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Lymphoma, Large B-Cell, DiffusePhase 3NCT02428751

R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma

A Phase 3 study testing Pegylated liposomal doxorubicin, Doxorubicin and Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Wenqi Jiang at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
Pegylated liposomal doxorubicin, Doxorubicin and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
7 sitesChina
Study dates
Sep 2015to May 2020
Phase
Phase 3
Are there results?
None posted in the registry

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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
  • 60~80 years old
  • Ann Arbor stage I~IV
  • ECOG physical score of 0~2
  • Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
  • Have at least one clinically measurable lesion: >= 2cm under physical examination, or >= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
Show all 14Show fewer
  • Life expectancy of >= 3 months
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin <= 2 × upper limit of normal (ULN)
  • Glomerular filtration rate (MDRD method) >= 30ml/min
  • No abnormalities in blood coagulative function
  • Generally normal bone marrow function: while blood cell >= 3,000/μL, absolute neutrophil count >= 1,500/μL, hemoglobin >= 100g/L, platelet >= 75,000/μL
  • No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
  • Left ventricular ejection fraction (LVEF) >= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
  • Cardiac function of class I-II in New York Heart Association (NYHA) classification

Who cannot join

  • Patients with indolent lymphoma
  • Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
  • Serum Epstein-Barr virus DNA >= 1,000 copies/ml
  • Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
  • Primary mediastinal B-cell lymphoma
  • Involvement of central nervous system
Show all 13Show fewer
  • Bulky disease (>= 10cm)
  • History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
  • Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
  • Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
  • History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
  • Currently enrolled in other clinical studies
  • Other conditions that the investigators consider as inappropriate for enrolling into this study

Trial locations and contacts

7 sites in 1 country.

Wen-qi Jiang, M.D. contact

86-20-87343765

wenqi_jiang@163.com

Xi-wen Bi, M.D. contact

86-13826050380

xiwen_bi@163.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510060

    Wen-yu Li, M.D., 86-13924196915

    Wen-yu Li, M.D.

    Recruiting

  • Nanfang Hospital of Southern Medical Unversity

    Guangzhou, Guangdong, 510060

    Bing Xu, M.D., 86-18688900980

    Bing Xu, M.D.

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhi-ming Li, M.D., 86-13719189172, zhimingsysucc@163.com

    Xi-wen Bi, M.D., 86-13826050380, xiwen_bi@163.com

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510060

    Huo Tan, M.D., 86-13602725539

    Huo Tan, M.D.

    Not yet recruiting

  • The Second Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Li-ping Ma, M.D., 86-13600450776

    Li-ping Ma, M.D.

    Not yet recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Xiang-yuan Wu, M.D., 86-13729813256

    Xiang-yuan Wu, M.D.

    Not yet recruiting

  • Wujing Zongdui Hospital of Guangdong Province

    Guangzhou, Guangdong, 510060

    Tao Zhou, M.D., 86-18820019866

    Tao Zhou, M.D.

    Not yet recruiting

Other trials in China

About this study

Official title: Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study

The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.

Being tested
Pegylated liposomal doxorubicin, Doxorubicin, Rituximab, Cyclophophamide, Vincristine
Keywords
Lymphoma, Large B-Cell, Diffuse, liposomal doxorubicin, doxorubicin, event-free survival
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Pegylated liposomal doxorubicinDrug

    30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

  • DoxorubicinDrug

    50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

  • RituximabDrug

    375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

  • CyclophophamideDrug

    750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

  • VincristineDrug

    1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

  • PrednisoneDrug

    100mg/d, PO on day 1-5 of each 21 day cycle

Study groups in NCT02428751
Study groupRoleWhat they receive
R-CHOPActive comparatorThis group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Receives: Drug: Doxorubicin; Drug: Rituximab; Drug: Cyclophophamide; Drug: Vincristine; Drug: Prednisone
R-CDOPExperimentalThis group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Rituximab; Drug: Cyclophophamide; Drug: Vincristine; Drug: Prednisone

What is being measured

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

  1. event-free survival (EFS)

    Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up

    Measured: two year

Secondary outcomes (3)

  1. overall response rate (ORR)

    defined as the proportion of patients whose best overall response is either complete remission (CR) or partial remission (PR), which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma

    Measured: at week 6, 12, 18, and 24 after randomization

  2. complete remission (CR) rate

    defined as the proportion of patients whose best overall response is complete remission, which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma

    Measured: at week 6, 12, 18, and 24 after randomization

  3. overall survival (OS)

    defined as time from the date of randomization to the date of death due to any cause or the most recent follow-up

    Measured: two year

Timeline

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

  1. First posted29 Apr 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMar 2020 (estimated)
  4. Study completionMay 2020 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02428751
Sponsor's protocol ID
308-2015-005
Status last verified
Nov 2015
First submitted
17 Apr 2015
Last updated
18 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Fisher RI, Gaynor ER, Dahlberg S, Oken MM, Grogan TM, Mize EM, Glick JH, Coltman CA Jr, Miller TP. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med. 1993 Apr 8;328(14):1002-6. doi: 10.1056/NEJM199304083281404.

    PubMed 7680764

  • Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.

