LeukemiaNCT01455272
New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation
A study testing prophylactic GPBPCI in people with Leukemia, run by Peking University People's Hospital at 6 sites in China.
Trial summary
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- prophylactic GPBPCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesChina
- Study dates
- Jul 2009to Mar 2015
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- high-risk leukemia after HSCT
Who cannot join
- active GVHD
- early relapse
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking University People's Hospital，Institute of Hematology
Beijing, 100044
Xinqiao Hospital,Third Military Medical University
Chongqing
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang
Lanzhou General Hospital of Lanzhou Command
Lanzhou, Gansu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
Official title: Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.
It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.
Read more
The study hypothesis:
Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can
- reduce relapse rate
- improve survival
Read the detailed description
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.
- Conditions
- Leukemia
- Being tested
- prophylactic GPBPCI
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic GPBPCIProcedure or surgery
Also called modified DLI
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
| Study group | Role | What they receive |
|---|---|---|
| high-risk leukemia | Experimental | Not described Receives: Procedure: prophylactic GPBPCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
Measured: one year after HSCT
Secondary outcomes (1)
survival probability
Measured: one year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJul 2009
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang, Peking University People's Hospital
- Investigators
- XiaoJun Huang, M.D., Principal investigator, Peking University People's Hospital，Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455272
- Sponsor's protocol ID
- PUPH IRB [2010] (78)
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yan CH, Wang Y, Sun YQ, Cheng YF, Mo XD, Wang FR, Chen YH, Zhang YY, Han TT, Chen H, Xu LP, Zhang XH, Liu KY, Huang XJ. Optimized therapeutic strategy for patients with refractory or relapsed acute myeloid leukemia: long-term clinical outcomes and health-related quality of life assessment. Cancer Commun (Lond). 2022 Dec;42(12):1387-1402. doi: 10.1002/cac2.12376. Epub 2022 Oct 23.
PubMed 36274263Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
PubMed 32103499Yan CH, Liu QF, Wu DP, Zhang X, Xu LP, Zhang XH, Wang Y, Huang H, Bai H, Huang F, Ma X, Huang XJ. Prophylactic Donor Lymphocyte Infusion (DLI) Followed by Minimal Residual Disease and Graft-versus-Host Disease-Guided Multiple DLIs Could Improve Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Refractory/Relapsed Acute Leukemia. Biol Blood Marrow Transplant. 2017 Aug;23(8):1311-1319. doi: 10.1016/j.bbmt.2017.04.028. Epub 2017 May 5.
PubMed 28483716
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Granulocyte Colony-stimulating Factor (G-CSF)-Primed, Peripheral-blood Progenitor Cells for the Prevention of Relapse Advanced Stage Leukemia
- ClinicalTrials.gov ID
- NCT01455272
- Acronym / sponsor ID
- PUPH IRB [2010] (78)
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Oct 2011 (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.
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.
It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.
The study hypothesis:
Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can
- reduce relapse rate
- improve survival
Detailed description
A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-risk leukemia | Experimental | Procedure: prophylactic GPBPCI |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- high-risk leukemia after HSCT
Key exclusion criteria (2 listed)
- active GVHD
- early relapse
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 |
|---|---|---|
| prophylactic GPBPCIAlso: modified DLIA G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed | Procedure or surgery | high-risk leukemia |
Primary outcome
relapse rate
Time frame: one year after HSCT
1 secondary outcome
survival probability
Time frame: one year after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 36274263Yan CH, Wang Y, Sun YQ, Cheng YF, Mo XD, Wang FR, Chen YH, Zhang YY, Han TT, Chen H, Xu LP, Zhang XH, Liu KY, Huang XJ. Optimized therapeutic strategy for patients with refractory or relapsed acute myeloid leukemia: long-term clinical outcomes and health-related quality of life assessment. Cancer Commun (Lond). 2022 Dec;42(12):1387-1402. doi: 10.1002/cac2.12376. Epub 2022 Oct 23.
- Derived from this study: PubMed 32103499Zhou YL, Wu LX, Peter Gale R, Wang ZL, Li JL, Jiang H, Jiang Q, Jiang B, Cao SB, Lou F, Sun Y, Wang CC, Liu YR, Wang Y, Chang YJ, Xu LP, Zhang XH, Liu KY, Ruan GR, Huang XJ. Mutation topography and risk stratification for de novo acute myeloid leukaemia with normal cytogenetics and no nucleophosmin 1 (NPM1) mutation or Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD). Br J Haematol. 2020 Jul;190(2):274-283. doi: 10.1111/bjh.16526. Epub 2020 Feb 26.
- Derived from this study: PubMed 28483716Yan CH, Liu QF, Wu DP, Zhang X, Xu LP, Zhang XH, Wang Y, Huang H, Bai H, Huang F, Ma X, Huang XJ. Prophylactic Donor Lymphocyte Infusion (DLI) Followed by Minimal Residual Disease and Graft-versus-Host Disease-Guided Multiple DLIs Could Improve Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Refractory/Relapsed Acute Leukemia. Biol Blood Marrow Transplant. 2017 Aug;23(8):1311-1319. doi: 10.1016/j.bbmt.2017.04.028. Epub 2017 May 5.
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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.
XiaoJun Huang, M.D. principal investigator
Peking University People's Hospital，Institute of Hematology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic GPBPCI in people with Leukemia, run by Peking University People's Hospital at 6 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (time frame: one year after HSCT). 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 NCT01455272, which also lists 3 linked publications.
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 7 Apr 2015.