Relapsed Follicular LymphomaPhase 2LOTIS-6NCT04699461
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma
A Phase 2 study testing Loncastuximab Tesirine and Idelalisib in people with Relapsed Follicular Lymphoma and Refractory Follicular Lymphoma, run by ADC Therapeutics S.A. at 34 sites in 10 countries.
Trial summary
This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma
- What is being tested?
- Loncastuximab Tesirine and Idelalisib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 4 Nov 2021to 25 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any study procedures.
- Male or female participants aged 18 years or older, with pathologic diagnosis of follicular lymphoma (FL) (Grade 1, 2, 3A) in the most recent tumor biopsy.
- Relapsed or refractory disease following two or more treatment regimens, at least one of which must have contained an anti-CD20 therapy.
- Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy.
- Measurable disease as defined by the 2014 Lugano Classification as assessed by positron emission tomography - computed tomography (PET-CT) or, if not Fluorodeoxyglucose (FDG) avid, CT or magnetic resonance imaging (MRI).
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available). Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
Show all 17Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate organ function as defined by screening laboratory values within the following parameters:
- Absolute neutrophil count (ANC) ≥1.0 × 10^3/μL (off growth factors at least 72 hours),
- Platelet count ≥75 × 10^3/μL without transfusion in the past 2 weeks,
- Alanine aminotransferase, AST, and GGT ≤2.5 × the upper limit of normal (ULN),
- Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN),
- Calculated creatinine clearance ≥30 mL/min by the Cockcroft and Gault equation. Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility
- Women of childbearing potential (WOCBP)(1) must agree to use a highly effective method(2) of contraception from the time of giving informed consent until at least 9 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 6 months after the participant receives his last dose of study treatment.
- WOCBP are defined as sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective forms of birth control include hormonal contraceptives associated with inhibition of ovulation (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the participant.
- Note: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception.
Who cannot join
- Previous treatment with loncastuximab tesirine.
- Previous treatment with idelalisib.
- History of hypersensitivity to any of the excipients of loncastuximab tesirine or idelalisib.
- Follicular lymphoma which has transformed to diffuse large B-cell lymphoma (DLBCL) or other aggressive lymphomas.
- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor, inducer, or sensitive substrate.
- History of or ongoing drug-induced pneumonitis.
Show all 31Show fewer
- History of or ongoing inflammatory bowel disease.
- Any condition that could interfere with the absorption or metabolism of idelalisib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
- Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary.
- Autologous transplant within 30 days prior to start of study treatment (C1D1).
- Allogenic transplant within 60 days prior to start of study treatment (C1D1).
- Active graft-versus-host disease.
- Post-transplantation lymphoproliferative disorders.
- Human immunodeficiency virus (HIV) seropositive with any of the following:
- CD4+ T-cell counts <350 cells/μL.
- Acquired immuno-deficiency syndrome (AIDS)-defining opportunistic infection within 12 months prior to screening.
- Not on anti-retroviral therapy, or on anti-retroviral therapy for < 4 weeks at the time of screening.
- HIV viral load ≥400 copies/mL.
- Serologic evidence of chronic hepatitis B infection and unable or unwilling to receive standard prophylactic anti-viral therapy or with detectable hepatitis B virus (HBV) viral load.
- Serologic evidence of hepatitis C infection without completion of curative treatment or with detectable hepatitis C virus (HCV) viral load.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Lymphoma with active central nervous system involvement, including leptomeningeal disease.
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
- Breastfeeding or pregnant.
- Significant medical comorbidities, including but not limited to, uncontrolled hypertension (BP ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
- Any Grade ≥3 active infection which requires IV antibiotics, IV antiviral, or IV antifungal treatment.
- Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study treatment (C1D1), except shorter if approved by the Sponsor.
- Use of any other experimental medication within 30 days prior to start of study treatment (C1D1).
- Live vaccine administration within 4 weeks prior to Cycle(C) 1 Day (D) 1.
- Failure to recover to ≤ Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non-hematologic toxicity (except ≤Grade 2 neuropathy or alopecia) due to previous therapy prior to screening.
- Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk.
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
Spain8 sites
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, 08908
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Hospital Universitario Ramón y Cajal
Madrid, 08908
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitario Virgen del Rocío
Seville, 41013
United States5 sites
Hollings Cancer Center
Charleston, South Carolina, 29425
Summit Medical Group - Florham Park Campus
Florham Park, New Jersey, 07932
Summit Medical Group
Florham Park, New Jersey, 07932
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Israel5 sites
Soroka Medical Center
Beersheba, 8410101
Carmel Medical Center
Haifa, 3436212
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492
The Chaim Sheba Medical Center
Tel Aviv, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
France4 sites
Centre Hospitalier de Dunkerque
Dunkirk, 59385
Centre Hospitalier de La Rochelle
La Rochelle, 17000
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel
Rouen, 76038
Hôpital Bretonneau
Tours, 37044
Hungary3 sites
Semmelweis Egyetem
Budapest, 1088
Országos Onkológiai Intézet
Budapest, 1122
Pécsi Tudományegyetem Klinikai Központ
Pécs, 7624
Poland3 sites
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
Gdynia, 81-519
Pratia Onkologia Katowice
Katowice, 40-519
Pratia Poznań
Skorzewo, 60-185
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent, 9000
Centre Hospitalier Universitaire Universite Catholique de Louvain
Yvoir, B-5530
United Kingdom2 sites
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF
Account University College London Hospitals NHS Foundation Trust
London, NW1 2PG
About this study
Official title: A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients With Relapsed or Refractory Follicular Lymphoma (LOTIS-6)
This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.
