Acute Myeloid LeukemiaPhase 2NCT02686593
Clofarabine, Cytarabine and Mitoxantrone (CLAM) for Relapsed or Refractory AML
A Phase 2 study testing Clofarabine, AraC, mitoxantrone (CLAM) in people with Acute Myeloid Leukemia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Clofarabine, AraC, mitoxantrone (CLAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2016to 1 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory acute myeloid leukemia (AML) after one first-line chemotherapy regimen
- Patients aged 18 - 65 inclusively
- European Cooperative Oncology Group (ECOG) performance status of less than 2
Who cannot join
- Patients aged less than 18 or above 65
- ECOG performance status of 2 or more
- Acute promyelocytic leukaemia
- Uncontrolled active infection
- Uncontrolled arrhythmia
- Altered renal dysfunction with serum creatinine > 1.5 x ULN and/or creatinine clearance < 50 mL/min
Show all 12Show fewer
- Significant neurologic (grade > 2) or psychiatric disorder, dementia or seizures
- Clinical symptoms suggesting active central nervous system leukemia
- Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation
- Patients with known HIV, Hepatitis B or C infection or history of cirrhosis
- Patients Significant hepatic dysfunction: Direct bilirubin > 1.5 x upper limit of normal (ULN) for age; ALT or AST > 3 x upper limit of normal (ULN) for age; Lipase > 2.0 x upper limit of normal (ULN) for age
- Females of childbearing potential must have a negative pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction.
Read the detailed description
Clofarabine, a second generation purine nucleoside analog, has been evaluated in several studies in relapsed AML.[1-3] Safety and dosages of clorafabine have already been determined in previous phase I/II studies. A demonstrable complete remission rate of up to 40% to 50% was shown in relapsed or refractory AML.[4-6] Since 2009, Clofarabine (40mg/m2/day for 5 days) in combination with high-dose cytarabine (2g/m2/day for 5 days) (CLARA) was adopted as the re-induction protocol for relapsed or refractory patients with AML at the Department of Medicine, Queen Mary Hospital. We have shown that this protocol is safe, tolerable and effective for relapsed AML. A recent updated analysis (Gill H et al., unpublished) showed a completed response rate of 50.8%. With the CLARA regimen, all patients (N=60) developed grade 3/4 neutropenia and thrombocytopenia. 8% developed grade 3/4 hepatotoxicity and 40% developed febrile neutropenia with clinical sepsis. There is increasing evidence to show that clofarabine is safe and efficacious when combined with the anthracyclines idarubicin or daunorubicin.7,8 In this prospective study, we combine clofarabine and cytarabine (Ara-C) with the topoisomerase II inhibitor mitoxantrone. In this protocol, the dosages of clofarabine and cytarabine will be reduced to 30mg/m2/day and 750mg/m2/day respectively, comparable to most clinical trials. In our previous publication of experience with the use of CLARA by Tse et al and Leung et al, clofarabine at 40mg/m2/day for 5 days was combined with high-dose cytarabine at 2g/m2/day.[5,6] The regimen was shown to be safe. The combination of clofarabine with anthracyclines has been evaluated. Mathiesen at al evaluated the CIA regimen comprising clofarabine at 20mg/m2/day from day 1 to day 5, idarubicin at 10mg/m2/day from day 1 to day 3 and cytarabine at 1g/m2/day from day 1 to day 5.[7] Abbie et al investigated the regimen comprising Clofarabine at 20mg/m2/day or 25mg/m2/day for 5 days in combination with mitoxantrone and etoposide.7 Based on the clinical trials and our extensive experience with the use of CLARA, the dosages of clofarabine in CLAM was determined. With the significant reduction in the dose of cytarabine to 750mg/m2/day for 5 days in CLAM, the dose of clofarabine was chosen at 30mg/m2/day for 5 days with the aim to maintain the efficacy seen with CLARA. The aim of this combination is to maintain or improve treatment efficacy seen with a lower treatment-related toxicity via dose reduction of clofarabine and cytarabine compared to CLARA. CLAM is expected to be safe and tolerable especially when used as first salvage in patient with a ECOG performance status of 0 or 1. The regimen CLAM has been approved by the institutional review board of Queen Mary Hospital/University of Hong Kong. In a pilot study, 4 patients used the regimen. 2 patients achieved a complete remission. Cardiotoxicity was not seen. Grade 3/4 hepatotoxicity was not seen. There were no treatment-related mortality observed. CLAM was shown to be safe and with manageable toxicity profile. In addition, less myeloid toxicity is expected during consolidation as patients who achieve a remission will have better marrow reserve when compared to those at relapse. Patients will have their cardiac, liver and renal function and performance status evaluated continuously and patients with cardiac dysfunction, significantly impaired renal or liver function and ECOG performance status of 2 or above will be excluded. Thus consolidation with the same dose as with induction is expected to be safe and tolerable.
