Peripheral T-cell LymphomaPhase 3NCT04880746
Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
A Phase 3 study testing BEAC and Cladribine combined with BEAC in people with Peripheral T-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- BEAC and Cladribine combined with BEAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2020to 17 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18-65 years old, no gender limit;
- ECOG 0-2, estimated survival time ≥ 3 months;
- Pathologically newly diagnosed with PTCL (except ALK+ anaplastic large cell lymphoma), with PR or CR after 6 cycles of induction chemotherapy;
- Hb≥80g/L, ANC≥1.0×10^9/L, PLT≥75×10^9/L; TBIL≤1.5×ULN, ALT/AST≤2.0× ULN, Cr ≤1.5×ULN in the 14 days before enrollment
- Have not received hematopoietic stem cell transplantation and other treatments within 4 weeks before enrollment;
- The number of hematopoietic stem cells requires MNC ≥3×10^8/kg and/or CD34 cells ≥2×10^6/kg;
- Informed consented
Who cannot join
- Accompanied by severe cardiac insufficiency, cardiac ejection fraction <60%; or severe arrhythmia, intolerance of pretreatment;
- Accompanied by severe pulmonary insufficiency (obstructive and or restrictive ventilatory disorders), intolerance of pretreatment;
- Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal, intolerance of pretreatment;
- Accompanied by severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal; or the 24-hour urine creatinine clearance rate Ccr is less than 50ml/min, intolerance of pretreatment;
- Severe active infection before transplantation, intolerance of pretreatment;
- Accompanied by brain dysfunction or severe mental illness, unable to understand or follow the research plan;
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- Pregnant or lactation；
- Accompanied by other malignant tumors in need of treatment;
- Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Weili Zhao, +862164370045, zwl_trial@163.com
About this study
Official title: Efficacy and Safety of Cladribine Combined With BEAC ( Semustine, Etoposide, Cytarabine, Cyclophosphamide) Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
This multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma.
Read the detailed description
Peripheral T-cell lymphomas (PTCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas originating from mature post-thymic T lymphocytes or NK/T cells. The treatment effect of patients receiving autologous hematopoietic stem cell transplantation (ASCT) is better than traditional chemotherapy, but the recurrence after transplantation is still as high as 50%. It is an urgent clinical problem to reduce the recurrence after PTCL transplantation. Cladribine can kill quiescent tumor cells, which is the main reason of tumor recurrence. Since 2018, our center has used cladribine combined with BEAC pretreatment regimen to treat 20 patients with PTCL. The PFS reached 68% at 2 years, which is about 15% higher than the previous classic BEAC regimen. This multi-center clinical study will further evaluate the efficacy and safety of Cladribine combined with BEAC pretreatment regimen in the Treatment of Peripheral T-cell Lymphoma.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- BEAC, Cladribine combined with BEAC
- Keywords
- Peripheral T-cell lymphoma, Autologous stem cell transplantation, Cladribine, BEAC
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEACDrug
Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d
Cladribine combined with BEACDrug
Cladribine, 6mg/m2，-5～-2d, two hours before Cytarabine Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d
| Study group | Role | What they receive |
|---|---|---|
| BEAC | Active comparator | Patients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT Receives: Drug: BEAC |
| Cladribine combined with BEAC | Experimental | Patients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT Receives: Drug: Cladribine combined with BEAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes (5)
Overall survival
Overall survival was defined as the time from the date of ASCT to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Overall remission rate
Percentage of participants with overall response was determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.
Measured: 3 months after the transplantation
Transplantation-related adverse reactions
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT
Measured: Baseline up to data cut-off (up to approximately 5 years)
Patient tolerance
Percentage of participants who can tolerate the whole treatment of ASCT
Measured: Through the whole course of ASCT, an average of one month
Relapse rate
Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.
Measured: Baseline up to data cut-off (up to approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start17 Oct 2020
- Primary completion17 Oct 2024 (estimated)
- Study completion17 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, The First Affiliated Hospital of Anhui Medical University, Harbin Hematology and Oncology Institute, Affiliated Zhongshan Hospital of Dalian University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880746
- Sponsor's protocol ID
- ASCT-001
- Status last verified
- May 2021
- First submitted
- 17 Apr 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cladribine Combined With BEAC ( Semustine, Etoposide, Cytarabine, Cyclophosphamide) Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04880746
- Acronym / sponsor ID
- ASCT-001
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Peripheral T-cell lymphoma, Autologous stem cell transplantation, Cladribine, BEAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, The First Affiliated Hospital of Anhui Medical University, Harbin Hematology and Oncology Institute, Affiliated Zhongshan Hospital of Dalian University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 17 Oct 2024 (estimated)
- Study completion
- 17 Oct 2025 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma.
Detailed description
Peripheral T-cell lymphomas (PTCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas originating from mature post-thymic T lymphocytes or NK/T cells. The treatment effect of patients receiving autologous hematopoietic stem cell transplantation (ASCT) is better than traditional chemotherapy, but the recurrence after transplantation is still as high as 50%. It is an urgent clinical problem to reduce the recurrence after PTCL transplantation. Cladribine can kill quiescent tumor cells, which is the main reason of tumor recurrence. Since 2018, our center has used cladribine combined with BEAC pretreatment regimen to treat 20 patients with PTCL. The PFS reached 68% at 2 years, which is about 15% higher than the previous classic BEAC regimen. This multi-center clinical study will further evaluate the efficacy and safety of Cladribine combined with BEAC pretreatment regimen in the Treatment of Peripheral T-cell Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEAC | Active comparator | Drug: BEACPatients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT |
| Cladribine combined with BEAC | Experimental | Drug: Cladribine combined with BEACPatients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old, no gender limit;
- ECOG 0-2, estimated survival time ≥ 3 months;
- Pathologically newly diagnosed with PTCL (except ALK+ anaplastic large cell lymphoma), with PR or CR after 6 cycles of induction chemotherapy;
- Hb≥80g/L, ANC≥1.0×10^9/L, PLT≥75×10^9/L; TBIL≤1.5×ULN, ALT/AST≤2.0× ULN, Cr ≤1.5×ULN in the 14 days before enrollment
- Have not received hematopoietic stem cell transplantation and other treatments within 4 weeks before enrollment;
Key exclusion criteria (9 listed)
- Accompanied by severe cardiac insufficiency, cardiac ejection fraction <60%; or severe arrhythmia, intolerance of pretreatment;
- Accompanied by severe pulmonary insufficiency (obstructive and or restrictive ventilatory disorders), intolerance of pretreatment;
- Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal, intolerance of pretreatment;
- Accompanied by severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal; or the 24-hour urine creatinine clearance rate Ccr is less than 50ml/min, intolerance of pretreatment;
- Severe active infection before transplantation, intolerance of pretreatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEACSemustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d | Drug | BEAC |
| Cladribine combined with BEACCladribine, 6mg/m2，-5～-2d, two hours before Cytarabine Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d | Drug | Cladribine combined with BEAC |
Primary outcome
Progression free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007, or death from any cause, whichever occurred first.
5 secondary outcomes
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall remission rate
Time frame: 3 months after the transplantation
Transplantation-related adverse reactions
Time frame: Baseline up to data cut-off (up to approximately 5 years)
Patient tolerance
Time frame: Through the whole course of ASCT, an average of one month
Relapse rate
Time frame: Baseline up to data cut-off (up to approximately 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weili Zhao study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BEAC and Cladribine combined with BEAC in people with Peripheral T-cell Lymphoma, run by Ruijin Hospital 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Baseline up to data cut-off (up to approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.