- Being tested
- Loncastuximab Tesirine, Idelalisib
- Keywords
- Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma, Loncastuximab Tesirine, Follicular Lymphoma, Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab TesirineDrug
Also called Zynlonta, ADCT-402
IV infusion
IdelalisibDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Loncastuximab Tesirine | Experimental | Participants will be administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. Receives: Drug: Loncastuximab Tesirine |
| Idelalisib | Active comparator | Participants will be administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
CRR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR) assessed prior to any subsequent anticancer treatment.
Measured: Up to the end of treatment, maximum time on treatment was 333 days
Secondary outcomes (14)
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a BOR of CR or partial response (PR) assessed prior to any subsequent anticancer treatment.
Measured: Up to end of treatment, maximum time on treatment was 333 days
Progression-Free Survival (PFS)
PFS was defined as the time between the randomization date and the first documentation of recurrence, progression, or death.
Measured: Up to end of treatment, maximum time on treatment was 333 days
Overall Survival (OS)
OS was defined as the time between the randomization date and death from any cause.
Measured: Up to end of treatment, maximum time on treatment was 333 days
Duration of Response (DOR)
DOR was defined as the time from the documentation of tumor response to disease progression or death.
Measured: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
TEAEs were defined as an AE that occurs or worsens in the period extending from the first dose of study treatment until 30 days after the last dose of study treatment or start of new anti-cancer therapy, whichever is earlier.
Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Measured: Day 1 to 30 days after end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine Before Infusion
Measured: Up to end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Measured: Up to end of treatment, maximum time on treatment was 333 days
Clearance Rate of Loncastuximab Tesirine
Measured: Up to end of treatment, maximum time on treatment was 333 days
Volume of Distribution of Loncastuximab Tesirine
Measured: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Measured: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Measured: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Measured: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Specific Symptomatic Adverse Event Symptoms As Selected From Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The specific symptomatic adverse events includes fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough.
Measured: Up to end of treatment, maximum time on treatment was 333 days
Treatment-Related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The specific symptoms assessed include fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much."
Measured: Up to end of treatment, maximum time on treatment was 333 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start4 Nov 2021
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Why it stopped: Administrative decision (not due to safety reason)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADC Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699461
- Sponsor's protocol ID
- ADCT 402-202
- Other IDs
- 2020-003695-40
- Acronym
- LOTIS-6
- Status last verified
- Sep 2023
- First submitted
- 5 Jan 2021
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients With Relapsed or Refractory Follicular Lymphoma (LOTIS-6)
- ClinicalTrials.gov ID
- NCT04699461
- Acronym / sponsor ID
- LOTIS-6 / ADCT 402-202
- Keywords
- Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma, Loncastuximab Tesirine, Follicular Lymphoma, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative decision (not due to safety reason)
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loncastuximab Tesirine | Experimental | Drug: Loncastuximab TesirineParticipants will be administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine will be administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. |
| Idelalisib | Active comparator | Drug: IdelalisibParticipants will be administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written informed consent must be obtained prior to any study procedures.
- Male or female participants aged 18 years or older, with pathologic diagnosis of follicular lymphoma (FL) (Grade 1, 2, 3A) in the most recent tumor biopsy.
- Relapsed or refractory disease following two or more treatment regimens, at least one of which must have contained an anti-CD20 therapy.
- Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy.
- Measurable disease as defined by the 2014 Lugano Classification as assessed by positron emission tomography - computed tomography (PET-CT) or, if not Fluorodeoxyglucose (FDG) avid, CT or magnetic resonance imaging (MRI).
Key exclusion criteria (31 listed)
- Previous treatment with loncastuximab tesirine.
- Previous treatment with idelalisib.
- History of hypersensitivity to any of the excipients of loncastuximab tesirine or idelalisib.
- Follicular lymphoma which has transformed to diffuse large B-cell lymphoma (DLBCL) or other aggressive lymphomas.
- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor, inducer, or sensitive substrate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loncastuximab TesirineAlso: Zynlonta, ADCT-402IV infusion | Drug | Loncastuximab Tesirine |
| IdelalisibOral tablet | Drug | Idelalisib |
Primary outcome
Complete Response Rate (CRR)
Time frame: Up to the end of treatment, maximum time on treatment was 333 days
CRR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR) assessed prior to any subsequent anticancer treatment.
14 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Progression-Free Survival (PFS)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Overall Survival (OS)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Duration of Response (DOR)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 to 30 days after end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine Before Infusion
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Clearance Rate of Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Volume of Distribution of Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Number of Participants With Specific Symptomatic Adverse Event Symptoms As Selected From Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Treatment-Related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to end of treatment, maximum time on treatment was 333 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Relapsed Follicular Lymphoma
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loncastuximab Tesirine and Idelalisib in people with Relapsed Follicular Lymphoma and Refractory Follicular Lymphoma, run by ADC Therapeutics S.A. at 34 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Spain, United States, Israel, France, Hungary and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: Up to the end of treatment, maximum time on treatment was 333 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.