Loading clinical trials...

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

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

NCT06060782•Fifth Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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:
•
•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;
+1 more criteria

Locations (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Key Dates

Start Date

March 6, 2024

Primary Completion Date

August 31, 2026

Completion Date

December 31, 2026

Last Updated

March 6, 2025

Enrollment

ESTIMATED participants

Conditions

Burkitt LymphomaLymphoblastic Lymphoma, AdultAcute Lymphoblastic Leukemia, Adult

Interventions

Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen

DRUG

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

NCT04195633

Acute LeukemiaAcute Lymphoblastic Leukemia+17 more

View study

RECRUITINGPHASE1

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

NCT04739813

LymphomaNon-Hodgkin Lymphoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

Inclusion Criteria

Exclusion Criteria

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.