LymphomaPhase 4NCT02929615
Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
A Phase 4 study testing Hematopoietic stem cell transplantation in people with Lymphoma, run by Peking University at 1 site in China.
Trial summary
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Hematopoietic stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Mar 2018
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with relapse and refractory lymphoma and multiple myeloma.
- At least 1 measurable lesions and its size≥15mm.
- Patients ≤65 years，no limitations for both gender.
- ECOG score is 0-1.
- Life expectancy≥3 months.
- LVEF≥ 55%; Peripheral blood: WBC ≥ 3.5×10(9)/L,neutrophil ≥1.5×10(9)/L, PLT≥75×109/L，Hb≥90g/L; Renal function: Cr≤2.0×UNL; Liver function: BIL≤2.0×UNL，ALT/AST≤2.5×UNL;
- Written informed consent are acquired.
Who cannot join
- Previously received stem cell transplantation.
- Women with pregnant, lactating or not to take contraceptive measures.
- Severe acute infection or suppurative and chronic infection that wound not healing.
- Severe heart failure.
- Suffering from mental disorders and poor compliance.
- Other situations that investigators consider as contra-indication for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Study site
Beijing, Beijing Municipality, 100142
Zhu Jun, archiater, 010-88196596, Zhujun@csco.org
About this study
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.
- Conditions
- Lymphoma
- Being tested
- Hematopoietic stem cell transplantation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic stem cell transplantationOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Other: Hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 2 years after treatment
complete response
Measured: 2 years after treatment
progression-free survival
Measured: 2 years after treatment
overall survival
Measured: 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929615
- Sponsor's protocol ID
- v1.0-20150805
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
- ClinicalTrials.gov ID
- NCT02929615
- Acronym / sponsor ID
- v1.0-20150805
- Conditions
- Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- 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.
The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Hematopoietic stem cell transplantation |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with relapse and refractory lymphoma and multiple myeloma.
- At least 1 measurable lesions and its size≥15mm.
- Patients ≤65 years，no limitations for both gender.
- ECOG score is 0-1.
- Life expectancy≥3 months.
Key exclusion criteria (6 listed)
- Previously received stem cell transplantation.
- Women with pregnant, lactating or not to take contraceptive measures.
- Severe acute infection or suppurative and chronic infection that wound not healing.
- Severe heart failure.
- Suffering from mental disorders and poor compliance.
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 |
|---|---|---|
| Hematopoietic stem cell transplantation | Other | Treatment group |
Primary outcome
overall response rate
Time frame: 2 years after treatment
complete response
Time frame: 2 years after treatment
progression-free survival
Time frame: 2 years after treatment
overall survival
Time frame: 2 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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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.
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 Hematopoietic stem cell transplantation in people with Lymphoma, run by Peking University 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 6 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 12 Oct 2016. 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 Zhu Jun, archiater (010-88196596, Zhujun@csco.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 2 years after treatment). The study lists 4 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 12 Oct 2016.