The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction. We aim to improve treatment efficacy at a more tolerable dose of clofarabine and cytarabine compared to CLARA.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Clofarabine, AraC, mitoxantrone (CLAM)
- Keywords
- Clofarabine, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clofarabine, AraC, mitoxantrone (CLAM)Drug
Also called CLAM
The combination of clofarabine, cytarabine (Ara-C) and mitoxantrone will be used in patients with AML in first relapse or after failure of first salvage
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine, AraC, mitoxantrone (CLAM) | Other | This is the single arm with the intervention using Clofarabine, AraC, Mitoxantrone Receives: Drug: Clofarabine, AraC, mitoxantrone (CLAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Remission status will be assessed on day 28 of treatment for the assessment of response rate using standard criteria
Measured: Day 28
Secondary outcomes (3)
Leukemia-free survival
This is defined as time (in months) from remission after CLAM regimen to relapse (event), death (censor), HSCT (censor) or latest follow-up (censor).
Measured: 2 years
Overall survival
This is defined as the time (in months) from recruitment to death (event) or latest follow-up (censor).
Measured: 5 years
Adverse events
Toxicity will be defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE). Data on all toxicities listed will be recorded.
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 posted19 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion31 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harinder Singh, Harry Gill, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686593
- Sponsor's protocol ID
- CLOFAL07200
- Status last verified
- May 2018
- First submitted
- 15 Feb 2016
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Faderl S, Gandhi V, Kantarjian HM. Potential role of novel nucleoside analogs in the treatment of acute myeloid leukemia. Curr Opin Hematol. 2008 Mar;15(2):101-7. doi: 10.1097/MOH.0b013e3282f46e94.
PubMed 18300755Faderl S, Ferrajoli A, Wierda W, Huang X, Verstovsek S, Ravandi F, Estrov Z, Borthakur G, Kwari M, Kantarjian HM. Clofarabine combinations as acute myeloid leukemia salvage therapy. Cancer. 2008 Oct 15;113(8):2090-6. doi: 10.1002/cncr.23816.
PubMed 18756533Sampat K, Kantarjian H, Borthakur G. Clofarabine: emerging role in leukemias. Expert Opin Investig Drugs. 2009 Oct;18(10):1559-64. doi: 10.1517/13543780903173222.
PubMed 19715446Becker PS, Kantarjian HM, Appelbaum FR, Petersdorf SH, Storer B, Pierce S, Shan J, Hendrie PC, Pagel JM, Shustov AR, Stirewalt DL, Faderl S, Harrington E, Estey EH. Clofarabine with high dose cytarabine and granulocyte colony-stimulating factor (G-CSF) priming for relapsed and refractory acute myeloid leukaemia. Br J Haematol. 2011 Oct;155(2):182-9. doi: 10.1111/j.1365-2141.2011.08831.x. Epub 2011 Aug 18.
PubMed 21848522Tse E, Leung AY, Sim J, Lee HK, Liu HS, Yip SF, Kwong YL. Clofarabine and high-dose cytosine arabinoside in the treatment of refractory or relapsed acute myeloid leukaemia. Ann Hematol. 2011 Nov;90(11):1277-81. doi: 10.1007/s00277-011-1223-2. Epub 2011 Apr 1.
PubMed 21455604Leung AY, Tse E, Hwang YY, Chan TS, Gill H, Chim CS, Lie AK, Kwong YL. Primary treatment of leukemia relapses after allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning second transplantation from the original donor. Am J Hematol. 2013 Jun;88(6):485-91. doi: 10.1002/ajh.23439. Epub 2013 May 2.
