Hemophagocytic LymphohistiocytosisHELA2012NCT01547143
Pilot Study of Etoposide-based Therapy and Hematopoietic Cell Transplantation for Hemophagocytic Lymphohistiocytosis
A study testing IST and/or alloHCT in people with Hemophagocytic Lymphohistiocytosis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol for childhood patients can improve the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis
- What is being tested?
- IST and/or alloHCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to May 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose clinical findings satisfy 5 or more criteria out of the following 8 ones
- Fever ≥ 38.5 ℃ for ≥ 7 days
- Splenomegaly ≥ 3 FB below left subcostal margin
- Cytopenias affecting ≥ 2 of 3 lineages in PB Hb < 9 g/L Platelet < 100 x 109 /L ANC < 1.0 x 109 /L
- Hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265 mg/dL, fibrinogen ≤ 1.5 g/L)
- Hemophagocytosis in BM or spleen or LN
Show all 11Show fewer
- Low or absent NK-cell activity ( according to local laboratory reference)
- Serum-ferritin ≥ 500 mcg/L
- Soluble CD25(sIL-2 receptor) ≥ 2,400 U/ml
- 18 years of age and over.
- All patients (or his/her family when the patient cannot sign the consent form because of his/her general conditions) give written informed consent according to guidelines at institution's committee on human research.
Who cannot join
- HLH from malignancy (such as lymphoma, myeloma, leukemia, and other solid tumor)
- HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical center, University of Ulsan College of Medicine
Seoul
About this study
Official title: Pilot Study of First-line Immunosuppressive Therapy Combined With Etoposide and Allogeneic Hematopoietic Cell Transplantation in Refractory/Reactivated Cases for Hemophagocytic Lymphohistiocytosis (HLH) in Adult Patients
The investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol for childhood patients can improve the outcome and decrease the toxicities. The results of this pilot study will be a base of a more-improved phase-2 protocol.
Read the detailed description
The treatment of HLH in adult patients has not been determined yet. Actually, we adopted the treatment protocol HLH2004, which was developed for pediatric HLH patients. The HLH2004 protocol, which is a potent and successful treatment for HLH, has shown some limitations in the treatment of adult HLH. First, the dose of etoposide is somewhat high for adult patients to tolerate. Second, the high incidence of opportunistic infection such as fungal, bacterial, and viral has threatened the patients. Third, more aggressive and intensive approach to adopt allogeneic hematopoietic cell transplantation will be needed earlier in adult patients. Based on these rationales, we developed a modified protocol based on HLH2004 to pit the treatment of adult HLH patients.
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Being tested
- IST and/or alloHCT
- Keywords
- Secondary hemophagocytic lymphohistiocytosis of adults
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IST and/or alloHCTDrug
Also called Etoposide, Cyclosporine: Cipol, Dexamethasone, IV gammaglobulin
- Patients will be categorized by their initial serum ferritin level.
- Mild ( ferritin<3,000 μg/L): close observation
- Moderate (ferritin: 3,000-10,000 μg/L):
- Initiation : cyclosporine 3mg/kg p.o.bid + dexamethasone 10mg/m2/d po. or i.v. (D1-3)
- continuation: cyclosporine 3mg/kg p.o. bid (D4-56) + dexamethasone 10mg/m2/d (D4-14), then tapering.
- Severe (ferritin>10,000 μg/L):
- initiation : etoposide 100mg/m2/d i.v. + cyclosporine 2mg/kg i.v. q 12hours + dexamethasone 20mg/m2/d i.v. (D1-3)
- continuation : etoposide 100mg/m2/day weekly (D15-49) + cyclosporine 2mg/kg i.v. q 12 hours? ? po. (D4-56) + dexamethasone 10mg/m2/d (D4-14), 5mg/m2/d (D15-28), 2.5mg/m2/d (D29-42), 1.25mg/m2/d (D43-56), then tapering off.
- AlloHCT for refractory or reactivated cases.
