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T-lymphoblastic LeukemiaPhase 3NCT06434467

The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma

A Phase 3 study testing Nelarabine injection in people with T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-arm, open-label, multicenter, phase III clinical study that aims to evaluate the efficacy and safety of Nelarabine injection in the treatment of refractory or recurrent T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) in both children and adults. Read more about this study

Who is it for?
Ages 1 year to 65 years
What is being tested?
Nelarabine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
30 sitesChina
Study dates
May 2024to May 2026
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 1 year to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The subjects voluntarily joined this study, signed an informed consent form, and had good compliance;
  • Age: ≥ 1 year old and ≤ 65 years old (if the child has no reading ability, the child's immediate family/guardian can fully read the informed consent form, sign and witness the informed consent process); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-2 points; Expected survival period exceeds 3 months;
  • Subject population:
  • According to the revised classification criteria for myeloid tumors and acute leukemia in 2016, morphology, immunology, cytogenetic and molecular (MICM) classification and/or pathological and imaging diagnosis confirmed by local laboratories as T-ALL or T-LBL stage II-IV;
  • Philadelphia chromosome negative (Ph -);
  • Difficult to treat or disease recurrence status;
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  • Previously received two chemotherapy regimens without response, or experienced recurrence after treatment.
  • The main organ functions well and meets the following standards:
  • Biochemical examination must meet the following standards:
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN) (if T-ALL/T-LBL affects the liver, total bilirubin ≤ 3 times the upper limit of normal value); Alanine transferase (ALT) and aspartate transferase (AST) ≤ 3 × ULN (if T-ALL/T-LBL affects the liver, ALT and/or AST ≤ 5 × ULN);
  • Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate estimated based on Cockcroft Gault glomerular filtration formula ≥ 50 mL/min.
  • The coagulation function test needs to meet the following standards: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤ 1.5 x ULN (without receiving anticoagulant treatment).
  • Before starting to use the investigational drug, all non hematological toxicity (except for hair loss and fatigue) of previous anti leukemia treatments must have been restored to level 1 or baseline levels ((NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0));
  • Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; Male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.

Who cannot join

  • Previous treatment:
  • Within 3 weeks prior to the first medication, chemotherapy (including intrathecal injection, excluding ALL/LBL maintenance therapy) was received. Within 12 weeks prior to the first medication, radiation therapy (brain spine, pelvis, and other radiation areas exceeding 25% of the total bone marrow volume), immune checkpoint inhibitors, Chimeric Antigen Receptor T-Cell (CAR-T) Therapy were received. Other small molecule anti-tumor treatments received before the first medication (washout period calculated from the end of the last treatment) were within 5 half-lives;
  • Within 7 days prior to the first administration, receive ≥ 5 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Within 28 days prior to the first administration, receive ≥ 14 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Single dose prevention or treatment of airway stenosis is allowed to be used; Note: If the patient's white blood cell (WBC) is ≥ 30 × 10^9/L, or if the liver, spleen, or lymph nodes are significantly enlarged; Patients with tumor lysis characteristics (biochemical tests, etc.) may undergo pre-treatment, and the use of prednisone/dexamethasone ± cyclophosphamide during the pre-treatment period is allowed to prevent tumor lysis syndrome;
  • Vaccination received within 4 weeks prior to the first medication, or planned vaccination during the study period;
  • Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first medication use;
  • According to the researcher's judgment, there are individuals with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or individuals who are deemed unsuitable for enrollment due to other reasons.
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  • Concomitant diseases and medical history:
  • Has experienced or currently suffers from other malignant tumors within 3 years prior to the first medication use. The following two situations can be included in the study: achieving disease-free survival (DFS) for 5 consecutive years for other malignant tumors treated with a single surgery; Cured cervical cancer in situ, thyroid cancer, non melanoma skin cancer, and superficial bladder tumors [Ta (non invasive tumor), Ti (carcinoma in situ), and T1 (tumor infiltrating basement membrane)];
  • Unresolved neurotoxicity of ≥ CTC AE II grade due to any previous treatment;
  • Within 28 days prior to the start of the research treatment, significant surgical treatment, open biopsy, and obvious traumatic injury were received;
  • Within 3 months prior to the first medication, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
  • Within 6 months prior to the first medication, the patient had ≥ grade 2 myocardial ischemia or infarction, arrhythmia (QTcF>450ms in males and>470ms in females), ≥ grade 2 congestive heart failure (NYHA classification), and left ventricular ejection fraction (LVEF) assessed by echocardiography<50%.
  • Existence of active infection (≥ CTC AE level 2 infection);
  • Active hepatitis *; Hepatitis B reference: hepatitis B virus (HBV) DNA detection value ≥ upper limit of normal value; Hepatitis C reference: hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
  • Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Have a history of epilepsy;
  • Have a history of Down syndrome;
  • Merge central nervous system leukemia/lymphoma.
  • The patient plans to receive chest radiation therapy.

