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T-LGL LeukemiaPhase 2/3NCT04453345

TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL

A Phase 2/3 study testing thalidomide + prednisone + methotrexate in people with T-LGL Leukemia and Clpd-Nk, run by Institute of Hematology & Blood Diseases Hospital, China at 9 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Large granular lymphocytic leukemia (LGLL) is a lymphoproliferative disease, with LGL infiltration in peripheral blood and bone marrow, hepatosplenomegaly, and cytopenia. Both T-LGLL and CLPD-NK are indolent disease and share similar biology and clinical course, and treated under the same strategy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-LGL Leukemia, Clpd-Nk
What is being tested?
thalidomide + prednisone + methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
9 sitesChina
Study dates
20 May 2013to 20 May 2025
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The gender of the patient is not limited, and the age is ≥18 years old;
  • Must meet diagnostic criteria of T-LGLL or CLPD-NK according to WHO 2016 version;
  • The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate.
  • With LGLL treatment indications, it mainly includes (meets at least one of the following conditions):
  • ANC <0.5 × 10^9 / L
  • HGB <100g / L or need red blood cell infusion to maintain
Show all 13Show fewer
  • PLT <50 × 10^9 / L
  • Combining autoimmune diseases that require treatment
  • symptomatic splenomegaly
  • Severe B symptoms
  • Pulmonary hypertension.
  • ECOG performance status score is 0-2;
  • The patient's expected survival time is ≥ 6 months.

Who cannot join

  • Unable to understand or follow the research procedure;
  • Co-occurrent malignant tumors that has to be treated or course the symptom;
  • Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A;
  • ALAT / ASAT or alkaline phosphatase> 3 times the normal value;
  • Creatinine clearance <60ml / min;
  • Serological evidence of active infection of HIV, hepatitis C or hepatitis B;
Show all 9Show fewer
  • Ineffective contraception;
  • Positive pregnancy test;
  • Pregnant women.

Trial locations and contacts

9 sites in 1 country.

Shuo Chen contact

+86022-23909095

chenshuo@ihcams.ac.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • The First Affiliated Hospital of Jilin University

    Ch’ang-ch’un, Jilin, 130000

    Fengyan Jin, Dr, 13844989638

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Hongling Peng, Dr, 17612205739

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Fei Li, Dr, 18920526571

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Qiaochuan Li, Dr, 13768411929

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300020

    Shuhua Yi, Dr., 86-022-23909106, yishuhua@ihcams.ac.cn

    Lugui Qiu, Dr., 86-022-23909286, qiulg@ihcams.ac.cn

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300020

    Qi Deng, Dr, 13516224562

    Recruiting

  • Tongji hopital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Jianfeng Zhou, Dr, 13971600192

    Recruiting

  • Xijing Hospital, Air Force Military Medical University

    Xi’an, Shanxi, 710000

    Xiequn Chen, Dr, 13991907320

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Keshu Zhou, Dr, 13674902391

    Recruiting

Other trials in China

About this study

Official title: The Efficacy of Thalidomide Plus Prednisone and Methotrexate for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Multicenter Clinical Trial From China

Large granular lymphocytic leukemia (LGLL) is a lymphoproliferative disease, with LGL infiltration in peripheral blood and bone marrow, hepatosplenomegaly, and cytopenia. Both T-LGLL and CLPD-NK are indolent disease and share similar biology and clinical course, and treated under the same strategy. So the investigators put them together as LGLL. The investigators used TPM regimen (thalidomide + prednison + methotrexate ) to treat LGLL since 2013, and 18/20 patients (90%) obtained clinical response, including 80% complete response. Adverse events (AE) of grade 3 and above are rare and safe. Therefore, the investigators designed this multicenter clinical trial to validate the efficacy of the TPM regimen in symptomatic T-LGLL and CLPD-NK.

Read the detailed description

Because LGLL has continuously activated cytotoxic T lymphocytes, immunosuppressive therapy is the standard first-line therapy for T-LGLL and CLPD-NK. Previous studies showed that the overall response rate (ORR) of first-line oral immunosuppressants ranged from 21% to 85% (median: 50%). Both methotrexate and cyclosporine A are LGLL first-line treatment options, but the CR rate of methotrexate is only 21%, while the CR rate of CsA is less than 5%. There is insufficient evidence for the treatment of LGLL with prednisone and other glucocorticoids, but it can reduce RA-related inflammation and increase granulocyte levels. The TPM regimen was designed by the investigators. A pilot prospect observation showed that 18/20 (90%) patients obtained response, including 80% CR. This study is a prospective multiple center clinical trail to evaluate the efficacy of TPM regimen in the treatment of symptomatic LGLL. Eligible patients choose the initial treatment plan: thalidomide 50-100mg qn+ prednisone 0.5-1mg / kg qod +methotrexate 10mg / m2 / week. Four months is one course. Maximum three courses will be given if there is a response and thalidomide maintenance will be for another year.

