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ROMIDEPSIN IN COMBINATION WITH CHOEP AS FIRST LINE TREATMENT BEFORE HEMATOPOIETIC STEM CELL TRANSPLANTATION IN YOUNG PATIENTS WITH NODAL PERIPHERAL T-CELL LYMPHOMAS: A PHASE I-II STUDY
EU CTIS ID: 2024-511639-83-00
What this study is testing
Phase I: To define the maximum tolerated dose (MTD) of Ro-CHOEP-21 Phase II: To evaluate the efficacy in term of Progression Free Survival (PFS) of Ro-CHOEP-21
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age ≥18 e ≤ 65 years
- Levels of serum bilirubin, alkaline phosphatase and transaminases < 2 the upper normal limit, if not disease related
- No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- Ejection fraction > 50% and myocardial stroke in the last year nor QT prolongation (QTc interval < 480 msec using the Fridericia formula)
- Clearance of creatinine > 60 ml/min if not disease related
- Spirometry Diffusion Capacity (DLCO) > 50%
You likely can't join if
- age <18 e > 65 years
- Clearance of creatinine < 60 ml/min if not disease related
- Spirometry Diffusion Capacity (DLCO) < 50%
- Pregnancy or lactation
- Patient not agreeing to take adequate contraceptive measures during the study
- Psychiatric disease that precludes understanding concepts of the trial or signing informed consent
See the full eligibility criteria
- age ≥18 e ≤ 65 years
- Levels of serum bilirubin, alkaline phosphatase and transaminases < 2 the upper normal limit, if not disease related
- No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- Ejection fraction > 50% and myocardial stroke in the last year nor QT prolongation (QTc interval < 480 msec using the Fridericia formula)
- Clearance of creatinine > 60 ml/min if not disease related
- Spirometry Diffusion Capacity (DLCO) > 50%
- Absence of active, uncontrolled infection
- For males and females of child-bearing potential, agreement upon the use of effective contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment
- Availability of histological material for central review and pathobiological studies.
- Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL, ALK negative ALCL
- Stage II-IV
- Written informed consent
- No prior treatment for lymphoma
- No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
- HIV negativity
- Absence of active hepatitis C virus (HCV) infection
- HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/- with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory)
- age <18 e > 65 years
- Clearance of creatinine < 60 ml/min if not disease related
- Spirometry Diffusion Capacity (DLCO) < 50%
- Pregnancy or lactation
- Patient not agreeing to take adequate contraceptive measures during the study
- Psychiatric disease that precludes understanding concepts of the trial or signing informed consent
- Any active, uncontrolled infection
- Prior history of malignancies other than PTCLs in the last five years (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast).
- Hystology other than: PTCL-NOS, AITL, ALK negative ALCL
- Stage I
- Prior treatment for lymphoma
- Positive serologic markers for human immunodeficiency virus (HIV)
- Active hepatitis B virus (HBV) infection
- Active hepatitis C virus (HCV) infection
- Levels of serum bilirubin, alkaline phosphatase and transaminases > 2 the upper normal limit, if not disease related
- Ejection fraction < 50% and no myocardial stroke in the last year or QT prolongation (QTc interval > 480 msec using the Fridericia formula)
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.