Enteropathy Associated T Cell LymphomaPhase 2GOALNCT06701344
Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients
A Phase 2 study testing Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone) and Golidocitinib in people with Enteropathy Associated T Cell Lymphoma, run by Ruijin Hospital.
Trial summary
The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Enteropathy Associated T Cell Lymphoma
- What is being tested?
- Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone) and Golidocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2024to 4 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old, both male and female participants are eligible; Histopathologically confirmed, untreated intestinal T-cell lymphoma, including: enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, intestinal T-cell lymphoma not otherwise specified (NOS), and other subtypes of intestinal T-cell lymphoma deemed appropriate for inclusion by the investigator; Expected survival of ≥12 weeks, with cardiac, pulmonary, hepatic, and renal functions assessed by the investigator as adequate for the proposed treatment regimen; Female participants of childbearing potential and male participants with partners of childbearing potential must agree to and adhere to effective contraceptive measures during the treatment period and for 180 days after the last dose of the study drug; Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up assessments.
Who cannot join
- Involvement of the central nervous system (CNS); Receipt of any antitumor treatment (including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or investigational drugs) within 28 days prior to the first dose or within five half-lives of the antitumor drug, whichever is shorter; Major surgery within 28 days prior to the first dose or planned surgery during the study period; Presence of other uncontrolled malignancies. Early-stage cancers that have been treated with curative intent, such as in situ lung cancer, non-melanoma skin cancers (basal or squamous cell carcinoma), or cervical carcinoma in situ, may be excluded at the investigator's discretion; History of allogeneic hematopoietic stem cell transplantation;
- Any of the following treatment histories:
- Current use (or inability to discontinue use) of strong CYP3A inducers (within at least 3 weeks) or strong inhibitors (within at least 1 week) prior to the first dose;
- Prior use of JAK or STAT3 inhibitors;
- Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue these medications within 1 week prior to the first dose);
- Vaccination with live vaccines within 28 days prior to the first dose (except for attenuated influenza vaccines);
Show all 19Show fewer
- Active infections, including:
- Known active or latent tuberculosis, including positive tuberculin skin tests (PPD), or findings of active or latent tuberculosis on chest X-ray/CT scans (positive skin test defined as an induration diameter >10 mm or according to local clinical standards);
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS);
- Active chronic hepatitis B or hepatitis C infections, defined as hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positivity. Patients with HBsAg-negative but hepatitis B core antibody (HBcAb)-positive results must undergo hepatitis B virus DNA testing, and those with HBV DNA ≥1000 IU/mL will be excluded;
- Active infections requiring treatment within 14 days, including pneumonia;
- Poorly controlled cardiac symptoms or diseases, such as:
- NYHA class > II heart failure;
- Unstable angina;
- Myocardial infarction within 1 year;
- Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Left ventricular ejection fraction (LVEF) ≤ 50%;
- Abnormal laboratory test results during screening (unless attributed to lymphoma):
- Neutrophils <1.5×10⁹/L; Platelets <75×10⁹/L; ALT or AST >2× upper limit of normal (ULN), alkaline phosphatase (AKP), or bilirubin >1.5× ULN; Creatinine >1.5× ULN; History of interstitial lung disease, excluding asymptomatic, radiation-induced interstitial lung disease; Unresolved drug-related adverse events ≥ grade 2 (CTCAE) prior to the first dose, except for alopecia; Hypersensitivity to golisitinib, capsule excipients, or chemically related compounds; Pregnancy, lactation, or unwillingness to use contraception for female participants of childbearing potential; Known history of substance or drug abuse; Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase study participation risk, interfere with study outcomes, or, in the investigator's opinion, make the patient unsuitable for the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of the Combination Therapy of Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients
The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.
- Conditions
- Enteropathy Associated T Cell Lymphoma
- Being tested
- Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone), Golidocitinib
- Keywords
- Enteropathy-Associated T-Cell Lymphoma, Golidocitinib
- Medical subject headings
- Enteropathy-Associated T-Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)Drug
Induction Treatment:
Golidocitinib:150mg QD Cyclophosphamide:750mg/m2，d1 vincristine:1.4mg/m2，d1(max 2mg) doxorubicin:50mg/m2，d1 Prednisone:60mg/m2 (max 100mg)，d1-d5 Every 21 days
GolidocitinibDrug
Maintenance Treatment:
Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT.