| Study group | Role | What they receive |
|---|---|---|
| IST and/or alloHCT | Experimental | Patients who are newly diagnosed as HLH by HLH-2004 criteria, excluding those with HLH owing to malignancy or rheumatic disorder. Receives: Drug: IST and/or alloHCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
Measured: 1-year
Secondary outcomes (12)
Complete response rate
Measured: 28 days
Complete response rate
Measured: 56 days
Complete response rate
Measured: 3 months
Partial response rate
Measured: 28 days
Partial response rate
Measured: 56 days
Partial response rate
Measured: 3 months
reactivation-free survival rate
Measured: 3 months
reactivation-free survival rate
Measured: 6 months
overall survival rate
Measured: 3 months
overall survival rate
Measured: 6 months
overall survival rate
Measured: 1 year
treatment-related mortality rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Hemophagocytic LymphohistiocytosisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae-Young Kim, Asan Medical Center
- Investigators
- Dae-Young Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547143
- Sponsor's protocol ID
- AMC-H-72
- Acronym
- HELA2012
- Status last verified
- Jul 2018
- First submitted
- 29 Feb 2012
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Felix FH, Leal LK, Fontenele JB. Cloak and dagger: the case for adult onset still disease and hemophagocytic lymphohistiocytosis. Rheumatol Int. 2009 Jun;29(8):973-4. doi: 10.1007/s00296-008-0825-z. Epub 2008 Dec 30.
PubMed 19115058Grom AA. Macrophage activation syndrome and reactive hemophagocytic lymphohistiocytosis: the same entities? Curr Opin Rheumatol. 2003 Sep;15(5):587-90. doi: 10.1097/00002281-200309000-00011.
PubMed 12960485Chen JH, Fleming MD, Pinkus GS, Pinkus JL, Nichols KE, Mo JQ, Perez-Atayde AR. Pathology of the liver in familial hemophagocytic lymphohistiocytosis. Am J Surg Pathol. 2010 Jun;34(6):852-67. doi: 10.1097/PAS.0b013e3181dbbb17.
PubMed 20442642Ishii E, Ohga S, Imashuku S, Yasukawa M, Tsuda H, Miura I, Yamamoto K, Horiuchi H, Takada K, Ohshima K, Nakamura S, Kinukawa N, Oshimi K, Kawa K. Nationwide survey of hemophagocytic lymphohistiocytosis in Japan. Int J Hematol. 2007 Jul;86(1):58-65. doi: 10.1532/IJH97.07012.
PubMed 17675268Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.
PubMed 16937360Filipovich AH. Hemophagocytic lymphohistiocytosis (HLH) and related disorders. Hematology Am Soc Hematol Educ Program. 2009:127-31. doi: 10.1182/asheducation-2009.1.127.
PubMed 20008190Gupta A, Tyrrell P, Valani R, Benseler S, Weitzman S, Abdelhaleem M. The role of the initial bone marrow aspirate in the diagnosis of hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2008 Sep;51(3):402-4. doi: 10.1002/pbc.21564.
PubMed 18523990Chung HJ, Park CJ, Lim JH, Jang S, Chi HS, Im HJ, Seo JJ. Establishment of a reference interval for natural killer cell activity through flow cytometry and its clinical application in the diagnosis of hemophagocytic lymphohistiocytosis. Int J Lab Hematol. 2010 Apr;32(2):239-47. doi: 10.1111/j.1751-553X.2009.01177.x. Epub 2009 Jul 15.
PubMed 19614711Allen CE, Yu X, Kozinetz CA, McClain KL. Highly elevated ferritin levels and the diagnosis of hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2008 Jun;50(6):1227-35. doi: 10.1002/pbc.21423.
PubMed 18085676Lin TF, Ferlic-Stark LL, Allen CE, Kozinetz CA, McClain KL. Rate of decline of ferritin in patients with hemophagocytic lymphohistiocytosis as a prognostic variable for mortality. Pediatr Blood Cancer. 2011 Jan;56(1):154-5. doi: 10.1002/pbc.22774.
PubMed 20842751Gholam C, Grigoriadou S, Gilmour KC, Gaspar HB. Familial haemophagocytic lymphohistiocytosis: advances in the genetic basis, diagnosis and management. Clin Exp Immunol. 2011 Mar;163(3):271-83. doi: 10.1111/j.1365-2249.2010.04302.x.
PubMed 21303357Horne A, Ramme KG, Rudd E, Zheng C, Wali Y, al-Lamki Z, Gurgey A, Yalman N, Nordenskjold M, Henter JI. Characterization of PRF1, STX11 and UNC13D genotype-phenotype correlations in familial hemophagocytic lymphohistiocytosis. Br J Haematol. 2008 Oct;143(1):75-83. doi: 10.1111/j.1365-2141.2008.07315.x. Epub 2008 Aug 15.
PubMed 18710388Marsh RA, Satake N, Biroschak J, Jacobs T, Johnson J, Jordan MB, Bleesing JJ, Filipovich AH, Zhang K. STX11 mutations and clinical phenotypes of familial hemophagocytic lymphohistiocytosis in North America. Pediatr Blood Cancer. 2010 Jul 15;55(1):134-40. doi: 10.1002/pbc.22499.
