AzTrials
AzTrials

Burkitt LymphomaPhase 1TCCANCT06060782

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

A Phase 1 study testing Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen in people with Burkitt Lymphoma and Lymphoblastic Lymphoma, Adult, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditioning regimen. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
6 Mar 2024to 31 Dec 2026
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntarily sign the informed consent form, which must be signed by the patient himself.
  • 2. ALL patients confirmed by bone marrow cell morphology, immunology, and genetics; 3. PH+ALL patients who achieve s3CMR (definition: achieve molecular biological remission in the early stage of initial treatment (within 3 months) and maintain remission); 4. Ph-B-ALL patients who have reached MRD- after 3 courses of chemotherapy and continue to be MRD-; adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics; 5. Adult patients with Burkitt lymphoma and lymphoblastoma, if the bone marrow is not involved, can achieve PR or above after induction; if the bone marrow is involved at the time of initial diagnosis, 3 courses of chemotherapy are required to reach MRD- and continue to be MRD-.
  • 6. Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2;

Who cannot join

  • 1. Have a history of cancer and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN), or prostate epithelium Internal carcinogenesis (PIN); 2. Known to be serologically positive for HIV, active hepatitis B, active hepatitis C virus or syphilis; 3. Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation within the past 1 year; 6. Active heart disease, defined as one or more of the following:
  • Have a history of uncontrolled or symptomatic angina;
  • Myocardial infarction less than 6 months from study enrollment;
  • Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;
  • Uncontrolled or symptomatic congestive heart failure (>NYHA class 2);
  • The ejection fraction is lower than the lower limit of the normal range. 7. Patients who meet the following criteria:
Show all 11Show fewer
  • <!-- -->
  • Major surgery (except diagnostic surgery) is planned within 4 weeks before enrollment or during the study period, or the surgical wound has not fully healed before enrollment;
  • Those who have received (attenuated) live vaccines within 4 weeks before enrollment;
  • Patients with suspected active or latent tuberculosis;
  • Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    juan Lin Zeng, PhD, 13825613357, zenglinj@mail.sysu.edu.cn

    Juan Zhuang, Master's degree, 13926926178, zhuangj5@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study on the Efficacy and Safety of Auto-HSCT in Adult Patients with Burkitt Lymphoma, Lymphoblastic Lymphoma, and Acute Lymphoblastic Leukemia Who Received TCCA Conditioning Regimen

This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditioning regimen. The study plans to include 28 patients who received the TCCA regimen for pre-transplantation pretreatment before auto-HSCT. Maintenance treatment will be carried out after transplantation for 1 year to observe the efficacy and safety.

Being tested
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
Keywords
Thiotepa, Cyclophosphamide, Cladribine, Cytarabine, conditioning regimen
Medical subject headings
Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimenDrug

    Also called TCCA conditioning regimen group

    All enrolled patients received TCCA conditioning regimen（） before auto-HSCT:

    Thiotepa 5mg/kg, -8, -7 days Cyclophosphamide 40mg/kg, -6, -5 days Cladribine 5mg/m2, -4, -3, -2 days Cytarabine 2g/m2, -4, -3, -2 days

Study groups in NCT06060782
Study groupRoleWhat they receive
subject groupExperimentalNot described
Receives: Drug: Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen

What is being measured

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

  1. 3-year recurrence-free survival rate

    Measured: 3 years after transplantation

Secondary outcomes (5)

  1. 3-year overall survival rate

    Measured: 3 years after transplantation

  2. 3-year recurrence rate

    Measured: 3 years after transplantation

  3. Transplant-related mortality

    Measured: From the beginning of conditioning to 3 years after transplantation

  4. The patient's tolerance and mucositis grade

    Measured: From the beginning of conditioning chemotherapy to hematopoietic reconstitution

  5. The incidence of cataracts and second tumors

    Measured: From the beginning of conditioning to 3 years after transplantation

Timeline

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

  1. First posted29 Sep 2023
  2. Study start6 Mar 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060782
Sponsor's protocol ID
ZDWY.XYZLK.002
Acronym
TCCA
Status last verified
Mar 2025
First submitted
25 Sep 2023
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen in people with Burkitt Lymphoma and Lymphoblastic Lymphoma, Adult, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year recurrence-free survival rate (time frame: 3 years after transplantation). 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 NCT06060782.

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 6 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in