PubMed 23512868Nazha A, Kantarjian H, Ravandi F, Huang X, Choi S, Garcia-Manero G, Jabbour E, Borthakur G, Kadia T, Konopleva M, Cortes J, Ferrajoli A, Kornblau S, Daver N, Pemmaraju N, Andreeff M, Estrov Z, Du M, Brandt M, Faderl S. Clofarabine, idarubicin, and cytarabine (CIA) as frontline therapy for patients </=60 years with newly diagnosed acute myeloid leukemia. Am J Hematol. 2013 Nov;88(11):961-6. doi: 10.1002/ajh.23544. Epub 2013 Sep 9.
PubMed 23877926Vigil CE, Tan W, Deeb G, Sait SN, Block AW, Starostik P, Griffiths EA, Thompson JE, Greene JD, Ford LA, Wang ES, Wetzler M. Phase II trial of clofarabine and daunorubicin as induction therapy for acute myeloid leukemia patients greater than or equal to 60 years of age. Leuk Res. 2013 Nov;37(11):1468-71. doi: 10.1016/j.leukres.2013.07.036. Epub 2013 Aug 15.
PubMed 24011826Abbi KK, Rybka W, Ehmann WC, Claxton DF. Phase I/II study of clofarabine, etoposide, and mitoxantrone in patients with refractory or relapsed acute leukemia. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):41-6. doi: 10.1016/j.clml.2014.06.005. Epub 2014 Jun 11.
PubMed 25085441Gill H, Yim R, Pang HH, Lee P, Chan TSY, Hwang YY, Leung GMK, Ip HW, Leung RYY, Yip SF, Kho B, Lee HKK, Mak V, Chan CC, Lau JSM, Lau CK, Lin SY, Wong RSM, Li W, Ma ESK, Li J, Panagiotou G, Sim JPY, Lie AKW, Kwong YL. Clofarabine, cytarabine, and mitoxantrone in refractory/relapsed acute myeloid leukemia: High response rates and effective bridge to allogeneic hematopoietic stem cell transplantation. Cancer Med. 2020 May;9(10):3371-3382. doi: 10.1002/cam4.2865. Epub 2020 Mar 18.
PubMed 32187883
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine, Cytarabine and Mitoxantrone (CLAM) for Relapsed or Refractory AML
- ClinicalTrials.gov ID
- NCT02686593
- Acronym / sponsor ID
- CLOFAL07200
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Clofarabine, Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Feb 2016 (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 study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction.
Detailed description
Clofarabine, a second generation purine nucleoside analog, has been evaluated in several studies in relapsed AML.[1-3] Safety and dosages of clorafabine have already been determined in previous phase I/II studies. A demonstrable complete remission rate of up to 40% to 50% was shown in relapsed or refractory AML.[4-6] Since 2009, Clofarabine (40mg/m2/day for 5 days) in combination with high-dose cytarabine (2g/m2/day for 5 days) (CLARA) was adopted as the re-induction protocol for relapsed or refractory patients with AML at the Department of Medicine, Queen Mary Hospital. We have shown that this protocol is safe, tolerable and effective for relapsed AML. A recent updated analysis (Gill H et al., unpublished) showed a completed response rate of 50.8%. With the CLARA regimen, all patients (N=60) developed grade 3/4 neutropenia and thrombocytopenia. 8% developed grade 3/4 hepatotoxicity and 40% developed febrile neutropenia with clinical sepsis. There is increasing evidence to show that clofarabine is safe and efficacious when combined with the anthracyclines idarubicin or daunorubicin.7,8 In this prospective study, we combine clofarabine and cytarabine (Ara-C) with the topoisomerase II inhibitor mitoxantrone. In this protocol, the dosages of clofarabine and cytarabine will be reduced to 30mg/m2/day and 750mg/m2/day respectively, comparable to most clinical trials. In our previous publication of experience with the use of CLARA by Tse et al and Leung et al, clofarabine at 40mg/m2/day for 5 days was combined with high-dose cytarabine at 2g/m2/day.[5,6] The regimen was shown to be safe. The combination of clofarabine with anthracyclines has been evaluated. Mathiesen at al evaluated the CIA regimen comprising clofarabine at 20mg/m2/day from day 1 to day 5, idarubicin at 10mg/m2/day from day 1 to day 3 and cytarabine at 1g/m2/day from day 1 to day 5.