Being tested
thalidomide + prednisone + methotrexate
Keywords
Large granular lymphocyte leukemia, thalidomide, methotrexate
Medical subject headings
Leukemia, Large Granular Lymphocytic

What participants receive

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

  • thalidomide + prednisone + methotrexateDrug

    Also called TPM regimen

    thalidomide 50-100mg daily at bedtime + prednisone 0.5mg/kg qod to 1mg/kg qd + methotrexate 10mg/m2 per week. 4 months one cycle, up to 3 cycles. After get partial remission, thalidomide maintenance will continue up to 2 years.

Study groups in NCT04453345
Study groupRoleWhat they receive
TPM regimenExperimentalthalidomide 50-100mg daily at bedtime + prednisone 0.5mg/kg qod to 1mg/kg qd + methotrexate 10mg/m2 per week. 4 months one cycle, up to 3 cycles. After get partial remission, thalidomide maintenance will continue up to 2 years.
Receives: Drug: thalidomide + prednisone + methotrexate

What is being measured

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

  1. Complete response (CR) rate of TPM regimen

    Hb> 120g / L，platelet> 100×109 / L，ANC > 1.5×109 / L），ALC< 4×109 / L，peripheral LGL in normal（< 0.5×109 / L）

    Measured: From date of TPM treatment until the date of complete response, assessed up to 100 months

Secondary outcomes (4)

  1. Overall response (PR)

    improvement in blood counts (ANC > 0.5 × 10^9/L; HGB increased by >1 g/dL; PLT > 50 × 10^9/L), and the absence of required transfusions.

    Measured: From date of TPM treatment until the date of at least partial response, assessed up to 100 months

  2. Progression-free survival (PFS)

    the length of time during and after the treatment of LGLL

    Measured: From date of TPM treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  3. Duration of response (DoR)

    the time from response to progression/death (P/D)

    Measured: From date of getting response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  4. overall survival

    the length of the patients survival time

    Measured: From date of TPM treatment until the date of death from any cause, assessed up to 180 months

Timeline

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

  1. First posted1 Jul 2020
  2. Study start20 May 2013
  3. Primary completion20 May 2023 (estimated)
  4. Study completion20 May 2025 (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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
TPM treatment plan: thalidomide 50-100mg qn + prednisone 0.5-1mg / kg qod +methotrexate 10mg / m2 / week.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453345
Sponsor's protocol ID
IIT2020003-EC-1
Status last verified
Jun 2020
First submitted
24 Jun 2020
Last updated
1 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dinmohamed AG, Brink M, Visser O, Jongen-Lavrencic M. Population-based analyses among 184 patients diagnosed with large granular lymphocyte leukemia in the Netherlands between 2001 and 2013. Leukemia. 2016 Jun;30(6):1449-51. doi: 10.1038/leu.2016.68. Epub 2016 Apr 8. No abstract available.

    PubMed 27055870

  • Matutes E. Large granular lymphocytic leukemia. Current diagnostic and therapeutic approaches and novel treatment options. Expert Rev Hematol. 2017 Mar;10(3):251-258. doi: 10.1080/17474086.2017.1284585. Epub 2017 Jan 29.

    PubMed 28128670

  • Moignet A, Lamy T. Latest Advances in the Diagnosis and Treatment of Large Granular Lymphocytic Leukemia. Am Soc Clin Oncol Educ Book. 2018 May 23;38:616-625. doi: 10.1200/EDBK_200689.

    PubMed 30231346

  • Zambello R, Teramo A, Gattazzo C, Semenzato G. Are T-LGL Leukemia and NK-Chronic Lymphoproliferative Disorder really two distinct diseases? Transl Med UniSa. 2014 Feb 4;8:4-11. eCollection 2014 Jan.

    PubMed 24778993

  • Cheon H, Dziewulska KH, Moosic KB, Olson KC, Gru AA, Feith DJ, Loughran TP Jr. Advances in the Diagnosis and Treatment of Large Granular Lymphocytic Leukemia. Curr Hematol Malig Rep. 2020 Apr;15(2):103-112. doi: 10.1007/s11899-020-00565-6.

    PubMed 32062772

  • Lamy T, Moignet A, Loughran TP Jr. LGL leukemia: from pathogenesis to treatment. Blood. 2017 Mar 2;129(9):1082-1094. doi: 10.1182/blood-2016-08-692590. Epub 2017 Jan 23.

    PubMed 28115367

  • Yu Y, Li Y, Cui R, Yan Y, Li F, Chen Y, Wang T, Hu X, Feng Y, Yu T, Huang Y, Sun J, Lyu R, Xiong W, Wang Q, Liu W, An G, Sui W, Xu Y, Huang W, Zou D, Wang H, Xiao Z, Wang J, Qiu L, Yi S. Thalidomide-based regimen shows promising efficacy in large granular lymphocytic leukemia: a multicenter phase II study. Signal Transduct Target Ther. 2025 Mar 12;10(1):85. doi: 10.1038/s41392-025-02164-4.

    PubMed 40069155

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing thalidomide + prednisone + methotrexate in people with T-LGL Leukemia and Clpd-Nk, run by Institute of Hematology & Blood Diseases Hospital, China at 9 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 13 inclusion and 9 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 combined 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.

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 Shuo Chen (+86022-23909095, chenshuo@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate of TPM regimen (time frame: From date of TPM treatment until the date of complete response, assessed up to 100 months). 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 NCT04453345, which also lists 7 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 1 Jul 2020.

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