NCT06893783Phase 2Recruiting
Inkeun Park · Asan Medical Center, Seoul
This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.
Eligibility: 19 Years to · All · \- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
* Age ≥19 years at the time of signing the informed consent.
* Histologically confirmed relapsed/refractory extra-pulmonary neuroendocrine carcinoma. Neuroendocrine carcinoma includes small cell carcinoma, large cell carcinoma, and mixed histology of neuroendocrine and other histology (e.g., adenoneuroendocrine carcinoma, urothelial carcinoma with neuroendocrine component). In patients with prostate cancer, treatment-emergent neuroendocrine carcinoma (initially adenocarcinoma, but transdifferentiate into neuroendocrine carcinoma after androgen deprivation therapy) will be permitted.
* Cohort 1 (gastrointestinal and pancreaticobiliary cohort): cancers originated from stomach, esophagus, small intestine, colorectal, pancreas, or bile ducts.
* Cohort 2 (genitourinary cohort): cancers originated from prostate, bladder, ureter, urethra, or kidney.
* Subject has progressed or recurred following 1 platinum-based regimen:
* documented first disease progression must be during or following first-line platinum-based systemic chemotherapy. For patients with prostate cancer, especially in cases with treatment-emergent neuroendocrine carcinoma, platinum-based chemotherapy will not need to be the first line therapy.
* patients who received treatment for localized disease who recur are eligible
* patients who received adjuvant Platinum-Etoposide (EP) after resection of their primary tumor who recur are eligible
* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Screening scans performed as SOC(Standard of Care) and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period, provided that informed consent for the use of these scans is obtained prior to any transfer of data.
* In patients with prostate cancer, patients without RECIST-defined measurable lesion can be included, if disease can be evaluated with Prostate Cancer Working Group(PCWG)-3 criteria.
* Eastern Cooperative Oncology Group (ECOG) PS(Performance Status) of 0 - 2.
* Minimum life expectancy of 12 weeks.
* Adequate organ function, defined as follows:
• Hematological function: Absolute neutrophil count ≥ 1.5 x 10\^9 /L Platelet count ≥ 100 x 10\^9/L Hemoglobin \> 9 g/dL (90 g/L)
• Coagulation function: Prothrombin Time (PT)/International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) or activated Partial Thromboplastin Time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects undergoing new class anticoagulant therapy (eg, Edoxaban), stable dose for 2 weeks required prior to enrollment.
• Renal function: estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL/min/1.73 m\^2 or creatinine clearance ≥ 30 mL/min as determined by Cockcroft-Gault equation (Cockcroft and Gault 1976)
• Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN (or \<5 x ULN for subjects with liver involvement) total bilirubin (TBL) \<1.5 x ULN (\<2 x ULN for subjects with liver involvement) (except participants with Gilbert syndrome who must have total bilirubin \<3.0 mg/dL)
• Pulmonary function: no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (eg, PleurX) are allowed baseline oxygen saturation \>90% on room air
• Cardiac function: cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings Provision of evaluable tumor samples for central testing (archival or in-study biopsy)
NCT06313957Phase 1Recruiting
Peking University Cancer Hospital & Institute · Beijing GoBroad Boren Hospital, Beijing, Beijing Municipality
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Eligibility: 18 Years to · All · * Subjects voluntarily participate in clinical research;
* Age ≥18 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
* At least one measurable tumor lesion according to the Lugano 2014.
* Expected survival ≥3 months;
* Clinical laboratory values in the screening period meet criteria.
* Effective contraception.
NCT07684131Phase IIRecruiting
Versailles Hospital · Groupe hospitalier sud, Amiens
An observatory for patients aged 18 years and over with Philadelphia chromosome positive (Ph+ or BCR::ABL1) acute lymphoblastic leukemia (ALL) and treated with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticosteroids and/or a monoclonal antibody.
