Effects of ChemotherapyPhase 2NCT02306837
Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies
A Phase 2 study testing Bu-CY-E in people with Effects of Chemotherapy, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Effects of Chemotherapy
- What is being tested?
- Bu-CY-E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2014to Sep 2019
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
- ECOG: 0-2
- Tbil < 1.5x ULN and AST/ALT <2.5x ULN
- With informed consent
Who cannot join
- Life expectancy < 3 months
- Women in pregnancy
- uncontrollable infection disease
- serum Cr >400mmol/l
- uncontroled diabetis and heart disease
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, 200025
Jiong HU, M.D., 0086-64370045 ext. 601818, hujiong@medmail.com.cn
Jiong HU, M.D.
- Recruiting
Shanghai No 10 Hospital
Shanghai
JunMei Shi, M.D, Ph.D,
JunMei Shi, M.D, Ph.D,
About this study
Official title: A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation
Read the detailed description
Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.
- Conditions
- Effects of Chemotherapy
- Being tested
- Bu-CY-E
- Keywords
- lymphoma, consolidation chemotherapy, auto-HSCT
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu-CY-EDrug
Also called mini Bu-Cy-E
mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT
| Study group | Role | What they receive |
|---|---|---|
| Consolidation chemo | Experimental | Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen Receives: Drug: Bu-CY-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 2-year
Secondary outcomes (3)
overall survival
Measured: 2-year
progression
PET-CT measurement
Measured: 2-year
transplantation-related mortality
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong Hu, M.D,, Principal investigator, Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306837
- Sponsor's protocol ID
- Lym-Auto-RJH-2014
- Status last verified
- Sep 2016
- First submitted
- 1 Dec 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02306837
- Acronym / sponsor ID
- Lym-Auto-RJH-2014
- Conditions
- Effects of Chemotherapy
- Keywords
- lymphoma, consolidation chemotherapy, auto-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 3 Dec 2014 (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.
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation
Detailed description
Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consolidation chemo | Experimental | Drug: Bu-CY-EPatients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
- ECOG: 0-2
- Tbil < 1.5x ULN and AST/ALT <2.5x ULN
- With informed consent
Key exclusion criteria (5 listed)
- Life expectancy < 3 months
- Women in pregnancy
- uncontrollable infection disease
- serum Cr >400mmol/l
- uncontroled diabetis and heart disease
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 |
|---|---|---|
| Bu-CY-EAlso: mini Bu-Cy-Emini Bu-Cy-E as consolidation chemotherapy after autologous HSCT | Drug | Consolidation chemo |
Primary outcome
progression free survival
Time frame: 2-year
3 secondary outcomes
overall survival
Time frame: 2-year
progression
Time frame: 2-year
transplantation-related mortality
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jiong Hu, M.D, principal investigator
Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bu-CY-E in people with Effects of Chemotherapy, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 4 inclusion and 5 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 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jiong Hu, M.D, (86-21-64370045 ext. 601878, hujiong@medmail.com.cn), 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: 2-year). 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 8 Sep 2016.