T-lymphoblastic LymphomaPhase 4NCT03558412
A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
A Phase 4 study testing CODOX-M/IVAC and Decitabine in people with T-lymphoblastic Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial summary
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- T-lymphoblastic Lymphoma
- What is being tested?
- CODOX-M/IVAC and Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2020
- Phase
- Phase 4
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age: 14~60 years; ECOG rate ≤ 2; expected survival > 3 months;
- patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;
- patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;
- patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen;
- at least one measurable nidus;
- no other severe diseases conflict with this project, cardiopulmonary function is basically normal;
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- the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit;
- applicable for follow-up visit;
- no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable;
- understanding this study and assigning informed consent.
Who cannot join
- rejecting providing blood preparation;
- allergic to drug in this study and with metabolic block;
- rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas);
- with severe infection;
- with primary or secondary central nervous system tumor invasion;
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- with immunotherapy or radiotherapy contraindication;
- ever suffered with malignant tumor;
- having peripheral nervous system disorder or dysphrenia;
- with no legal capacity, medical or ethical reasons affecting research proceeding;
- participating other clinical trials simultaneously;
- adopting other anti-tumor medicine excluding this research;
- the researchers considering it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro,Dr, 13838565629, mingzhi_zhang@126.com
Mingzhi Zhang, Pro,Drc, 13838565629, mingzhi_zhang@126.com
About this study
Official title: A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
Read the detailed description
This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
- Conditions
- T-lymphoblastic Lymphoma
- Being tested
- CODOX-M/IVAC, Decitabine
- Keywords
- Decitabine, RR, TTP, OS, MST
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CODOX-M/IVACCombination product
Given ivgtt
DecitabineDrug
Also called 5-Aza-2'-deoxycytidine
Given ivgtt
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B. Receives: Combination Product: CODOX-M/IVAC; Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RR
Responder Rate
Measured: up to 2 months
TTP
Time To Progression
Measured: up to 2 months
Secondary outcomes (2)
OS
Overall Survival
Measured: up to 2 months
MST
Median Survival Time
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Jun 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-lymphoblastic LymphomaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558412
- Sponsor's protocol ID
- hnslblzlzx20171118
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT03558412
- Acronym / sponsor ID
- hnslblzlzx20171118
- Conditions
- T-lymphoblastic Lymphoma
- Keywords
- Decitabine, RR, TTP, OS, MST
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 15 Jun 2018 (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.
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
Detailed description
This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Combination Product: CODOX-M/IVAC, Drug: DecitabineDecitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- age: 14~60 years; ECOG rate ≤ 2; expected survival > 3 months;
- patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;
- patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;
- patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen;
- at least one measurable nidus;
Key exclusion criteria (13 listed)
- rejecting providing blood preparation;
- allergic to drug in this study and with metabolic block;
- rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas);
- with severe infection;
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 |
|---|---|---|
| CODOX-M/IVACGiven ivgtt | Combination product | Arm A |
| DecitabineAlso: 5-Aza-2'-deoxycytidineGiven ivgtt | Drug | Arm A |
Primary outcome
RR
Time frame: up to 2 months
Responder Rate
TTP
Time frame: up to 2 months
Time To Progression
2 secondary outcomes
OS
Time frame: up to 2 months
MST
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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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.
Mingzhi zhang principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CODOX-M/IVAC and Decitabine in people with T-lymphoblastic Lymphoma, run by Mingzhi Zhang 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 10 inclusion and 13 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 14 Sep 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mingzhi zhang, Pro,Dr (13838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RR (time frame: up to 2 months). The study lists 2 primary outcomes in all. 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 14 Sep 2018.