Trial locations and contacts

30 sites in 1 country.

Jun Ma, Doctor contact

13304518000

majun0322@126.com

Yizhuo Zhang, Doctor contact

18819241079

zhangyzh@sysucc.org.cn

30 sites in 1 country

China30 sites

  • Aerospace Medical Center

    Beijing, Beijing Municipality, 100049

    Jingbo Wang, Doctor, 13693587668, dpwangjingbo@vip.sina.com

  • Beijing Tongren Hospital,CMU

    Beijing, Beijing Municipality, 100730

    Dongsheng Huang, Doctor, 13601113102, hds5180@sina.com

  • The First Hospital Of Jilin University

    Changchun, Jilin, 130000

    Yehui Tan, Doctor, 15804302605, 276769165@qq.com

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Mincui Zheng, Master, 13908467333, 13908467333@163.com

  • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Xiaobing Huang, Doctor, 18981838236, huangxiaobing@med.uestc.edu.cn

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Jie Yu, Doctor, 13983762652, 1808106657@qq.com

  • The Second Affiliated Hospital of Army Military Medical University

    Chongqing, Chongqing Municipality, 400037

  • Sun Yat-sen University Cancer Prevention Center

    Guangzhou, Guangdong, 510062

    Yizhuo Zhang, Doctor, 18819241079, zhangyzh@sysucc.org.cn

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Xiaojun Xu, Doctor, 13858067554, xuxiaojun@zju.edu.cn

  • Affiliated cancer hospital of harbin medical university

    Harbin, Heilongjiang, 150001

    Aichun Liu, Doctor, 13633611958, aichun2002@hotmail.com

  • Institute of Hematology & Oncology, Harbin First Hospital

    Harbin, Heilongjiang, 150010

    Jun Ma, Doctor, 13304518000, majun0322@126.com

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Xiaoyu Zhu, Doctor, 15255456091, xiaoyuz@ustc.edu.cn

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Mingxia Shi, Doctor, 13888060581, Shmxia2002@sina.com

  • The first hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Zijian Li, Doctor, 18993115461, ldyy_lizj@lzu.edu.cn

  • Nanjing childrens Hospital

    Nanjing, Jiangsu, 210008

    Yongjun Fang, Doctor, 18951769586, fyj322@189.cn

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

    Yu Zhu, Doctor, 13851435363, zhuyu@jsph.org.cn

  • Cancer Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

    Hong Cen, Doctor, 13507711671, cen_hong@163.com

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Yunyan He, Doctor, 13607868275, yunyanhe@aliyun.com

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Xiaoqin Wang, Doctor, 13621851543, wangxiaoqin@shmu.edu.cn

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

    Xiaowen Zhai, Doctor, 18017590808, zhaixiaowendy@163.com

  • The second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50004

    Jingyu Zhang, Doctor, 18032227288, zhangjy69@163.com

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300202

    Yafei Wang, Doctor, 18622221250, Drwang2005@163.com

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Xinhong Guo, Doctor, 15292898288, guoxinhong222@sina.cn

  • Weihai Municipal Hospital

    Weihai, Shandong, 264200

    Jie Yu, Doctor, 13869058479, yujiejessica@126.com

  • Tongji Medical College of HUST

    Wuhan, Hubei, 430030

    Aiguo Liu, Doctor, 13807196944, drliuaiguo@163.com

  • Shanxi Provincial People's Hospital

    Xi’an, Shanxi, 710068

    Yi Wang, Doctor, 13571936193, 13571936193@163.com

  • Xingtai People's Hospital

    Xingtai, Hebei, 54001

    Zongjiu Jiao, Doctor, 18631921299, 1449569258@qq.com

  • Yulin Red Cross Hospital

    Yulin, Guangxi, 537000

    Zhao Lv, Bachelor, 15277931749, 371535062@qq.com

  • Henan Children's Hospital

    Zhengzhou, Henan, 450018

    Wei Liu, Doctor, 13673710016, liuweixinxiang@163.com

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

    Yan Chen, Doctor, 13985261758, cyz600@163.com

Other trials in China

About this study

Official title: The Efficacy and Safety of Nelarabine Injection in the Treatment of Refractory or Recurrent T-lymphoblastic Leukemia (T-ALL) and T-lymphoblastic Lymphoma (T-LBL) in Children and Adults

This is a single-arm, open-label, multicenter, phase III clinical study that aims to evaluate the efficacy and safety of Nelarabine injection in the treatment of refractory or recurrent T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) in both children and adults. The trial includes 83 subjects, consisting of 35 adults and 48 children, and aims to evaluate the composite complete response rate (CCR) within 2 cycles, assessed by the Independent Review Committee (IRC), following treatment with Nelarabine injection for children and adults with refractory or recurrent T-ALL and T-LBL.

