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LymphomaPhase 1/2FUSION NHL 001NCT02733042

A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

A Phase 1/2 study testing Durvalumab, Lenalidomide and Rituximab in people with Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, run by Celgene at 66 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
66 sitesin 7 countries
Study dates
11 May 2016to 21 Aug 2022
Phase
Phase 1/2
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

  • Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
  • Subject who has high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
  • Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
  • Subject who has the Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
  • Subject who is willing and able to undergo biopsy.
  • Subject who has documented active relapsed or refractory disease requiring therapeutic intervention.
  • Subject with lymphoma who has measurable disease (≥ 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
  • Subject who fulfills the laboratory requirements as per protocol

Who cannot join

  • Subject who has central nervous system (CNS) or meningeal involvement by lymphoma.
  • Subject who has any histopathologic finding consistent with myelodysplastic syndrome on bone marrow studies.
  • Subject who received any prior monoclonal antibodies against programmed cell death-1 (PD-1) or programmed cell death ligand-1 (PD-L1) and/or any prior:
  • Arm A only: drugs with immunomodulatory and other properties (eg, lenalidomide, thalidomide);
  • Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
  • Arms C only: bendamustine
Show all 12Show fewer
  • Subject who has active auto-immune disease.
  • Subject who has history of organ transplant or allogeneic hematopoietic stem cell transplantation.
  • Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
  • Subject who has known seropositivity for or active infection for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
  • Subject who has history of primary immunodeficiency or tuberculosis.
  • Subject who other invasive malignancy within 2 years (5 years for Arm A) except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured.

Trial locations and contacts

66 sites in 7 countries.

66 sites in 7 countries

United States19 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbus, Ohio, 43210

  • Shands Cancer Center University of Florida

    Gainesville, Florida, 32610

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Jefferson Medical Oncology Associates

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Local Institution - 005

    Rochester, New York, 14642

  • University of Rochester

    Rochester, New York, 14642

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

France13 sites

  • Centre Hospitalier Universitaire d'Avicennes

    Bobigny, 93009

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Hospitalier

    Dijon, 21079

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU Montpellier

    Montpellier, 34295

  • Local Institution - 102

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Local Institution - 105

    Nantes, 44093

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Local Institution - 103

    Pierre-Bénite, 69495

  • CHRU Rennes

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

United Kingdom11 sites

  • St James University Hospital

    Leeds, LS9 7TF

  • UCL Cancer Institute

    London, WC1E 6BT

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Local Institution - 404

    Manchester, M20 4BX

  • Local Institution - 407

    Nottingham, Nottinghamshire, NG5 1PB

  • Nottingham University Hospitals NHS Trust

    Nottingham, Ng5 1PB

  • Local Institution - 406

    Oxford, 0X3 7LE

  • Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine

    Oxford, 0X3 7LE

  • Local Institution - 402

    Plymouth, Devon, PL6 8DH

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy9 sites

  • University of Bologna

    Bologna, 40138

  • Local Institution - 306

    Brescia, 25123

  • Spedali Civili Di Brescia

    Brescia, 25123

  • IEO- Istituto Europeo di Oncologia

    Milan, 20144

  • A.O. Ospedale Ca Granda - Niguarda

    Milan, 20162

  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

    Napoli, Campania, 80131

  • Local Institution - 304

    Napoli, Campania, 80131

  • I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

  • IRCCS Humanitas Clinical Institute

    Rozzano (milano), 20089

Other trials in Italy

Germany5 sites

  • Universitatsklinikum Essen

    Essen, 45122

  • UKG Universitatsklinikum Gottingen

    Göttingen, 37099

  • Universitatsklinikum des Saarlandes

    Homburg-Saar, 66421

  • Universitatsklinik Koln

    Köln, 50924

  • Medizinische Klinik III Klinikum der Universität München-Großhadern

    München, 81377

Other trials in Germany

Netherlands5 sites

  • VU Academic Medical Center, Amsterdam

    Amsterdam, 1081 HV

  • UMC Groningen

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Erasmus Medical Center

    Rotterdam, 3015 CN

  • Local Institution - 501

    Rotterdam, 3015 CN

Other trials in Netherlands

Japan4 sites

  • Local Institution - 602

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • Tokai University Hospital

    Isehara City, Kanagawa, 259-1193

  • Aichi Cancer Center

    Nagoya, 464-8681

Other trials in Japan

About this study

Official title: A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

Read the detailed description

The study was to consist of 3 parts: dose-finding, dose-confirmation, and dose-expansion. In this study, 4 treatment arms were to be investigated:

