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New treatment option for Recurrent Adult T-Cell Leukemia/Lymphoma
Official title Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma
ClinicalTrials.gov ID: NCT04848064
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent adult t-cell leukemia/lymphoma.
Also referred to as (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to understand and voluntarily sign an informed consent form
- Age \>= 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy
- Note: extracorporeal photopheresis will be considered a systemic therapy for this study
You likely can't join if
- Investigational therapies in the 2 weeks prior to beginning treatment on trial
- Patients with active central nervous system (CNS) involvement with lymphoma
- Patients with known human immunodeficiency virus (HIV) infection with CD4 \< 350
- Patients who had solid organ transplants
- Evidence of active hepatitis B infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction...
- Present or history of progressive multifocal leukoencephalopathy (PML)
See the full eligibility criteria
- Able to understand and voluntarily sign an informed consent form
- Age \>= 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy
- Note: extracorporeal photopheresis will be considered a systemic therapy for this study
- Patients with large cell transformation of cutaneous T cell lymphoma are eligible
- Patients with adult T-cell leukemia/lymphoma (ATLL) of any stage and any subtypes. Patient must have had at least one standard chemotherapy and measurable disease at the time of enrollment
- Patients who relapsed after autologous or allogeneic stem cell transplant are eligible
- All cancer therapy, including radiation, topical steroid, and chemotherapy must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study. The only exceptions are...
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 at study entry
- Absolute neutrophil count \>= 1000/mm\^3
- Platelet count \>= 50,000/mm\^3
- Total bilirubin =\< 2 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and Alanine Aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =\< 3 x ULN
- AST (SGOT) and ALT (SGPT) =\< 5 x ULN in patients with documented hepatic involvement by lymphoma
- Calculated creatinine clearance \>= 50 ml/min (by the Crockroft-Gault equation)
- Disease free of prior malignancies for \>= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. Patients with early stage of prostate...
- Negative serum pregnancy test at the time of enrollment for females of childbearing potential. Women who can get pregnant and men with partners who can become pregnant will be asked to practice a highly effective method...
- Life expectancy \>= 90 days
- Investigational therapies in the 2 weeks prior to beginning treatment on trial
- Patients with active central nervous system (CNS) involvement with lymphoma
- Patients with known human immunodeficiency virus (HIV) infection with CD4 \< 350
- Patients who had solid organ transplants
- Evidence of active hepatitis B infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active hepatitis C infection based on positive PCR. Patients who...
- Present or history of progressive multifocal leukoencephalopathy (PML)
- Active grade II-IV acute or extensive chronic graft versus (vs.) host disease (GVHD)
- Patients may take steroids at any dose for disease control up to 24 hours prior to study enrollment. Steroids must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in...
- Any illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
- A cardiovascular disability status of New York Heart Association class \>= 2
- History of severe allergic reactions to humanized monoclonal antibodies
- History of other malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma or Stage 1 melanoma of the skin or...
- Known hypersensitivity to any of the study drugs or analogs
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV...
- Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
- Recent major surgery (within 6 weeks prior to the start of study treatment) other than for diagnosis
- Receiving immunosuppressive therapy
- Prior therapy with mogamulizumab unless stopped previously for reasons other than progression or toxicity.
- Pregnant or lactating, or intending to become pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.