Eligibility: 18 Years to · All · 1. Male or female patients ≥ 18 years
2. Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia
3. Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody
NCT04083495Phase 2Recruiting
UNC Lineberger Comprehensive Cancer Center · Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, North Carolina
This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated. T cells will be genetically modified in a laboratory at UNC-Chapel Hill to enable them to produce CD30 antibody. The modified T cells, called ATLCAR.CD30, will be able to target and attach to lymphoma cancer cells that carry the CD30 antigen. Once they are attached, the hope is that the T cells will attack and destroy the lymphoma cancer cells. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Lymphodepletion will happen over three days prior to ATLCAR.CD30 infusion. If participants respond to this treatment, and there are sufficient unused ATLCAR.CD 30 cells, they may be eligible to receive a second infusion. The second infusion will be given after a second lymphodepletion chemotherapy. Most of the clinic visits in this research will last between 1-8 hours.
There are risks associated in participating in this research study. Risks of treatment include infection, fever, nausea, vomiting, neurotoxicity, and cytokine release syndrome which can include low blood pressure or difficulty breathing. Other risks are associated with study procedures, such as biopsies, imaging, infusion, and breach of confidentiality.
Eligibility: 18 Years to 99 Years · All · Inclusion Criteria for the Study
1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of \>60%
4. Histological or cytological evidence/confirmation of CD30+ peripheral T-cell lymphoma per the 2017 World Health Organization Classification of Haematopoietic and Lymphoid Tissues.
5. CD30+ disease determined via archival tissue after the subject's most recent anti-CD30 therapy prior to ATLCAR.CD30 (result can be pending at the time of cell procurement but must be confirmed prior to treatment with the first infusion of ATLCAR.CD30 cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard.
6. Any subjects who has received at least two prior lines of therapy for their lymphoma. If transplant is given as a preplanned consolidation in first remission, it will not be counted as a second line of therapy.
7. Any subject who has received one line of therapy who has primary refractory lymphoma or lymphoma that relapsed within 12 months of completing chemotherapy or receiving transplant as long as prior therapy included brentuximab vedotin unless they were not candidates for brentuximab vedotin.
8. Subjects relapsed after autologous stem cell transplant are eligible for this study.
9. Subjects relapsed after allogeneic stem cell transplantation are eligible provided the patient is ≥180 days from transplant, not on immunosuppresive therapy to treat/prevent graft-versus-host disease and has no evidence of active graft-versus-host disease.
10. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
11. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. Note: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
12. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \<1% failure rate for protection from pregnancy in the product label. Women of childbearing potential will also be instructed to tell their male partners to use a condom.
13. Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Exclusion Criteria for the Study
1. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study ).
2. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \<10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed.
3. Active infection with HIV, HTLV, HCV (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibody or PCR negative for HTLV1 and 2, negative for HCV antibody or HCV viral load.
4. Subjects who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infecti
NCT06514794Phase 2Recruiting
Allotera Therapeutics · City of Hope, Duarte, California
The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response
Eligibility: 6 Months to · All · Key
* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive
* Age: Lower age limit of ≥ 6 months; adequate organ function
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
Key
NCT07305337NARecruiting
Zhongnan Hospital · Zhongnan Hospital of Wuhan University, Wuhan, Hubei
With the rapid advancement of biopharmaceutical technology, clinical trials have become the crucial bridge connecting new drugs from the laboratory to clinical application. Despite the increasing number of clinical trial projects being conducted, nearly all such projects face the common challenge of recruitment difficulties. Subject recruitment constitutes a pivotal stage in clinical trials; the ability to recruit a sufficient number of subjects meeting the trial requirements significantly impacts trial quality and also serves as a key factor influencing trial progress. Hematologic cancers constitute a highly heterogeneous group of malignant diseases originating in the haematopoietic organs and primarily affecting the haematopoietic system. They encompass acute and chronic leukaemias, malignant lymphomas, multiple myeloma, myelodysplastic syndromes, and related disorders. For patients facing treatment decisions, clinical trials represent not only a vital avenue for accessing cutting-edge therapies but also impose heightened demands on their capacity for informed decision-making. Conversational artificial intelligence (AI) based on large language models is rapidly advancing in health education and public health communication. Medical chatbots offer scalable and personalised advantages in delivering health information, promoting behavioural change, and enhancing patient engagement, providing a viable pathway for improving trial literacy and decision support. Accordingly, this study proposes to conduct a clinical trial literacy intervention using AI-powered chatbots among haematological malignancy patients. Through a randomised controlled trial (RCT), it aims to evaluate the impact of AI-assisted health education on patients' understanding of clinical trials and intention to participate. This research seeks to validate the application value of AI technology in health education and explore scalable AI-assisted health education intervention models.
