Lymphoma, T-Cell, Cutaneous Clinical Trial
Official title:
Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma With Cutaneous Presentation: A Biomarker Phase Ib/IIa Study
Verified date | July 2023 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan to investigate AFM13 and evaluate its ability to facilitate and redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the skin and, by inference, other organs involved by the lymphoma.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Histologically confirmed CD30-positive lymphoma with cutaneous involvement - Failure or intolerance to at least one prior therapy for the current disease - Presence of one or more cutaneous lesions (measuring at least 1 cm x 1 cm in size; if only one lesion is present it should be up to the investigator discretion to determine eligibility) - Eastern Cooperative Oncology Group (ECOG) performance status =2 - Adequate organ and marrow function - Platelets =50,000/µL - Absolute neutrophil count = 1,000/µL - Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvement - Serum albumin = 2.0 g/dL - Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) =2.5 × institutional ULN or, in the case of liver involvement by the primary disease AST/ALT = 5 x ULN - Creatinine=1.5 x institutional ULN or estimated creatinine clearance of =45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance >45 mL/min - Females of child bearing potential must have a negative serum pregnancy test with 7 days prior to first dose of treatment. Female patients of childbearing potential and all male partners must agree to use double barrier methods of contraception throughout the study period and for at least 30 days following investigational product discontinuation. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Any cancer-related therapy for the current disease within 2 weeks of screening (all supportive care measures are allowed) - Major surgery within 2 weeks prior to first dose of study drug - Evidence of active central nervous system (CNS) involvement - Requirement for systemic immunosuppressive therapy (e.g. Graft-versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of study drug) - Uncontrolled concurrent serious illness. - Concurrent malignancy or history of a previous malignancy within 3 years prior to first dose of the current study, unless curatively resected basal, squamous cell carcinoma of the skin, or cervical carcinoma in situ. - Active infections including hepatitis B carrier status, hepatitis C virus (HCV) infection (patients must have a negative Hepatitis B and Hepatitis C viral load at screening) - Known HIV-positive status - Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as: - unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association (NYHA) III or IV), myocardial infarction = 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents = 6 months before study drug start - severely impaired lung function - Serious, systemic infection requiring treatment =7 days before the first dose of study drug - Any severe, uncontrolled disease or condition which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the study. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Lymphoid Malignancies | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Ahmed Sawas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Incidence of Treatment-Emergent Adverse Events [Safety and Toxicity] broken down by adverse event and CTCAE v4.0 grade of each event. | Up to 2 years | |
Secondary | Overall Response Rate (ORR) | The sum of patients with partial responses and complete responses. | Up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03357224 -
PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL)
|
Phase 2 | |
Completed |
NCT02567656 -
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
|
Phase 1 | |
Completed |
NCT00051012 -
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
|
Phase 4 | |
Recruiting |
NCT03646422 -
AEDV Registry of Primary Cutaneous Lymphoma
|
||
Terminated |
NCT03789864 -
Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
|
N/A | |
Active, not recruiting |
NCT04998331 -
A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
|
||
Active, not recruiting |
NCT02953301 -
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
|
Phase 2 | |
Completed |
NCT01433731 -
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
|
Phase 1 | |
Completed |
NCT01486277 -
A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
|
Phase 2 | |
Completed |
NCT05137847 -
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
|
||
Active, not recruiting |
NCT03902184 -
IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
|
Phase 2 | |
Completed |
NCT00896493 -
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
|
Phase 2 | |
Completed |
NCT00211198 -
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
|
Phase 4 | |
Terminated |
NCT03601819 -
Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
|
Phase 1 | |
Withdrawn |
NCT03742804 -
Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma
|
Phase 2 | |
Completed |
NCT02836886 -
VircapSeq Virus Detection in Sézary Syndrome
|
||
Completed |
NCT00050999 -
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
|
Phase 4 | |
Terminated |
NCT02323659 -
Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
|
Phase 4 | |
Recruiting |
NCT02840747 -
Tissue Repository: CTCL Collection Protocol
|
||
Terminated |
NCT02811783 -
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
|
Phase 3 |