of lymphomas 2008, who are deemed eligible for high dose therapy and AHCT including patients in:

T-NHL histologies including peripheral T-cell lymphomas (PTCLs), cutaneous T-cell lymphomas (CTCLs) and natural killer (NK)/T cell lymphomas

First remission after initial first-line therapy (CR1) in PTCL patients, except for anaplastic lymphoma receptor tyrosine kinase (ALK)+ anaplastic large cell lymphoma (ALCL) and CTCL; patients with minimal residual disease after induction therapy may also be eligible at the discretion of the principal investigator (PI)

Exclusion Criteria

Prior high dose chemotherapy for autologous hematopoietic cell transplantation or prior allogeneic transplantation

Bone marrow (BM) harvest required to reach adequate cell dose for transplant

Patients should not have any uncontrolled illness including ongoing or active infection requiring therapy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Chemotherapy

Participants receive yttrium Y 90 basiliximab and BEAM chemotherapy as conditioning for autologous hematopoietic cell transplant

3 weeks

Multiple visits for IV administration

Stem Cell Transplant

Participants undergo autologous hematopoietic stem cell transplant

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits at 30, 100, and 180 days, and 1, 1.5, and 2 years

Treatment Details

Interventions

• Autologous Hematopoietic Stem Cell Transplantation
• Basiliximab
• Carmustine
• Etoposide
• Melphalan
• Yttrium Y 90 Basiliximab

Trial Overview The trial tests yttrium Y 90 basiliximab combined with BEAM chemotherapy before autologous hematopoietic stem cell transplantation in treating mature T-cell non-Hodgkin lymphoma. It aims to determine the side effects and best dose of this radioimmunotherapy approach.

Participant Groups

Group I: Treatment (yttrium Y 90 basiliximab, BEAM, AHCT) Experimental Treatment 8 Interventions

Patients receive yttrium Y 90 basiliximab IV on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV BID on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.

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+