LeukemiaPhase 2NCT01501708
Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
A Phase 2 study testing Caspofugin based combination therapy in people with Leukemia and Transplantation, Hematopoietic Stem Cell, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Leukemia, Transplantation, Hematopoietic Stem Cell
- What is being tested?
- Caspofugin based combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2017
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patient undergoing allogeneic hematopoietic stem cell transplantation
- age 18-55 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
- proven or probable IFI
Who cannot join
- age less than 18 years or over 56 years
- HLA mismatched related donor
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025
Ling Wang, M.D, 86-21-64370045 ext. 601818
About this study
Official title: Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.
Read the detailed description
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection
- Conditions
- Leukemia, Transplantation, Hematopoietic Stem Cell
- Being tested
- Caspofugin based combination therapy
- Keywords
- caspofungin, IFI, allogeneic hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caspofugin based combination therapyDrug
Also called caspofungin + voriconazole or amphotericin B
Caspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d.
- All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.
- In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.
| Study group | Role | What they receive |
|---|---|---|
| Caspofugin based combination therapy | Experimental | Caspofugin based combination therapy:
Patients will recieve caspofungin with voriconazole or amphotericin B Receives: Drug: Caspofugin based combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable response rate
Measured: 12 weeks
Secondary outcomes (1)
Overall survival
Measured: 12 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- 55 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
- Ling Wang, M.D., Principal investigator, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501708
- Sponsor's protocol ID
- RJH-2011-71
- Status last verified
- May 2016
- First submitted
- 26 Dec 2011
- Last updated
- 10 May 2016
- 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 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
- ClinicalTrials.gov ID
- NCT01501708
- Acronym / sponsor ID
- RJH-2011-71
- Conditions
- Leukemia, Transplantation, Hematopoietic Stem Cell
- Keywords
- caspofungin, IFI, allogeneic hematopoietic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Dec 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.
In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.
Detailed description
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caspofugin based combination therapy | Experimental | Drug: Caspofugin based combination therapyCaspofugin based combination therapy: Patients will recieve caspofungin with voriconazole or amphotericin B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- adult patient undergoing allogeneic hematopoietic stem cell transplantation
- age 18-55 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
Key exclusion criteria (4 listed)
- age less than 18 years or over 56 years
- HLA mismatched related donor
- liver function/renal function damage (over 2 X upper normal range)
- with mental 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 |
|---|---|---|
| Caspofugin based combination therapyAlso: caspofungin + voriconazole or amphotericin BCaspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d. * All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given. * In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given. | Drug | Caspofugin based combination therapy |
Primary outcome
Favorable response rate
Time frame: 12 weeks
1 secondary outcome
Overall survival
Time frame: 12 weeks, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Individual participant dataSharing planned: No
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Ling Wang, 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 Caspofugin based combination therapy in people with Leukemia and Transplantation, Hematopoietic Stem Cell, 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 6 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: status not confirmed, as of the sponsor's last update on 10 May 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 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. 601818, hujiong@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable response rate (time frame: 12 weeks). 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 10 May 2016.