Lymphoid MalignanciesPhase 2NCT01435447
Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies
A Phase 2 study testing FLu-Bu-Cy in people with Lymphoid Malignancies, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Lymphoid Malignancies
- What is being tested?
- FLu-Bu-Cy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to 1 Oct 2018
- 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
- adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
- age 16-60 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)
Who cannot join
- age less than 16 years or over 60 years
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
- other contraindication of all-HSCT
Trial locations and contacts
1 site in 1 country.
China1 site
Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation
Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.
Read the detailed description
Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.
- Conditions
- Lymphoid Malignancies
- Being tested
- FLu-Bu-Cy
- Keywords
- efficacy, safety, conditioning, fludarabine, busulfan, cyclophosphamide, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLu-Bu-CyDrug
Also called Study group
Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.
| Study group | Role | What they receive |
|---|---|---|
| FLu-Bu-Cy | Experimental | Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning Receives: Drug: FLu-Bu-Cy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute graft versus host disease (GVHD)
d100 incidence of acute GVHD, grade II-IV or grade III-IV
Measured: day 100
chronic GVHD
3-year incidence of chronic GVHD and extensive cGVHD
Measured: 3 years
Secondary outcomes (5)
non-relapse mortality (NRM)
estimated 3-year NRM after transplantation (death not due to relapse disease)
Measured: 3 years
cumulated incidence of relapse (CIR)
estimated 3-year CIR after transplantation
Measured: 3 years
event-free survival (EFS)
estimated 3-year EFS estimated 3-year EFS after transplantation
Measured: 3 years
overall survival (OS)
estimated 3-year OS after transplantation
Measured: 3 years
GVHD-free, relapse-free survival (GRFS)
estimated 3-year survival for patients without relapse, without III-IV aGVHD and without cGVHD required systemic treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startApr 2011
- Primary completion30 Jun 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid MalignanciesStudies 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
- 31 participants (actual)
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 University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435447
- Sponsor's protocol ID
- RJH-ALL-2011
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2011
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01435447
- Acronym / sponsor ID
- RJH-ALL-2011
- Conditions
- Lymphoid Malignancies
- Keywords
- efficacy, safety, conditioning, fludarabine, busulfan, cyclophosphamide, adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 16 Sep 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.
Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.
Detailed description
Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLu-Bu-Cy | Experimental | Drug: FLu-Bu-CyPatients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
- age 16-60 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)
Key exclusion criteria (4 listed)
- age less than 16 years or over 60 years
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
- other contraindication of all-HSCT
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 |
|---|---|---|
| FLu-Bu-CyAlso: Study groupFludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5. | Drug | FLu-Bu-Cy |
Primary outcome
acute graft versus host disease (GVHD)
Time frame: day 100
d100 incidence of acute GVHD, grade II-IV or grade III-IV
chronic GVHD
Time frame: 3 years
3-year incidence of chronic GVHD and extensive cGVHD
5 secondary outcomes
non-relapse mortality (NRM)
Time frame: 3 years
cumulated incidence of relapse (CIR)
Time frame: 3 years
event-free survival (EFS)
Time frame: 3 years
overall survival (OS)
Time frame: 3 years
GVHD-free, relapse-free survival (GRFS)
Time frame: 3 years
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 2 Nov 2018.
- Individual participant dataSharing planned: No
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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 University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FLu-Bu-Cy in people with Lymphoid Malignancies, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 4 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 2 Nov 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 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?
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?
acute graft versus host disease (GVHD) (time frame: day 100). 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 2 Nov 2018.