Diffuse Large B Cell LymphomaPhase 4NCT03579082
A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma
A Phase 4 study testing Decitabine in people with Diffuse Large B Cell Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial summary
To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Decitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age:14-65 years;ECOG rate≤2;expected survival≥3 months
- patients with Diffuse Large B cell lymphoma diagnoesd by histopathology detection;
- patients ever received RCHOP or CHOP chemotherapy but did not receive DHAP
- patients never received radiotherapy
- patients with no chemotherapy contraindications:hemoglobin ≥ 90g/L,absoluate neutrophil count ≥1.5x109/L,blood platelet ≥100x109/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 ≥ 30g/L,normal serofibrinogen;
- at least one measurable nidus;
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- no other severe diseases conflict with this project,cardiopulmonary function is basically normal
- 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 Affilliated 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
To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.
Read the detailed description
This is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with R±DHAP in replase and refractory Diffuse Large B cell lymphoma.A total of 60 patients are planned to be enrolled into the study.Patients with diagnosis of replase and refractory Diffuse Large B cell lymphoma will be into two groups,and be treated with decitabine pluse R±DHAP or only R±DHAP,respectively.The primary end points are objective responder rate(ORR) and time to progression(TTP) and the secondary end points include overall survival(OS) and progression free survival(PFS).
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Decitabine
- Keywords
- Decitabine, ORR, TTP, OS, PFS
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called 5-Aza-2'-deoxycytidine
Given ivgtt
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | R±DHAP + decitabine:
decitabine:10mg/d,ivgtt,d(-5)-(-1);R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. Receives: Drug: Decitabine |
| Arm B | No intervention | R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective 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
PFS
Progression Free Survival
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 posted6 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Cell 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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 affilliated hospital of zhengzhou university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579082
- Sponsor's protocol ID
- hnslblzlzx20171211
- Status last verified
- Sep 2018
- First submitted
- 14 Dec 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hu J, Wang X, Chen F, Ding M, Dong M, Yang W, Yin M, Wu J, Zhang L, Fu X, Sun Z, Li L, Wang X, Li X, Guo S, Zhang D, Lu X, Leng Q, Zhang M, Zhu L, Zhang X, Chen Q. Combination of Decitabine and a Modified Regimen of Cisplatin, Cytarabine and Dexamethasone: A Potential Salvage Regimen for Relapsed or Refractory Diffuse Large B-Cell Lymphoma After Second-Line Treatment Failure. Front Oncol. 2021 Jun 18;11:687374. doi: 10.3389/fonc.2021.687374. eCollection 2021.
PubMed 34222013
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 in Relapse and Refractory Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03579082
- Acronym / sponsor ID
- hnslblzlzx20171211
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Decitabine, ORR, TTP, OS, PFS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 6 Jul 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 R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.
Detailed description
This is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with R±DHAP in replase and refractory Diffuse Large B cell lymphoma.A total of 60 patients are planned to be enrolled into the study.Patients with diagnosis of replase and refractory Diffuse Large B cell lymphoma will be into two groups,and be treated with decitabine pluse R±DHAP or only R±DHAP,respectively.The primary end points are objective responder rate(ORR) and time to progression(TTP) and the secondary end points include overall survival(OS) and progression free survival(PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: DecitabineR±DHAP + decitabine: decitabine:10mg/d,ivgtt,d(-5)-(-1);R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. |
| Arm B | No intervention | –R±DHAP:rituximab,375mg/m2,d0,ivgtt;cytarabine,2g/m2,q12h,d2,ivgtt;cisplatin,100mg/m2,used for 3 days,ivgtt;dexamethasone,40mg,d1-4,ivgtt/po.21 days for one cycle. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- age:14-65 years;ECOG rate≤2;expected survival≥3 months
- patients with Diffuse Large B cell lymphoma diagnoesd by histopathology detection;
- patients ever received RCHOP or CHOP chemotherapy but did not receive DHAP
- patients never received radiotherapy
- patients with no chemotherapy contraindications:hemoglobin ≥ 90g/L,absoluate neutrophil count ≥1.5x109/L,blood platelet ≥100x109/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 ≥ 30g/L,normal serofibrinogen;
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 |
|---|---|---|
| DecitabineAlso: 5-Aza-2'-deoxycytidineGiven ivgtt | Drug | Arm A |
Primary outcome
ORR
Time frame: up to 2 months
Objective Responder Rate
TTP
Time frame: up to 2 months
Time TO Progression
2 secondary outcomes
OS
Time frame: up to 2 months
PFS
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.
- Derived from this study: PubMed 34222013Hu J, Wang X, Chen F, Ding M, Dong M, Yang W, Yin M, Wu J, Zhang L, Fu X, Sun Z, Li L, Wang X, Li X, Guo S, Zhang D, Lu X, Leng Q, Zhang M, Zhu L, Zhang X, Chen Q. Combination of Decitabine and a Modified Regimen of Cisplatin, Cytarabine and Dexamethasone: A Potential Salvage Regimen for Relapsed or Refractory Diffuse Large B-Cell Lymphoma After Second-Line Treatment Failure. Front Oncol. 2021 Jun 18;11:687374. doi: 10.3389/fonc.2021.687374. eCollection 2021.
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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 affilliated 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 Decitabine in people with Diffuse Large B Cell 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 11 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?
ORR (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?
On the ClinicalTrials.gov record for NCT03579082, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.