The sample size of this study is estimated according to the treatment period of 4 cycles.

Being tested
Nelarabine injection
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Nelarabine injectionDrug

    Nelarabine is a prodrug of the nucleotide metabolism inhibitor deoxyguanosine analogue 9-β-arabinoguanine (ARA-G). Nelarabine undergoes catalytic transformation by adenosine deaminase (ADA), resulting in the removal of its methoxy group and conversion into ARA-G, Subsequently, ARA-G undergoes sequential monophosphorylation by deoxyguanosine kinase and deoxycytosine nucleoside kinase, yielding the active compound 5'-Guanosine triphosphate (GTP), ARA-GTP. This active compound accumulates within leukemic blast cells and binds to deoxyribonucleic acid (DNA), effectively inhibiting DNA synthesis and ultimately leading to cell death.

Study groups in NCT06434467
Study groupRoleWhat they receive
Nelarabine injectionExperimentalAdults (≥18 years old): 1500 mg/m², administer intravenously for at least 2 hours on days 1, 3, and 5, repeating every 21 days. Children (1-17 years old): 650 mg/m ², administer intravenously for 1 hour daily for 5 consecutive days, repeating every 21 days.
Receives: Drug: Nelarabine injection

What is being measured

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

  1. Composite complete response rate (CCR) assessed by the Independent Review Committee (IRC)

    Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by independent review committee (IRC) assessment

    Measured: During the study period (Baseline up to two months)

Secondary outcomes (11)

  1. Composite complete response rate (CCR) assessed by the investigator

    Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by the investigator.

    Measured: During the study period (Baseline up to two months)

  2. Objective Remission Rate (ORR)

    The best Objective Remission Rate (ORR) for both complete response (CR) and partial response (PR) cases within 2 cycles.

    Measured: During the study period (Baseline up to two months)

  3. Duration of complete remission (DOCR)

    Proportion of patients whose tumor shrinks or stabilizes for some time, including cases of complete response (CR), partial response (PR), and stable disease (SD).

    Measured: During the study period (Baseline up to two years)

  4. Disease-free survival (DFS)

    It refers to the time from the first day of absence of disease to the recurrence of disease.

    Measured: During the study period (Baseline up to two years)

  5. Overall survival (OS)

    It indicates the time interval from randomization to death from any cause.

    Measured: During the study period (Baseline up to two years)

  6. Incidence of adverse events (AEs)

    Adverse events refer to all adverse medical events that occur after a patient or clinical trial subject receives an experimental drug, which can be expressed as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily related to the treatment of the experimental drug.

    Measured: During the study period (Baseline up to two years)

  7. Incidence of serious adverse events (SAEs)

    Serious adverse events include death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and adverse medical conditions such as congenital abnormalities or birth defects.

    Measured: During the study period (Baseline up to two years)

  8. Peak time (Tmax)

    Time to maximum plasma concentration.

    Measured: During the study period (Baseline up to two years)

  9. Peak concentration(Cmax)

    Pharmacokinetic parameters, including but not limited to: Peak concentration(Cmax)

    Measured: During the study period (Baseline up to two years)

  10. Half-life(t1/2)

    It is the time required for half of the drug to be eliminated from the plasma

    Measured: During the study period (Baseline up to two years)

  11. Negative rate of minimal residual disease in bone marrow (MRD)

    The proportion of trace leukemic cells negative in patients with hematologic tumors after treatment.

    Measured: During the study period （Baseline up to two years)

Timeline

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

  1. First posted30 May 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMay 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434467
Sponsor's protocol ID
NLB-III-01
Status last verified
Nov 2023
First submitted
17 May 2024
Last updated
30 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nelarabine injection in people with T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 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 20 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 Jun Ma, Doctor (13304518000, majun0322@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite complete response rate (CCR) assessed by the Independent Review Committee (IRC) (time frame: During the study period (Baseline up to two 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 NCT06434467.

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 30 May 2024.

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