Actively Recruiting
Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
Led by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Updated on 2025-11-28
45
Participants Needed
15
Research Sites
371 weeks
Total Duration
On this page
Sponsors
G
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Lead Sponsor
K
Kite, A Gilead Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years.
CONDITIONS
Official Title
Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- Age greater than 18 years
- Ability to understand and speak one of the official languages of the study country
- Histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma Grade 3B as per WHO 2016 classification
- Indolent B-cell non-Hodgkin lymphoma transformed into aggressive B-cell lymphoma previously treated with R-CHOP-like therapy after transformation
- PET-positive disease
- Prior adequate first-line therapy including an anti-CD20 monoclonal antibody and CHOP or CHOP-like chemotherapy (excluding dose-reduced CHOP except for vincristine dose reduction due to neuropathy)
- Relapse occurring 12 months to 5 years after completion of first-line chemoimmunotherapy, documented by PET scan and biopsy
- Eligibility for CAR T-cell therapy as determined by physician and meeting criteria including ECOG performance status 0-2, adequate vascular access, sufficient blood counts, kidney function (CrCl ≥ 40 mL/min), liver function (ALT/AST ≤ 2.5x ULN), bilirubin <1.5 mg/dL (except Gilbert's syndrome), cardiac ejection fraction ≥ 45%, and oxygen saturation ≥ 92% on room air
- Negative pregnancy test for females of childbearing potential
You will not qualify if you...
- More than one prior line of systemic therapy
- Relapse occurring less than 12 months after first-line therapy (early relapse)
- Refractory disease defined as progression during first-line therapy, stable disease after at least 4 cycles, or partial response after at least 6 cycles with biopsy-proven residual disease
- Patients with prior R-CHOP or obinutuzumab-CHOP for indolent B-cell lymphoma who relapse as transformed aggressive lymphoma more than one year after first-line therapy
- Prior CD19 targeted therapy
- Cardiac lymphoma involvement
- Need for urgent therapy due to tumor mass effects like bowel obstruction or vessel compression
- Clinically significant pleural effusion
- History of other primary malignancy not in remission for at least 3 years (except certain skin cancers or in situ carcinomas)
- Active central nervous system lymphoma; history of CNS lymphoma allowed if no active disease
- CNS disorders including dementia, autoimmune CNS disease, cerebral edema with structural defects, or seizure disorders requiring active medication; recent stroke or related syndromes within past 12 months
- Presence of indwelling lines or drains except central venous catheters like Port-a-Cath or Hickman
- Active or untreated hepatitis B or C infection
- Positive HIV unless on treatment with undetectable viral load and CD4 > 200 cells/uL
- Uncontrolled infections despite treatment
- Significant cardiovascular events or disease within past 12 months
- Primary immunodeficiency
- Autoimmune disease requiring systemic immunosuppression within last year (maintenance physiologic steroids allowed)
- History of certain lung diseases or active pneumonitis
- Severe allergic reactions to study agents
- Recent live vaccine use within 6 weeks
- Pregnancy or breastfeeding
- Unwillingness to use birth control during treatment and for 12 months after
- Unlikely to complete study visits or comply with protocol
- Inability to provide informed consent due to intellectual, medical, or psychiatric reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain, 15008
Actively Recruiting
2
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 7120
Actively Recruiting
3
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
4
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain, 37007
Actively Recruiting
5
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
6
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
7
Institut Català d'oncologia de L'Hospitalet
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
Actively Recruiting
8
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, Spain
Actively Recruiting
9
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
Actively Recruiting
10
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
11
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
12
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain, 30008
Actively Recruiting
13
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
14
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
15
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
A
Auxi Moreno
CONTACT
A
Ana María Méndez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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