PubMed 20486178Meeths M, Entesarian M, Al-Herz W, Chiang SC, Wood SM, Al-Ateeqi W, Almazan F, Boelens JJ, Hasle H, Ifversen M, Lund B, van den Berg JM, Gustafsson B, Hjelmqvist H, Nordenskjold M, Bryceson YT, Henter JI. Spectrum of clinical presentations in familial hemophagocytic lymphohistiocytosis type 5 patients with mutations in STXBP2. Blood. 2010 Oct 14;116(15):2635-43. doi: 10.1182/blood-2010-05-282541. Epub 2010 Jun 17.
PubMed 20558610Yoon HS, Kim HJ, Yoo KH, Sung KW, Koo HH, Kang HJ, Shin HY, Ahn HS, Kim JY, Lim YT, Bae KW, Lee KO, Shin JS, Lee ST, Chung HS, Kim SH, Park CJ, Chi HS, Im HJ, Seo JJ. UNC13D is the predominant causative gene with recurrent splicing mutations in Korean patients with familial hemophagocytic lymphohistiocytosis. Haematologica. 2010 Apr;95(4):622-6. doi: 10.3324/haematol.2009.016949. Epub 2009 Dec 16.
PubMed 20015888
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of First-line Immunosuppressive Therapy Combined With Etoposide and Allogeneic Hematopoietic Cell Transplantation in Refractory/Reactivated Cases for Hemophagocytic Lymphohistiocytosis (HLH) in Adult Patients
- ClinicalTrials.gov ID
- NCT01547143
- Acronym / sponsor ID
- HELA2012 / AMC-H-72
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Keywords
- Secondary hemophagocytic lymphohistiocytosis of adults
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Mar 2012 (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 investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol for childhood patients can improve the outcome and decrease the toxicities. The results of this pilot study will be a base of a more-improved phase-2 protocol.
Detailed description
The treatment of HLH in adult patients has not been determined yet. Actually, we adopted the treatment protocol HLH2004, which was developed for pediatric HLH patients. The HLH2004 protocol, which is a potent and successful treatment for HLH, has shown some limitations in the treatment of adult HLH. First, the dose of etoposide is somewhat high for adult patients to tolerate. Second, the high incidence of opportunistic infection such as fungal, bacterial, and viral has threatened the patients. Third, more aggressive and intensive approach to adopt allogeneic hematopoietic cell transplantation will be needed earlier in adult patients. Based on these rationales, we developed a modified protocol based on HLH2004 to pit the treatment of adult HLH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IST and/or alloHCT | Experimental | Drug: IST and/or alloHCTPatients who are newly diagnosed as HLH by HLH-2004 criteria, excluding those with HLH owing to malignancy or rheumatic disorder. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients whose clinical findings satisfy 5 or more criteria out of the following 8 ones
- 18 years of age and over.
- All patients (or his/her family when the patient cannot sign the consent form because of his/her general conditions) give written informed consent according to guidelines at institution's committee on human research.
Key exclusion criteria (6 listed)
- HLH from malignancy (such as lymphoma, myeloma, leukemia, and other solid tumor)
- HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
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 |
|---|---|---|
| IST and/or alloHCTAlso: Etoposide, Cyclosporine: Cipol, Dexamethasone, IV gammaglobulin1) Patients will be categorized by their initial serum ferritin level. 1. Mild ( ferritin<3,000 μg/L): close observation 2. Moderate (ferritin: 3,000-10,000 μg/L): 1. Initiation : cyclosporine 3mg/kg p.o.bid + dexamethasone 10mg/m2/d po. or i.v. (D1-3) 2. continuation: cyclosporine 3mg/kg p.o. bid (D4-56) + dexamethasone 10mg/m2/d (D4-14), then tapering. 3. Severe (ferritin>10,000 μg/L): 1. initiation : etoposide 100mg/m2/d i.v. + cyclosporine 2mg/kg i.v. q 12hours + dexamethasone 20mg/m2/d i.v. (D1-3) 2. continuation : etoposide 100mg/m2/day weekly (D15-49) + cyclosporine 2mg/kg i.v. q 12 hours? ? po. (D4-56) + dexamethasone 10mg/m2/d (D4-14), 5mg/m2/d (D15-28), 2.5mg/m2/d (D29-42), 1.25mg/m2/d (D43-56), then tapering off. 2) AlloHCT for refractory or reactivated cases. | Drug | IST and/or alloHCT |
Primary outcome
overall survival rate
Time frame: 1-year
12 secondary outcomes
Complete response rate
Time frame: 28 days
Complete response rate
Time frame: 56 days
Complete response rate
Time frame: 3 months
Partial response rate
Time frame: 28 days
Partial response rate
Time frame: 56 days
Partial response rate
Time frame: 3 months
reactivation-free survival rate
Time frame: 3 months
reactivation-free survival rate
Time frame: 6 months
overall survival rate
Time frame: 3 months
overall survival rate
Time frame: 6 months
overall survival rate
Time frame: 1 year
treatment-related mortality rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 19115058Felix FH, Leal LK, Fontenele JB. Cloak and dagger: the case for adult onset still disease and hemophagocytic lymphohistiocytosis. Rheumatol Int. 2009 Jun;29(8):973-4. doi: 10.1007/s00296-008-0825-z. Epub 2008 Dec 30.