[7] Abbie et al investigated the regimen comprising Clofarabine at 20mg/m2/day or 25mg/m2/day for 5 days in combination with mitoxantrone and etoposide.7 Based on the clinical trials and our extensive experience with the use of CLARA, the dosages of clofarabine in CLAM was determined. With the significant reduction in the dose of cytarabine to 750mg/m2/day for 5 days in CLAM, the dose of clofarabine was chosen at 30mg/m2/day for 5 days with the aim to maintain the efficacy seen with CLARA. The aim of this combination is to maintain or improve treatment efficacy seen with a lower treatment-related toxicity via dose reduction of clofarabine and cytarabine compared to CLARA. CLAM is expected to be safe and tolerable especially when used as first salvage in patient with a ECOG performance status of 0 or 1. The regimen CLAM has been approved by the institutional review board of Queen Mary Hospital/University of Hong Kong. In a pilot study, 4 patients used the regimen. 2 patients achieved a complete remission. Cardiotoxicity was not seen. Grade 3/4 hepatotoxicity was not seen. There were no treatment-related mortality observed. CLAM was shown to be safe and with manageable toxicity profile. In addition, less myeloid toxicity is expected during consolidation as patients who achieve a remission will have better marrow reserve when compared to those at relapse. Patients will have their cardiac, liver and renal function and performance status evaluated continuously and patients with cardiac dysfunction, significantly impaired renal or liver function and ECOG performance status of 2 or above will be excluded. Thus consolidation with the same dose as with induction is expected to be safe and tolerable.
The study aims to evaluate the efficacy of the regimen CLAM in relapsed or refractory AML when used as first salvage for patients to relapse or fail after standard treatment with daunorubicin/cytarabine induction. We aim to improve treatment efficacy at a more tolerable dose of clofarabine and cytarabine compared to CLARA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine, AraC, mitoxantrone (CLAM) | Other | Drug: Clofarabine, AraC, mitoxantrone (CLAM)This is the single arm with the intervention using Clofarabine, AraC, Mitoxantrone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Relapsed or refractory acute myeloid leukemia (AML) after one first-line chemotherapy regimen
- Patients aged 18 - 65 inclusively
- European Cooperative Oncology Group (ECOG) performance status of less than 2
Key exclusion criteria (12 listed)
- Patients aged less than 18 or above 65
- ECOG performance status of 2 or more
- Acute promyelocytic leukaemia
- Uncontrolled active infection
- Uncontrolled arrhythmia
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 |
|---|---|---|
| Clofarabine, AraC, mitoxantrone (CLAM)Also: CLAMThe combination of clofarabine, cytarabine (Ara-C) and mitoxantrone will be used in patients with AML in first relapse or after failure of first salvage | Drug | Clofarabine, AraC, mitoxantrone (CLAM) |
Primary outcome
Response rate
Time frame: Day 28
Remission status will be assessed on day 28 of treatment for the assessment of response rate using standard criteria
3 secondary outcomes
Leukemia-free survival
Time frame: 2 years
Overall survival
Time frame: 5 years
Adverse events
Time frame: 1 year
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 6 Oct 2022.
- Background: PubMed 18300755Faderl S, Gandhi V, Kantarjian HM. Potential role of novel nucleoside analogs in the treatment of acute myeloid leukemia. Curr Opin Hematol. 2008 Mar;15(2):101-7. doi: 10.1097/MOH.0b013e3282f46e94.
- Background: PubMed 18756533Faderl S, Ferrajoli A, Wierda W, Huang X, Verstovsek S, Ravandi F, Estrov Z, Borthakur G, Kwari M, Kantarjian HM. Clofarabine combinations as acute myeloid leukemia salvage therapy. Cancer. 2008 Oct 15;113(8):2090-6. doi: 10.1002/cncr.23816.