Eligibility: 18 Years to 90 Years · All · Inclusion Criteria (1) Aged ≥18 years with clear consciousness; (2) Diagnosed with haematological malignancy meeting clinical treatment criteria (WHO criteria); (3) Capable of understanding health education content and possessing basic communication skills; (4) Willing to participate in this study and sign an informed consent form.
Exclusion Criteria
(1) Patients with concomitant cognitive impairment, psychiatric disorders, or other conditions severely affecting comprehension; (2) Anticipated hospital stay of less than 3 days, rendering completion of the intervention unfeasible; (3) End-of-life palliative care; (4) Previous participation in other clinical trial education programmes.
NCT07782944NARecruiting
Guilin Medical University, China · The First Affliated Hospital of Guilin Medical University, Guilin, Guangxi
The objective of the study is to construct a noninvasive approach CD38 targeted PET/CT to detect tumor lesions in patients with Multiple Myeloma and to compare with FDG PET/CT.
Eligibility: 18 Years to · All · * Adult patients (aged 18 years or older);
* Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of Multiple Myeloma (supporting evidence may include MRI, CT, tumor markers, and pathology report);
* Patients who had scheduled both standard-of-care imaging (FDG PET/CT) and cd38 PET/CT scans;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
NCT06494371Phase 1Recruiting
Ruijin Hospital · Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
Eligibility: 18 Years to 75 Years · All · 1. Subjects voluntarily participate in clinical research.
2. Aged 18 to 75 years, either sex.
3. Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
4. Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
6. Expected survival ≥3 months.
7. Clinical laboratory values in the screening period meet criteria.
8. Effective contraception.
NCT05099471Phase 2Recruiting
Christian Buske · Onkologische Schwerpunktpraxis Bielefeld, Bielefeld
In Waldenström's macroglobulinemia (WM) chemotherapy induces only low CR/VGPR rates and response duration is limited. In addition, WM patients are often elderly, partly not tolerating chemotherapy related toxicities. Thus, innovative approaches are needed which combine excellent activity and tolerability in WM. Chemotherapy-free approaches are highly attractive for this patient group. Based on its high activity and favorable toxicity profile in indolent B-NHL such as CLL, Venetoclax was approved for the treatment of this diseases by the FDA and the European Medicines Agency (EMA). First data in relapsed/refractory WM have documented high activity and low toxicity of Venetoclax also in WM, including patients with prior Ibrutinib treatment or patients carrying CXCR4 mutations. Ibrutinib itself has high activity and a relatively low toxicity profile in WM, but has also major disadvantages: the main disadvantage is the need to apply this drug continuously. Furthermore, Ibrutinib efficacy depends largely on the genotype with a substantial drop in major responses and PFS in the presence of CXCR4 mutations and non-mutated MYD88. In particular the need of continuous treatment for Ibrutinib has prevented that Ibrutinib has become the standard of care outcompeting conventional Rituximab/chemotherapy. This is reflected in current guidelines such as the NCCN and the ESMO guidelines, which still see immunochemotherapy as a backbone of treatment, largely because of the advantage of a timely fixed application. Data in CLL in the relapsed as well as in the first line setting have convincingly shown that in contrast to Ibrutinib Venetoclax is highly efficient also when used in a timely defined application scheme over 12 months in combination with the anti-CD20 antibody Rituximab. Data documented deep responses including molecular responses and a highly significant advantage over immunochemotherapy in large international Phase III trials, changing the standard of care in this disease.
Based on this the hypothesis is that timely fixed application of the combination of Venetoclax and Rituximab induces significantly superior treatment outcomes compared to chemotherapy and Rituximab (DRC) in patients with treatment naïve WM, regardless of the genotype. A first indication for this assumption in the proposed trial will allow the performance of confirmatory phase 3 trials that might change the standard of care in WM.
