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Prevention study for DLBCL - Diffuse Large B Cell Lymphoma
Official title Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
ClinicalTrials.gov ID: NCT06220032
What this study is testing
What is Dexrazoxane?
Dexrazoxane is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dlbcl - diffuse large b cell lymphoma.
Also referred to as Cardioxane.
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
- Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to WHO classification 2022:
- DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma NOS
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation when DA-EPOCH-R is not an option. R2- CHOP is allowed.
- Follicular lymphoma
You likely can't join if
- Any of the following B-cell lymphomas according to WHO classification 2022: o Central Nervous System involvement by DLBCL; Note: high CNS-IPI is...
- Testicular DLBCL;
- Primary mediastinal B-cell lymphoma;
- Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;
- Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is...
- Patients requiring treatment with mini-R-CHOP
See the full eligibility criteria
- Untreated patients with a confirmed histologic diagnosis of CD20+ DLBCL according to WHO classification 2022:
- DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma NOS
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocation when DA-EPOCH-R is not an option. R2- CHOP is allowed.
- Follicular lymphoma
- T-cell/histiocyte-rich B cell lymphoma (THRBCL) Note: Transformed, previously untreated lymphoma is allowed. Note: 5-day treatment of dexamethasone 15 mg/day or prednisone 100 mg/day or local radiotherapy in order to...
- Planned treatment with 6 R-CHOP21. The following regimens are also allowed:
- Treatment with reversed R-CHOP21
- Treatment with R2-CHOP21 (6 R-CHOP21 + lenalidomide 15 mg day 1-14) in case of double hit lymphoma
- Two additional administrations of rituximab after 6 cycles of R-CHOP21
- High dosis MTX and/or MTX-it for CNS prophylaxis
- Ann Abor stages II-IV and stage I if the treatment plan is 6 R-CHOP21 in case of bulky disease (defined as a ≥10 cm mass);
- Age ≥ 18 years;
- WHO performance status ≤ 2, WHO 3 performance status is allowed when considered directly related to the DLBCL;
- Negative pregnancy test at study entry for women of childbearing potential;
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agrees to practice two effective methods of contraception, at the same time...
- Male patient, even if surgically sterilized, (i.e., status post vasectomy) agrees to practice effective barrier contraception during the entire study period and through 12 months after the last dose of protocol...
- Patient is able to adhere to the study visit schedule and other protocol requirements;
- Written informed consent.
- Any of the following B-cell lymphomas according to WHO classification 2022: o Central Nervous System involvement by DLBCL; Note: high CNS-IPI is allowed
- Testicular DLBCL;
- Primary mediastinal B-cell lymphoma;
- Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder;
- Any prior malignancy or present malignancy other than DLBCL that required or requires systemic therapy. Prior surgery or local radiotherapy is allowed in case the heart has not been exposed.
- Patients requiring treatment with mini-R-CHOP
- Pre-existing cardiac disease including:
- LVEF \<50% measured with echocardiography (2D or 3D)
- Symptomatic heart failure (NYHA ≥II) or hospitalization for heart failure in the last year;
- Refractory anginal symptoms
- Cardiac arrhythmias not controlled with optimal medical treatment, in case of atrial fibrillation the ventricular response needs to be \<110/min;
- Significant valvular dysfunction on echocardiography;
- Non-ischemic cardiomyopathy
- Non-diagnostic/poor transthoracic echocardiography imaging quality at baseline;
- Severe pulmonary dysfunction defined as breathlessness at rest (COPD GOLD III or IV), unless clearly related to DLBCL;
- Severe neurological or psychiatric disease;
- Inadequate hematological function (absolute Neutrophil Count (ANC) \<1.0x109/L or platelets \<75x109/L), unless clearly related to DLBCL;
- Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal) unless related to lymphoma infiltration of the liver;
- Active hepatitis B or C infection (serology testing is required at screening). Patients positive for hepatitis B surface antigen (HBsAg) regardless of antibody status or HBsAg negative but anti-HBc positive are only...
- Significant renal dysfunction (creatinine clearance \< 30 ml/min after rehydration) or requiring dialysis;
- Active uncontrolled fungal, bacterial and/or viral infection;
- Patient known to be HIV-positive;
- Breast-feeding female patients;
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Participation in another clinical trial with anti-cancer therapy or a cardiovascular drug.
The study team makes the final eligibility decision.
Where it's taking place
- 's-Hertogenbosch, Netherlands
- Almelo, Netherlands
- Amstelveen, Netherlands
- Apeldoorn, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Delft, Netherlands
- Dordrecht, Netherlands
- Eindhoven, Netherlands
- Goes, Netherlands
- Groningen, Netherlands
- Harderwijk, Netherlands
- Hilversum, Netherlands
- Hoofddorp, Netherlands
- Nieuwegein, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Schiedam, Netherlands
- Sittard, Netherlands
- Sneek, Netherlands
+ 4 more site(s).
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 's-Hertogenbosch, Netherlands; Almelo, Netherlands; Amstelveen, Netherlands; Apeldoorn, Netherlands; Arnhem, Netherlands; Breda, Netherlands and 18 more location(s). 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.