| Study group | Role | What they receive |
|---|---|---|
| Go-CHOP | Experimental | Golidocitinib 150mg qd plus Standard CHOP regimen Receives: Drug: Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone); Drug: Golidocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of Cycle 6 (each cycle is 21days)
Secondary outcomes (5)
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Objective Response Rate
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: At the end of Cycle 6 (each cycle is 21days)
Duration of Response
Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Baseline up to data cut-off(up to approximately 3 years)
Adverse Events
Adverse Events are assessed based on CTCAE v5.0
Measured: Baseline up to data cut-off(up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start4 Dec 2024 (estimated)
- Primary completion4 May 2026 (estimated)
- Study completion4 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Enteropathy Associated T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701344
- Sponsor's protocol ID
- GOAL
- Acronym
- GOAL
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao C, Feng J, Gu H, Tang H, Xu L, Dong H, Dong B, Shu M, Bai Q, Liang R, Zhang T, Yang L, Wang Z, Chen X, Gao G. Distribution of lymphoid neoplasms in Northwest China: Analysis of 3244 cases according to WHO classification in a single institution. Ann Diagn Pathol. 2018 Jun;34:60-65. doi: 10.1016/j.anndiagpath.2017.05.005. Epub 2017 May 12.
PubMed 29661730Greenplate A, Wang K, Tripathi RM, Palma N, Ali SM, Stephens PJ, Miller VA, Shyr Y, Guo Y, Reddy NM, Kozhaya L, Unutmaz D, Chen X, Irish JM, Dave UP. Genomic Profiling of T-Cell Neoplasms Reveals Frequent JAK1 and JAK3 Mutations With Clonal Evasion From Targeted Therapies. JCO Precis Oncol. 2018;2018:PO.17.00019. doi: 10.1200/PO.17.00019. Epub 2018 Feb 13.
PubMed 30079384Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.
PubMed 18626005d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Osterborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Ostenstad B, Fagerli UM, Gadeberg OV, Sundstrom C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. doi: 10.1200/JCO.2011.40.2719. Epub 2012 Jul 30.
PubMed 22851556Malamut G, Chandesris O, Verkarre V, Meresse B, Callens C, Macintyre E, Bouhnik Y, Gornet JM, Allez M, Jian R, Berger A, Chatellier G, Brousse N, Hermine O, Cerf-Bensussan N, Cellier C. Enteropathy associated T cell lymphoma in celiac disease: a large retrospective study. Dig Liver Dis. 2013 May;45(5):377-84. doi: 10.1016/j.dld.2012.12.001. Epub 2013 Jan 10.
PubMed 23313469Sharaiha RZ, Lebwohl B, Reimers L, Bhagat G, Green PH, Neugut AI. Increasing incidence of enteropathy-associated T-cell lymphoma in the United States, 1973-2008. Cancer. 2012 Aug 1;118(15):3786-92. doi: 10.1002/cncr.26700. Epub 2011 Dec 13.
PubMed 22169928West J, Jepsen P, Card TR, Crooks CJ, Bishton M. Incidence and Survival in Patients With Enteropathy-associated T-Cell Lymphoma: Nationwide Registry Studies From England and Denmark. Gastroenterology. 2023 Oct;165(4):1064-1066.e3. doi: 10.1053/j.gastro.2023.06.003. Epub 2023 Jun 9. No abstract available.
PubMed 37301328Verbeek WH, Van De Water JM, Al-Toma A, Oudejans JJ, Mulder CJ, Coupe VM. Incidence of enteropathy--associated T-cell lymphoma: a nation-wide study of a population-based registry in The Netherlands. Scand J Gastroenterol. 2008;43(11):1322-8. doi: 10.1080/00365520802240222.
PubMed 18618372Al-Toma A, Goerres MS, Meijer JW, Pena AS, Crusius JB, Mulder CJ. Human leukocyte antigen-DQ2 homozygosity and the development of refractory celiac disease and enteropathy-associated T-cell lymphoma. Clin Gastroenterol Hepatol. 2006 Mar;4(3):315-9. doi: 10.1016/j.cgh.2005.12.011.
PubMed 16527694Sieniawski M, Angamuthu N, Boyd K, Chasty R, Davies J, Forsyth P, Jack F, Lyons S, Mounter P, Revell P, Proctor SJ, Lennard AL. Evaluation of enteropathy-associated T-cell lymphoma comparing standard therapies with a novel regimen including autologous stem cell transplantation. Blood. 2010 May 6;115(18):3664-70. doi: 10.1182/blood-2009-07-231324. Epub 2010 Mar 2.