- Background: PubMed 12960485Grom AA. Macrophage activation syndrome and reactive hemophagocytic lymphohistiocytosis: the same entities? Curr Opin Rheumatol. 2003 Sep;15(5):587-90. doi: 10.1097/00002281-200309000-00011.
- Background: PubMed 20442642Chen JH, Fleming MD, Pinkus GS, Pinkus JL, Nichols KE, Mo JQ, Perez-Atayde AR. Pathology of the liver in familial hemophagocytic lymphohistiocytosis. Am J Surg Pathol. 2010 Jun;34(6):852-67. doi: 10.1097/PAS.0b013e3181dbbb17.
- Background: PubMed 17675268Ishii E, Ohga S, Imashuku S, Yasukawa M, Tsuda H, Miura I, Yamamoto K, Horiuchi H, Takada K, Ohshima K, Nakamura S, Kinukawa N, Oshimi K, Kawa K. Nationwide survey of hemophagocytic lymphohistiocytosis in Japan. Int J Hematol. 2007 Jul;86(1):58-65. doi: 10.1532/IJH97.07012.
- Background: PubMed 16937360Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.
- Background: PubMed 20008190Filipovich AH. Hemophagocytic lymphohistiocytosis (HLH) and related disorders. Hematology Am Soc Hematol Educ Program. 2009:127-31. doi: 10.1182/asheducation-2009.1.127.
- Background: PubMed 18523990Gupta A, Tyrrell P, Valani R, Benseler S, Weitzman S, Abdelhaleem M. The role of the initial bone marrow aspirate in the diagnosis of hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2008 Sep;51(3):402-4. doi: 10.1002/pbc.21564.
- Background: PubMed 19614711Chung HJ, Park CJ, Lim JH, Jang S, Chi HS, Im HJ, Seo JJ. Establishment of a reference interval for natural killer cell activity through flow cytometry and its clinical application in the diagnosis of hemophagocytic lymphohistiocytosis. Int J Lab Hematol. 2010 Apr;32(2):239-47. doi: 10.1111/j.1751-553X.2009.01177.x. Epub 2009 Jul 15.
- Background: PubMed 18085676Allen CE, Yu X, Kozinetz CA, McClain KL. Highly elevated ferritin levels and the diagnosis of hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2008 Jun;50(6):1227-35. doi: 10.1002/pbc.21423.
- Background: PubMed 20842751Lin TF, Ferlic-Stark LL, Allen CE, Kozinetz CA, McClain KL. Rate of decline of ferritin in patients with hemophagocytic lymphohistiocytosis as a prognostic variable for mortality. Pediatr Blood Cancer. 2011 Jan;56(1):154-5. doi: 10.1002/pbc.22774.
- Background: PubMed 21303357Gholam C, Grigoriadou S, Gilmour KC, Gaspar HB. Familial haemophagocytic lymphohistiocytosis: advances in the genetic basis, diagnosis and management. Clin Exp Immunol. 2011 Mar;163(3):271-83. doi: 10.1111/j.1365-2249.2010.04302.x.
- Background: PubMed 18710388Horne A, Ramme KG, Rudd E, Zheng C, Wali Y, al-Lamki Z, Gurgey A, Yalman N, Nordenskjold M, Henter JI. Characterization of PRF1, STX11 and UNC13D genotype-phenotype correlations in familial hemophagocytic lymphohistiocytosis. Br J Haematol. 2008 Oct;143(1):75-83. doi: 10.1111/j.1365-2141.2008.07315.x. Epub 2008 Aug 15.
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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.
Dae-Young Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IST and/or alloHCT in people with Hemophagocytic Lymphohistiocytosis, run by Asan Medical Center at 1 site in South Korea.
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 11 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: stopped early, as of the sponsor's last update on 20 Jul 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 South Korea. 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 was stopped early (reason given: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.). Results are not available in the source record.
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?
overall survival rate (time frame: 1-year). 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 NCT01547143, which also lists 47 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 20 Jul 2018.