Eligibility: 18 Years to · All · * Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM (IWWM). Histopathology has to be perfomed before randomization but within the last 4 months before start of treatment. In addition, pathological specimens have to be sent to the national pathological reference center prior to randomization for the determination of the mutational status of MYD88 and CXCR4 prior to randomization if the mutational status hasn't been determined before. Pathological reference center must confirm the diagnosis of WM.
* De novo WM independent of the genotype.
* Patients must have at least one of the following criteria to start study treatment as partly defined by consensus panel criteria from the Seventh IWWM and ESMO Guideline:
* Recurrent fever, night sweats, weight loss, fatigue (at least one of them).
* Hyperviscosity.
* Lymphadenopathy which is either symptomatic or bulky (≥ 5 cm in maximum diameter).
* Symptomatic hepatomegaly and / or splenomegaly.
* Symptomatic organomegaly and / or organ or tissue infiltration.
* Peripheral neuropathy due to WM.
* Symptomatic cryoglobulinemia.
* Symptomatic Cold agglutinin anemia.
* Autoimmune hemolytic anemia and/or thrombocytopenia.
* Nephropathy related to WM.
* Amyloidosis related to WM.
* Hemoglobin ≤ 10 g/dL (patients should not have received red blood cells transfusions for at least 7 days prior to obtaining the screening hemoglobin).
* Platelet count \< 100 x 109/L (caused by bone marrow \[BM\] infiltration of the lymphoma).
* Serum monoclonal protein \> 5 g/dL, even with no overt clinical symptoms.
* IgM serum concentration ≥ 6 g/dL.
* and other WM associated relevant symptoms
* Subject must be ≥ 18 years of age.
* Life expectancy \> 3 months.
* World Health Organization (WHO) / ECOG performance status ≤ 2.
* Left ventricular ejection fraction ≥ 40% as assessed by transthoracic echocardiogram (TTE).
* Baseline platelet count ≥ 50x109/L, absolute neutrophil count ≥ 0.75x109/L (if not due to BM infiltration by the lymphoma).
. Adequate hepatic function per local laboratory reference range as follows:
* Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x ULN.
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).
* Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
* Women of childbearing potential (WCBP), i.e. fertile, following menarche and until becoming postmenopausal must have negative results for pregnancy test and must agree to use a highly effective method of birth control for the duration of the therapy up to 12 months after end of therapy
* Men must agree not to father a child for the duration of therapy and 12 months after and must agree to advice their female partner to use a highly effective method of birth control. Males must refrain from sperm donation for the duration of treatment and at least 12 months after the last dose of study medication.
* Each patient must voluntarily date and sign an informed consent form in the native language of the patient indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
* Affiliation to a social security scheme (relevant for France only).
NCT07109219Phase 1, Phase 2Recruiting
AstraZeneca · Research Site, Duarte, California
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility: 12 Years to · All · * 1\. Age:
* 16 years old in Module 1 (US only: ≥18year)
* 12 years old in Module 2
2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
* Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL
3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)
4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
5\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.
* Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI
6\. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks
NCT07678229Phase 3Recruiting
Rong Tao · Fudan University Shanghai Cancer Center,, Shanghai, Shanghai Municipality
This is a randomized, open-label, prospective, multicenter phase III superiority study in patients with newly diagnosed stage IV extranodal NK/T-cell lymphoma. The study compares two frontline induction strategies followed by consolidation with autologous hematopoietic stem cell transplantation in patients who achieve a protocol-defined strict complete remission.
Eligible participants will be randomized 1:1 to Arm A or Arm B, stratified by three-level PINK-E risk category. Arm A consists of one cycle of GELAD induction followed by three cycles of MEDA chemotherapy. Participants who achieve strict complete remission after key response assessment will proceed to autologous hematopoietic stem cell transplantation consolidation. Arm B consists of four cycles of LEAP induction with sintilimab, pegaspargase, and anlotinib. Participants who achieve strict complete remission will receive high-dose methotrexate CNS-directed consolidation followed by autologous hematopoietic stem cell transplantation consolidation if eligible.