PubMed 20197551Gale J, Simmonds PD, Mead GM, Sweetenham JW, Wright DH. Enteropathy-type intestinal T-cell lymphoma: clinical features and treatment of 31 patients in a single center. J Clin Oncol. 2000 Feb;18(4):795-803. doi: 10.1200/JCO.2000.18.4.795.
PubMed 10673521Delabie J, Holte H, Vose JM, Ullrich F, Jaffe ES, Savage KJ, Connors JM, Rimsza L, Harris NL, Muller-Hermelink K, Rudiger T, Coiffier B, Gascoyne RD, Berger F, Tobinai K, Au WY, Liang R, Montserrat E, Hochberg EP, Pileri S, Federico M, Nathwani B, Armitage JO, Weisenburger DD. Enteropathy-associated T-cell lymphoma: clinical and histological findings from the international peripheral T-cell lymphoma project. Blood. 2011 Jul 7;118(1):148-55. doi: 10.1182/blood-2011-02-335216. Epub 2011 May 12.
PubMed 21566094
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of the Combination Therapy of Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT06701344
- Acronym / sponsor ID
- GOAL / GOAL
- Conditions
- Enteropathy Associated T Cell Lymphoma
- Keywords
- Enteropathy-Associated T-Cell Lymphoma, Golidocitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (estimated)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 4 Dec 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Go-CHOP | Experimental | Drug: Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone), Drug: GolidocitinibGolidocitinib 150mg qd plus Standard CHOP regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18-75 years old, both male and female participants are eligible; Histopathologically confirmed, untreated intestinal T-cell lymphoma, including: enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, intestinal T-cell lymphoma not otherwise specified (NOS), and other subtypes of intestinal T-cell lymphoma deemed appropriate for inclusion by the investigator; Expected survival of ≥12 weeks, with cardiac, pulmonary, hepatic, and renal functions assessed by the investigator as adequate for the proposed treatment regimen; Female participants of childbearing potential and male participants with partners of childbearing potential must agree to and adhere to effective contraceptive measures during the treatment period and for 180 days after the last dose of the study drug; Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up assessments.
Key exclusion criteria (19 listed)
- Involvement of the central nervous system (CNS); Receipt of any antitumor treatment (including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or investigational drugs) within 28 days prior to the first dose or within five half-lives of the antitumor drug, whichever is shorter; Major surgery within 28 days prior to the first dose or planned surgery during the study period; Presence of other uncontrolled malignancies. Early-stage cancers that have been treated with curative intent, such as in situ lung cancer, non-melanoma skin cancers (basal or squamous cell carcinoma), or cervical carcinoma in situ, may be excluded at the investigator's discretion; History of allogeneic hematopoietic stem cell transplantation;
- Current use (or inability to discontinue use) of strong CYP3A inducers (within at least 3 weeks) or strong inhibitors (within at least 1 week) prior to the first dose;
- Prior use of JAK or STAT3 inhibitors;
- Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue these medications within 1 week prior to the first dose);
- Vaccination with live vaccines within 28 days prior to the first dose (except for attenuated influenza vaccines);
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 |
|---|---|---|
| Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)Induction Treatment: Golidocitinib:150mg QD Cyclophosphamide:750mg/m2，d1 vincristine:1.4mg/m2，d1(max 2mg) doxorubicin:50mg/m2，d1 Prednisone:60mg/m2 (max 100mg)，d1-d5 Every 21 days | Drug | Go-CHOP |
| GolidocitinibMaintenance Treatment: Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT. | Drug | Go-CHOP |
Primary outcome
Complete Response Rate
Time frame: At the end of Cycle 6 (each cycle is 21days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
5 secondary outcomes
Progression-free survival
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Objective Response Rate
Time frame: At the end of Cycle 6 (each cycle is 21days)
Duration of Response
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Adverse Events
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 29661730Cao C, Feng J, Gu H, Tang H, Xu L, Dong H, Dong B, Shu M, Bai Q, Liang R, Zhang T, Yang L, Wang Z, Chen X, Gao G. Distribution of lymphoid neoplasms in Northwest China: Analysis of 3244 cases according to WHO classification in a single institution. Ann Diagn Pathol. 2018 Jun;34:60-65. doi: 10.1016/j.anndiagpath.2017.05.005. Epub 2017 May 12.
- Background: PubMed 30079384Greenplate A, Wang K, Tripathi RM, Palma N, Ali SM, Stephens PJ, Miller VA, Shyr Y, Guo Y, Reddy NM, Kozhaya L, Unutmaz D, Chen X, Irish JM, Dave UP. Genomic Profiling of T-Cell Neoplasms Reveals Frequent JAK1 and JAK3 Mutations With Clonal Evasion From Targeted Therapies. JCO Precis Oncol. 2018;2018:PO.17.00019. doi: 10.1200/PO.17.00019. Epub 2018 Feb 13.