    PubMed 15867204

  • Coiffier B, Thieblemont C, Van Den Neste E, Lepeu G, Plantier I, Castaigne S, Lefort S, Marit G, Macro M, Sebban C, Belhadj K, Bordessoule D, Ferme C, Tilly H. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010 Sep 23;116(12):2040-5. doi: 10.1182/blood-2010-03-276246. Epub 2010 Jun 14.

    PubMed 20548096

  • Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.

    PubMed 11807147

  • Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR, Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006 Jul 1;24(19):3121-7. doi: 10.1200/JCO.2005.05.1003. Epub 2006 Jun 5.

    PubMed 16754935

  • Limat S, Daguindau E, Cahn JY, Nerich V, Brion A, Perrin S, Woronoff-Lemsi MC, Deconinck E. Incidence and risk-factors of CHOP/R-CHOP-related cardiotoxicity in patients with aggressive non-Hodgkin's lymphoma. J Clin Pharm Ther. 2014 Apr;39(2):168-74. doi: 10.1111/jcpt.12124. Epub 2014 Jan 3.

    PubMed 24384030

  • Gogas H, Papadimitriou C, Kalofonos HP, Bafaloukos D, Fountzilas G, Tsavdaridis D, Anagnostopoulos A, Onyenadum A, Papakostas P, Economopoulos T, Christodoulou C, Kosmidis P, Markopoulos C. Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group. Ann Oncol. 2002 Nov;13(11):1737-42. doi: 10.1093/annonc/mdf284.

    PubMed 12419745

  • Tulpule A, Espina BM, Berman N, Buchanan LH, Smith DL, Sherrod A, Dharmapala D, Gee C, Boswell WD, Nathwani BN, Welles L, Levine AM. Phase I/II trial of nonpegylated liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in the treatment of newly diagnosed aggressive non-Hodgkin's lymphoma. Clin Lymphoma Myeloma. 2006 Jul;7(1):59-64. doi: 10.3816/CLM.2006.n.040.

    PubMed 16879771

  • O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.

    PubMed 14998846

  • Luminari S, Montanini A, Caballero D, Bologna S, Notter M, Dyer MJS, Chiappella A, Briones J, Petrini M, Barbato A, Kayitalire L, Federico M. Nonpegylated liposomal doxorubicin (MyocetTM) combination (R-COMP) chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL): results from the phase II EUR018 trial. Ann Oncol. 2010 Jul;21(7):1492-1499. doi: 10.1093/annonc/mdp544. Epub 2009 Dec 11.

    PubMed 20007997

  • Corazzelli G, Frigeri F, Arcamone M, Lucania A, Rosariavilla M, Morelli E, Amore A, Capobianco G, Caronna A, Becchimanzi C, Volzone F, Marcacci G, Russo F, De Filippi R, Mastrullo L, Pinto A. Biweekly rituximab, cyclophosphamide, vincristine, non-pegylated liposome-encapsulated doxorubicin and prednisone (R-COMP-14) in elderly patients with poor-risk diffuse large B-cell lymphoma and moderate to high 'life threat' impact cardiopathy. Br J Haematol. 2011 Sep;154(5):579-89. doi: 10.1111/j.1365-2141.2011.08786.x. Epub 2011 Jun 28.

    PubMed 21707585

  • Zaja F, Tomadini V, Zaccaria A, Lenoci M, Battista M, Molinari AL, Fabbri A, Battista R, Cabras MG, Gallamini A, Fanin R. CHOP-rituximab with pegylated liposomal doxorubicin for the treatment of elderly patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2006 Oct;47(10):2174-80. doi: 10.1080/10428190600799946.

    PubMed 17071492

  • Rigacci L, Mappa S, Nassi L, Alterini R, Carrai V, Bernardi F, Bosi A. Liposome-encapsulated doxorubicin in combination with cyclophosphamide, vincristine, prednisone and rituximab in patients with lymphoma and concurrent cardiac diseases or pre-treated with anthracyclines. Hematol Oncol. 2007 Dec;25(4):198-203. doi: 10.1002/hon.827.

    PubMed 17654614

  • Visani G, Guiducci B, D'Adamo F, Mele A, Nicolini G, Leopardi G, Sparaventi G, Barulli S, Malerba L, Isidori A, Malagola M, Piccaluga PP. Cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) plus rituximab is effective and well tolerated in poor performance status elderly patients with non-Hodgkin's lymphoma. Leuk Lymphoma. 2005 Mar;46(3):477-9. doi: 10.1080/10428190400013688. No abstract available.

    PubMed 15621843

  • Heintel D, Skrabs C, Hauswirth A, Eigenberger K, Einberger C, Raderer M, Sperr WR, Knobl P, Mullauer L, Uffmann M, Dieckmann K, Gaiger A, Jager U. Nonpegylated liposomal doxorubicin is highly active in patients with B and T/NK cell lymphomas with cardiac comorbidity or higher age. Ann Hematol. 2010 Feb;89(2):163-9. doi: 10.1007/s00277-009-0796-5. Epub 2009 Jul 28.

    PubMed 19636553

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated liposomal doxorubicin, Doxorubicin and Rituximab in people with Lymphoma, Large B-Cell, Diffuse, run by Wenqi Jiang at 7 sites in China.

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 14 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wen-qi Jiang, M.D. (86-20-87343765, wenqi_jiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

event-free survival (EFS) (time frame: two year). 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 NCT02428751, which also lists 16 linked publications.

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 2015.

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