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Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine (TCCA)

Primary Purpose

Burkitt Lymphoma, Lymphoblastic Lymphoma, Adult, Acute Lymphoblastic Leukemia, Adult

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
Sponsored by
Fifth Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burkitt Lymphoma focused on measuring Thiotepa, Cyclophosphamide, Cladribine, Cytarabine, conditioning regimen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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: 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

Sites / Locations

  • The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subject group

Arm Description

Outcomes

Primary Outcome Measures

3-year recurrence-free survival rate

Secondary Outcome Measures

3-year overall survival rate
3-year recurrence rate
Transplant-related mortality
The patient's tolerance and mucositis grade
The incidence of cataracts and second tumors

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT06060782
Brief Title
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Acronym
TCCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt Lymphoma, Lymphoblastic Lymphoma, Adult, Acute Lymphoblastic Leukemia, Adult
Keywords
Thiotepa, Cyclophosphamide, Cladribine, Cytarabine, conditioning regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
subject group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen
Other Intervention Name(s)
TCCA conditioning regimen group
Intervention Description
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
Primary Outcome Measure Information:
Title
3-year recurrence-free survival rate
Time Frame
3 years after transplantation
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Time Frame
3 years after transplantation
Title
3-year recurrence rate
Time Frame
3 years after transplantation
Title
Transplant-related mortality
Time Frame
From the beginning of conditioning to 3 years after transplantation
Title
The patient's tolerance and mucositis grade
Time Frame
From the beginning of conditioning chemotherapy to hematopoietic reconstitution
Title
The incidence of cataracts and second tumors
Time Frame
From the beginning of conditioning to 3 years after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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: 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
Facility Information:
Facility Name
The Fifth Affiliated Hospital of Sun Yat-sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
juan Lin Zeng, PhD
Phone
13825613357
Email
zenglinj@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Juan Zhuang, Master's degree
Phone
13926926178
Email
zhuangj5@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine

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