- Background: PubMed 18626005Vose J, Armitage J, Weisenburger D; International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008 Sep 1;26(25):4124-30. doi: 10.1200/JCO.2008.16.4558. Epub 2008 Jul 14.
- Background: PubMed 22851556d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Osterborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Ostenstad B, Fagerli UM, Gadeberg OV, Sundstrom C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. doi: 10.1200/JCO.2011.40.2719. Epub 2012 Jul 30.
- Background: PubMed 23313469Malamut G, Chandesris O, Verkarre V, Meresse B, Callens C, Macintyre E, Bouhnik Y, Gornet JM, Allez M, Jian R, Berger A, Chatellier G, Brousse N, Hermine O, Cerf-Bensussan N, Cellier C. Enteropathy associated T cell lymphoma in celiac disease: a large retrospective study. Dig Liver Dis. 2013 May;45(5):377-84. doi: 10.1016/j.dld.2012.12.001. Epub 2013 Jan 10.
- Background: PubMed 22169928Sharaiha RZ, Lebwohl B, Reimers L, Bhagat G, Green PH, Neugut AI. Increasing incidence of enteropathy-associated T-cell lymphoma in the United States, 1973-2008. Cancer. 2012 Aug 1;118(15):3786-92. doi: 10.1002/cncr.26700. Epub 2011 Dec 13.
- Background: PubMed 37301328West J, Jepsen P, Card TR, Crooks CJ, Bishton M. Incidence and Survival in Patients With Enteropathy-associated T-Cell Lymphoma: Nationwide Registry Studies From England and Denmark. Gastroenterology. 2023 Oct;165(4):1064-1066.e3. doi: 10.1053/j.gastro.2023.06.003. Epub 2023 Jun 9. No abstract available.
- Background: PubMed 18618372Verbeek WH, Van De Water JM, Al-Toma A, Oudejans JJ, Mulder CJ, Coupe VM. Incidence of enteropathy--associated T-cell lymphoma: a nation-wide study of a population-based registry in The Netherlands. Scand J Gastroenterol. 2008;43(11):1322-8. doi: 10.1080/00365520802240222.
- Background: PubMed 16527694Al-Toma A, Goerres MS, Meijer JW, Pena AS, Crusius JB, Mulder CJ. Human leukocyte antigen-DQ2 homozygosity and the development of refractory celiac disease and enteropathy-associated T-cell lymphoma. Clin Gastroenterol Hepatol. 2006 Mar;4(3):315-9. doi: 10.1016/j.cgh.2005.12.011.
- Background: PubMed 20197551Sieniawski M, Angamuthu N, Boyd K, Chasty R, Davies J, Forsyth P, Jack F, Lyons S, Mounter P, Revell P, Proctor SJ, Lennard AL. Evaluation of enteropathy-associated T-cell lymphoma comparing standard therapies with a novel regimen including autologous stem cell transplantation. Blood. 2010 May 6;115(18):3664-70. doi: 10.1182/blood-2009-07-231324. Epub 2010 Mar 2.
- Background: PubMed 10673521Gale J, Simmonds PD, Mead GM, Sweetenham JW, Wright DH. Enteropathy-type intestinal T-cell lymphoma: clinical features and treatment of 31 patients in a single center. J Clin Oncol. 2000 Feb;18(4):795-803. doi: 10.1200/JCO.2000.18.4.795.
- Background: PubMed 21566094Delabie J, Holte H, Vose JM, Ullrich F, Jaffe ES, Savage KJ, Connors JM, Rimsza L, Harris NL, Muller-Hermelink K, Rudiger T, Coiffier B, Gascoyne RD, Berger F, Tobinai K, Au WY, Liang R, Montserrat E, Hochberg EP, Pileri S, Federico M, Nathwani B, Armitage JO, Weisenburger DD. Enteropathy-associated T-cell lymphoma: clinical and histological findings from the international peripheral T-cell lymphoma project. Blood. 2011 Jul 7;118(1):148-55. doi: 10.1182/blood-2011-02-335216. Epub 2011 May 12.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone) and Golidocitinib in people with Enteropathy Associated T Cell Lymphoma, run by Ruijin Hospital.
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 1 inclusion and 19 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Wang (+86 02164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: At the end of Cycle 6 (each cycle is 21days)). 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 NCT06701344, which also lists 12 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 22 Nov 2024.