  • Arm A: durvalumab and lenalidomide ± rituximab
  • Arm B: durvalumab and ibrutinib
  • Arm C: durvalumab and rituximab ± bendamustine
  • Arm D: durvalumab (monotherapy)

The study was to start with 3 dose-finding cohorts (Arms A, B, and C) and 1 dose-confirmation cohort (Arm D) in parallel. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms. For Arms A and C, prior to enrolling participants to receive all 3 drugs, the doublet combinations were to be evaluated. Once the doublet combinations were deemed tolerable, the eventual triplet combinations were to be tested.

On 05 September 2017, the US FDA issued a Partial Clinical Hold on the study Arm A. Following this Partial Clinical Hold no more participants were enrolled into study Arm A. Participants already enrolled and treated in Arm A who were receiving clinical benefit, based on the discretion of the investigator, could continue study treatment after being reconsented. Arm B and C completed dose confirmation. The dose expansion part of the study was not opened.

Keywords
Lymphoma, Chronic Lymphocytic Leukemia, Durvalumab, Anti-PD-L1 Antibody, MEDI4736, Immune Checkpoint, Lymphatic Disease, B-Cell Malignancies, Abscopal Effect, Lenalidomide, Bendamustine, Rituximab, Ibrutinib, Lymphoma, B-Cell, Lymphoma, Non Hodgkin,, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell,, Lymphoma, Follicular, Lymphoma, Diffuse Large B-Cell, Lymphoma, Mantle Cell
Medical subject headings
Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphatic Diseases, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called MEDI4736, IMFINZI®

    Administered as an IV infusion (250 mL) over approximately 1 hour in duration

  • LenalidomideDrug

    Also called Revlimid®

    Administered orally

  • RituximabDrug

    Also called Rituxan®, MabThera®

    Administered by intravenous infusion

  • IbrutinibDrug

    Also called Imbruvica®

    Administered orally

  • BendamustineDrug

    Also called Treanda®, Bendeka®, Levact®

    Administered as a 30-minute intravenous infusion

Study groups in NCT02733042
Study groupRoleWhat they receive
Arm A: Durvalumab + Lenalidomide ± RituximabExperimentalParticipants assigned to Arm A will receive: * Durvalumab 1500 mg intravenous (IV) infusion on Day 1 of Cycles 1 through 13 (ie, 12 months) and * Lenalidomide orally at assigned dose levels (10 mg, 15 mg or 20 mg) once daily on Days 1 to 21 of: * Cycles 1 through 13 in indolent non-Hodgkin's lymphoma (NHL) or * All cycles of treatment period until disease progression, unacceptable toxicity, or discontinuation for any other reason in aggressive NHL * Rituximab 375 mg/m² IV infusion every week in Cycle 1 (Days 2, 8, 15, 22) and on Day 1 of Cycles 2 through 5. All treatment cycles were 28 days.
Receives: Drug: Durvalumab; Drug: Lenalidomide; Drug: Rituximab
Arm B: Durvalumab + IbrutinibExperimentalParticipants assigned to Arm B will receive: * Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 * Ibrutinib orally at assigned dose levels (280 mg, 420 mg, or 560 mg) once daily until disease progression, unacceptable toxicity or discontinuation for any other reason. All treatment cycles were 28 days.
Receives: Drug: Durvalumab; Drug: Ibrutinib
Arm C: Durvalumab + Rituximab ± BendamustineExperimentalParticipants assigned to Arm C will receive: * Durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13 * Rituximab 375 mg/m² IV infusion on Day 2 of Cycles 1 through 6 (for CLL the rituximab dose will be 375 mg/m² Cycle 1 first dose and 500 mg/m² for each subsequent dose) * Bendamustine IV infusion at assigned dose levels (70 mg/m² or 90 mg/m²) on Days 1 and 2 of Cycles 1 through 6. All treatment cycles were 28 days.
Receives: Drug: Durvalumab; Drug: Rituximab; Drug: Bendamustine
Arm D: Durvalumab MonotherapyExperimentalParticipants assigned to Arm D will receive durvalumab 1500 mg IV infusion on Day 1 of Cycles 1 through 13. All treatment cycles were 28 days.
Receives: Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

    Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion • Grade 4 anemia, unexplained by underlying disease • Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours. Non-Hematologic DLT • Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management • Any treatment interruption greater than 2 weeks due to adverse event.