The primary endpoint is event-free survival within 24 months after randomization. Secondary endpoints include progression-free survival, overall survival, overall response rate, complete remission rate, strict complete remission rate, autologous hematopoietic stem cell transplantation completion rate, cumulative incidence of relapse, grade 3 or higher adverse events, treatment discontinuation, treatment-related mortality, and plasma EBV-DNA clearance dynamics.
Eligibility: 18 Years to 70 Years · All · * Age 18 to 70 years at the time of signing informed consent.
* Histologically confirmed extranodal NK/T-cell lymphoma according to the current classification criteria, with tumor tissue confirmed to be EBER positive. Central pathology review is recommended.
* Stage IV disease according to Lugano 2014 staging criteria, with baseline staging including PET/CT and bone marrow evaluation.
* Previously untreated disease, with no prior systemic anti-lymphoma therapy, radiotherapy, or other anti-tumor treatment for NKTCL.
* At least one evaluable lesion assessable by PET/CT and/or contrast-enhanced CT/MRI.
* Eastern Cooperative Oncology Group performance status score of 0 to 3.
* Adequate hematologic function during screening, defined as absolute neutrophil count ≥1.0 × 10\^9/L, hemoglobin \>80 g/L, and platelet count \>50 × 10\^9/L.
* Adequate hepatic and renal function during screening, defined as alanine aminotransferase and aspartate aminotransferase ≤2 × upper limit of normal, total bilirubin ≤2 × upper limit of normal, and creatinine clearance ≥60 mL/min.
* No severe uncontrolled coagulation disorder, and judged by the investigator to be able to receive pegaspargase-containing therapy.
* Judged by the investigator to have no absolute contraindication to key components of the assigned treatment strategy, including irreversible contraindication to high-dose methotrexate, severe organ dysfunction precluding transplant evaluation, or other conditions clearly preventing completion of the protocol-defined strategy.
* Written informed consent provided by the participant or legally authorized representative.
NCT05849857Phase 2Recruiting
Oslo University Hospital · Helsinki University Hospital, Helsinki
In this clinical trial adult patients diagnosed with follicular lymphoma and relapse or progression of disease within 24 months of starting first line treatment will be treated with mosunetuzumab. This is a bispecific antibody, a new type of immunotherapy that redirects the bodies own immune cells (T-cells) to attack and kill the lymphoma cells. The main question the trial aims to answer is if mosunetuzumab works better than standard treatments in this sub-group of patients. Patients will receive mosunetuzumab as injections in the abdominal subcutaneous fat once a week for the three first doses, then every third week 7 times. If all signs of disease are gone as evaluated by PET-CT images, the treatment is stopped. If signs of disease remain on PET-CT images, the patients can receive treatment every third week for up to a total of one year. After the end of treatment, patients are followed two years in the trial for signs of progression or relapse.
Eligibility: 18 Years to · All · 1. Written informed consent according to ICH-GCP guidelines.
2. Age ≥ 18 years.
3. Follicular lymphoma grade 1-3a with a current relapse or progression within 24 months of starting 1st line treatment or refractory to 1st line treatment (POD24), more specifically:
1. Documented current relapse or progression of FL within 24 months of starting first line treatment containing a monospecific anti-CD20 antibody (such as rituximab or obinutuzumab with or without chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide).
2. Current lack of response/refractoriness to first line treatment, i.e., no objective response or documented progression within 6 months following at least four cycles of monotherapy with a monospecific anti-CD20 antibody (such as rituximab 375mg/m2 iv or 1400 mg SC or equal) or following at least three cycles of a monospecific anti CD20 antibody combined with chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide.
3. Received one prior treatment line of systemic therapy.
4. Patients may have had a period of watch and wait before the initiation of first line treatment.
5. Patients may have received localized radiotherapy previously.
4. At least one two-dimensionally measurable lesion with a longest diameter \>15mm.
5. WHO performance status 0-2. Patients with reduced WHO performance status (\> 2) can be considered if reduction in performance is caused by the lymphoma as determined by the investigator.
