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New treatment option for Burkitt Lymphoma
Official title Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
ClinicalTrials.gov ID: NCT06060782
What this study is testing
What is Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen?
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen is an investigational medicine, being studied as a potential treatment for burkitt lymphoma.
Also referred to as TCCA conditioning regimen group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 6\. Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern...
You likely can't join if
- 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...
- 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:
See the full eligibility criteria
- 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...
- 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;
- 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...
- 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:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zhuhai, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhuhai, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.