    Measured: Cycle 1 (28 days)

  2. Number of Participants With Treatment-emergent Adverse Events

    Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).

    Measured: From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the data cut-off date of 6 March 2019. Maximum time on treatment was 55.4 weeks for DUR and 130 weeks for other study drugs.

Secondary outcomes (19)

  1. Overall Response Rate (ORR) During Durvalumab Treatment

    For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

    Measured: Up to 13 cycles (12 months)

  2. Overall Response Rate During the Entire Study

    For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification) (Cheson, 2014). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR). For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percentage of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL).

    Measured: From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

  3. Time to First Response

    Time to response was calculated as the time from first dose of study drug to the first response date (CR or PR for lymphoma participants and CR, CRi, nPR, PR, or PRL for CLL participants).

    Measured: From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

  4. Kaplan-Meier Estimate of Duration of Response

    Duration of response is defined for responders only as the time from the first documented response (CR or PR for lymphoma participants or CR, CRi, nPR, PR, or PRL for CLL participants) to disease progression or death (from any cause). For participants with response but no progression, or death, duration of response was censored at the last date that the participant was known to be progression-free.

    Measured: From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

  5. Kaplan-Meier Estimate of Progression-free Survival (PFS)

    Progression-free survival was calculated as the time from first dose of study drug to the first documented progression or death (from any cause) during the entire efficacy evaluation period. For participants with no progression or death, PFS was censored at the last assessment date the participant was known to be progression-free.

    Measured: From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.

  6. Maximum Observed Plasma Concentration (Cmax) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  7. Time to Maximum Plasma Concentration (Tmax) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  8. Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  9. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  10. Terminal Elimination Phase Half-Life (t½) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  11. Clearance (CL) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  12. Volume of Distribution (Vz) of Durvalumab

    Measured: Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.

  13. Maximum Observed Plasma Concentration (Cmax) of Lenalidomide

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

  14. Time to Maximum Observed Plasma Concentration (Tmax) of Lenalidomide

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

  15. Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Lenalidomide

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose

  16. Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

  17. Time to Maximum Observed Plasma Concentration (Tmax) of Ibrutinib

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.

  18. Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Ibrutinib

    Measured: Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose

  19. Change From Baseline in Soluble Programmed Cell Death Ligand-1 (sPD-L1) Concentration

    Change from baseline in sPD-L1 could not be calculated as all post-baseline samples were below the lower limit of quantification (<15.60 pg/mL).

    Measured: Baseline (Cycle 1 Day 1 predose) and Day 1 of Cycles 2 to 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study start11 May 2016
  3. Primary completion6 Mar 2019
  4. Study completion21 Aug 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Within Arms A, B, and C participants on the dose-finding part were enrolled sequentially according to a 3+3 design. All treatment arms were to be open for enrollment at study start except in the US, where Arm D was to enroll depending on the availability of treatment slots and following the completion of assessment of responses from the combination therapy arms.
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02733042
Sponsor's protocol ID
MEDI4736-NHL-001
Other IDs
2015-003516-21, 2015
Acronym
FUSION NHL 001
Status last verified
Oct 2023
First submitted
5 Apr 2016
Last updated
18 Nov 2023
Data monitoring committee
Yes

Publications

  • Casulo C, Santoro A, Cartron G, Ando K, Munoz J, Le Gouill S, Izutsu K, Rule S, Lugtenburg P, Ruan J, Arcaini L, Casadebaig ML, Fox B, Kilavuz N, Rettby N, Dell'Aringa J, Taningco L, Delarue R, Czuczman M, Witzig T. Durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia: The FUSION NHL 001 trial. Cancer Rep (Hoboken). 2023 Jan;6(1):e1662. doi: 10.1002/cnr2.1662. Epub 2022 Jul 19.

    PubMed 35852004

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Durvalumab, Lenalidomide and Rituximab in people with Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, run by Celgene at 66 sites in 7 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, France, United Kingdom, Italy, Germany and 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Mar 2020). 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?

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02733042, which also lists 1 linked publication.

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 18 Nov 2023.

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