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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and understand the side effects of a new treatment for T-cell lymphoma, a type of non-Hodgkin lymphoma. The treatment combines a radioactive antibody, yttrium Y 90 basiliximab, with standard chemotherapy to target and kill cancer cells before a stem cell transplant. This approach may help clear the cancer and prepare the bone marrow for new, healthy cells. The trial is designed for individuals with T-cell lymphoma who have tried other treatments and require a stem cell transplant. Participants should have T-cell lymphoma that has not progressed despite at least two prior therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot receive any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy while participating in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yttrium Y 90 basiliximab, when combined with chemotherapy, is well-tolerated by patients with certain types of lymphoma. In previous studies, most participants found this treatment safe and manageable. However, some serious cases, including deaths, occurred mostly due to disease progression rather than the treatment itself.

Carmustine, a chemotherapy drug used in this trial, has been studied before. Some patients lived longer when it was used, especially alongside other treatments like stem cell transplants.

Etoposide, another chemotherapy drug in this trial, has proven safe. Many patients responded well, with over half achieving a complete response in some studies.

Melphalan is also part of the chemotherapy mix here. It has been used safely in other conditions, and while higher doses can lead to better outcomes, they can also cause more side effects.

Overall, this combination of treatments has been used before and is generally considered safe. However, like all medical treatments, risks and side effects can vary from person to person. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard chemotherapy treatments for T-cell lymphoma, the new approach combines radioimmunotherapy with chemotherapy before a stem cell transplant. This treatment is unique because it uses yttrium Y 90 basiliximab, which delivers targeted radiation directly to lymphoma cells, potentially increasing effectiveness while minimizing damage to healthy cells. Researchers are excited about this combination because it could lead to better outcomes by attacking the cancer more precisely and preparing the body for a more successful stem cell transplant.

What evidence suggests that this trial's treatments could be effective for T-cell lymphoma?

In this trial, participants will receive yttrium Y 90 basiliximab combined with chemotherapy before undergoing a stem cell transplant. Studies have shown that yttrium Y 90 basiliximab, when used with chemotherapy, can directly deliver radiation to cancer cells, aiding in their destruction. Researchers are exploring this method for its potential to improve treatment outcomes for T-cell lymphoma. Etoposide, one of the chemotherapy drugs used in this trial, has been shown to help lymphoma patients live longer without disease progression. Carmustine, another drug in this trial, has helped some patients live longer when used with a stem cell transplant. Melphalan, often administered in high doses, is effective in combination treatments for blood cancers. Together, these treatments aim to destroy cancer cells and prepare the body for new, healthy stem cells. ^{1 2 6 7 8}

Who Is on the Research Team?

Jasmine Zain, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2347966/

Topical carmustine (BCNU) for cutaneous T cell lymphoma The median time to achieve complete response was 11.5 weeks. Favorable results were obtained in patients with less than 5% involvement treated locally. Mild ...

2. sciencedirect.com sciencedirect.com/science/article/pii/019096229070112U

Topical carmustine (BCNU) for cutaneous T cell lymphoma The median time to achieve complete response was 11.5 weeks. Favorable results were obtained in patients with less than 5% involvement treated locally. Mild ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124092735

Outcomes of Secondary CNS Lymphoma with Carmustine ... Our study showed that one third of patients could achieve long term survival with possible cure with aggressive salvage and autologous stem cell transplant.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00961220?term=carmustine&rank=8

O6-Benzylguanine and Topical Carmustine in Treating ... This phase I/II trial studies the side effects and best dose of carmustine when given together with O6-benzylguanine and to see how well they work in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11078515/

Impact of Thiotepa Dose-Intensity in Primary Diffuse Large B ... Thiotepa/carmustine (TT-BCNU) is a commonly used autologous transplant (ASCT) conditioning regimen for primary DLBCL of the CNS (PCNSL).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3519426/

Phase I Clinical Trial of O6-Benzylguanine and Topical ... Phase I clinical trial of O6-Benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, Mycosis fungoides type.

7. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/1377951

Topical Chemotherapy in Cutaneous T-cell Lymphoma ... The use of a novel mechlorethamine, 0.02%, gel in the treatment of patients with mycosis fungoides is effective and safe.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119654030

Safety and Efficacy Of Lomustine (CCNU) Substituting ... We compared the 2 patient groups for engraftment data, treatment related mortality, survival data and the clinical status 1 year post transplant. The status at ...