No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
28 (estimated)
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University · Other
Who this trial is looking for
This trial is looking for adults with certain types of blood cancer, such as Burkitt lymphoma and acute lymphoblastic leukemia. Participants will receive a specific treatment before undergoing a stem cell transplant, followed by one year of maintenance treatment to check for effectiveness and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with Burkitt lymphoma or acute lymphoblastic leukemia.
I received specific chemotherapy treatment before.
I can cooperate with the requirements of the study.
I have not had any cancer treatments in the last 3 years, except for certain skin cancers.
I have a performance status score of 0-2.
I have achieved remission or am at a specific treatment stage.
You may not be able to join if
I have a history of cancer and received treatment in the past 3 years.
I am pregnant or cannot take contraceptive measures.
I have tested positive for HIV or active hepatitis.
I have active heart disease or serious heart conditions.
I am planning major surgery in the next 4 weeks.
I have taken live vaccines within 4 weeks before the trial.
I have mental illness that interferes with my involvement.
I have participated in other clinical trials in the past month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 transplantati…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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 …
Inclusion 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 (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;
Exclusion Criteria:
* 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:
1. Have a history of uncontrolled or symptomatic angina;
2. Myocardial infarction less than 6 months from study enrollment;
3. Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;
4. Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2);
5. The ejection fraction is lower than the lower limit of the normal range. 7. Patients who meet the following criteria:
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1. 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;
2. Those who have received (attenuated) live vaccines within 4 weeks before enrollment;
3. Patients with suspected active or latent tuberculosis;
4. Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment
Contacts
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