- Background: PubMed 19715446Sampat K, Kantarjian H, Borthakur G. Clofarabine: emerging role in leukemias. Expert Opin Investig Drugs. 2009 Oct;18(10):1559-64. doi: 10.1517/13543780903173222.
- Background: PubMed 21848522Becker PS, Kantarjian HM, Appelbaum FR, Petersdorf SH, Storer B, Pierce S, Shan J, Hendrie PC, Pagel JM, Shustov AR, Stirewalt DL, Faderl S, Harrington E, Estey EH. Clofarabine with high dose cytarabine and granulocyte colony-stimulating factor (G-CSF) priming for relapsed and refractory acute myeloid leukaemia. Br J Haematol. 2011 Oct;155(2):182-9. doi: 10.1111/j.1365-2141.2011.08831.x. Epub 2011 Aug 18.
- Background: PubMed 21455604Tse E, Leung AY, Sim J, Lee HK, Liu HS, Yip SF, Kwong YL. Clofarabine and high-dose cytosine arabinoside in the treatment of refractory or relapsed acute myeloid leukaemia. Ann Hematol. 2011 Nov;90(11):1277-81. doi: 10.1007/s00277-011-1223-2. Epub 2011 Apr 1.
- Background: PubMed 23512868Leung AY, Tse E, Hwang YY, Chan TS, Gill H, Chim CS, Lie AK, Kwong YL. Primary treatment of leukemia relapses after allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning second transplantation from the original donor. Am J Hematol. 2013 Jun;88(6):485-91. doi: 10.1002/ajh.23439. Epub 2013 May 2.
- Background: PubMed 23877926Nazha A, Kantarjian H, Ravandi F, Huang X, Choi S, Garcia-Manero G, Jabbour E, Borthakur G, Kadia T, Konopleva M, Cortes J, Ferrajoli A, Kornblau S, Daver N, Pemmaraju N, Andreeff M, Estrov Z, Du M, Brandt M, Faderl S. Clofarabine, idarubicin, and cytarabine (CIA) as frontline therapy for patients </=60 years with newly diagnosed acute myeloid leukemia. Am J Hematol. 2013 Nov;88(11):961-6. doi: 10.1002/ajh.23544. Epub 2013 Sep 9.
- Background: PubMed 24011826Vigil CE, Tan W, Deeb G, Sait SN, Block AW, Starostik P, Griffiths EA, Thompson JE, Greene JD, Ford LA, Wang ES, Wetzler M. Phase II trial of clofarabine and daunorubicin as induction therapy for acute myeloid leukemia patients greater than or equal to 60 years of age. Leuk Res. 2013 Nov;37(11):1468-71. doi: 10.1016/j.leukres.2013.07.036. Epub 2013 Aug 15.
- Background: PubMed 25085441Abbi KK, Rybka W, Ehmann WC, Claxton DF. Phase I/II study of clofarabine, etoposide, and mitoxantrone in patients with refractory or relapsed acute leukemia. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):41-6. doi: 10.1016/j.clml.2014.06.005. Epub 2014 Jun 11.
- Derived from this study: PubMed 32187883Gill H, Yim R, Pang HH, Lee P, Chan TSY, Hwang YY, Leung GMK, Ip HW, Leung RYY, Yip SF, Kho B, Lee HKK, Mak V, Chan CC, Lau JSM, Lau CK, Lin SY, Wong RSM, Li W, Ma ESK, Li J, Panagiotou G, Sim JPY, Lie AKW, Kwong YL. Clofarabine, cytarabine, and mitoxantrone in refractory/relapsed acute myeloid leukemia: High response rates and effective bridge to allogeneic hematopoietic stem cell transplantation. Cancer Med. 2020 May;9(10):3371-3382. doi: 10.1002/cam4.2865. Epub 2020 Mar 18.
- 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.
Harinder Singh, Harry Gill, MD principal investigator
The University of Hong Kong
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 Clofarabine, AraC, mitoxantrone (CLAM) in people with Acute Myeloid Leukemia, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 12 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 6 Oct 2022. 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 Hong Kong. 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?
Response rate (time frame: Day 28). 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 NCT02686593, which also lists 10 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 6 Oct 2022.