Myelodysplastic SyndromesPhase 2CLO2009AISSM05NCT01302106
Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes
A Phase 2 study testing Clofarabine plus low dose Ara-C in people with Myelodysplastic Syndromes, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 21 sites in Italy.
Trial summary
This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Clofarabine plus low dose Ara-C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 21 sitesItaly
- Study dates
- Start not givento not given
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age 55 to 80 years
- Written informed consent to participate in the clinical trial
- Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
- ECOG performance status 0-2
- No previous chemotherapy
- Serum bilirubin ≤1.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
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- AST and ALT ≤2.5 times ULN
- Alkaline phosphatase ≤2.5 times ULN
- Serum creatinine ≤ 1 mg/dl: if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine) -1.154 x age in years -0-023 x 0.742 (if patient is female) x 1.212 (if patient is black)
- HIV negative
Who cannot join
- Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
- Have had a prior hematopoietic stem cell transplant for MDS
- Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
- Have had any prior treatment with Clofarabine
- Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: a.)Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease -free duration, are eligible for this study if definitive treatment for the condition has been completed. b.)Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- Have prior positive test for the Human Immunodeficiency Virus (HIV), HCV, HBV.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
SC Ematologia-AO SS.Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Dipartimento Scienze Mediche e Chirurgiche-Ospedale di Torrette
Ancona, 60020
Ematologia con trapianto-AO Policlinico Bari
Bari, 70124
SC di Ematologia-Spedali Civili
Brescia, 25123
centro di ricerca e di formazione ad alta tecnologia nelle Scienze-Università Cattolica Campobasso
Campobasso, 86100
Ematologia e Trapianto di Midollo Osseo-Ospedale Ferrarotto Alessi
Catania, 95123
Dipartimento di medicina Interna-Università di genova
Genova, 16132
UO Ematologia Vito Fazzi
Lecce, 73100
SC Ematologia-Azienda Ospedaliero Papardo
Messina, 98158
UO Ematologia-Ospedale San gennaro-ASL1
Naples, 80131
Divisione di Ematologia e Trapianto Cellule Staminali-Ospedale A.Cardelli
Naples
Medicina interna II- Azienda Ospedaliera S.Luigi Gonzaga
Orbassano, 10043
Divisione di Ematologia-Ospedale Vincenzo Cervello
Palermo, 90146
Dipartimento di Ematologia-Ospedale Spirito Santo Pescara
Pescara, 65100
Divisione di Ematologia- Azienda Ospedaliera Pisana Ospedale "S.Chiara"
Pisa, 56100
Divisione Ematologia- AO Bianchi Melacrino Morelli
Reggio Calabria, 89100
UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, 85028
Ematologia-Azienda Ospedaliera Sant'Andrea
Roma, 00189
Divisione di Ematologia, Centro Trapianto di cellule staminali-IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, 71013
UO Ematologia 2-Ospedale San Giovanni Battista
Torino, 10126
Divisione di Ematologia-Ospedale Cardinale Panico
Tricase, 73039
About this study
Official title: Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes
This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Clofarabine plus low dose Ara-C
- Keywords
- Myelodysplastic Syndromes, Clofarabine, Low Dose Cytarabine, Poor risk MDS
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clofarabine plus low dose Ara-CDrug
Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Clofarabine combined with low dose Ara-C Receives: Drug: Clofarabine plus low dose Ara-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the remission rate according to the combination regimen
Measured: 19 months
Secondary outcomes (4)
Duration of response and survival
Measured: 19 months
Time to transformation in AML
Measured: 19 months
To determine the relationship of cytogenetic abnormalities and response to treatment
Measured: 19 months
To determine the safety and tolerability of the combination regimen
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
Why it stopped: For increased induction mortality in older patients due to specific combinations of drugs, other clinical factors such as patient age and comorbidities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felicetto Ferrara, MD, Study chair, Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302106
- Sponsor's protocol ID
- CLO2009AISSM05
- Other IDs
- EudraCT number 2009-012755-23
- Acronym
- CLO2009AISSM05
- Status last verified
- Sep 2013
- First submitted
- 22 Dec 2010
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01302106
- Acronym / sponsor ID
- CLO2009AISSM05 / CLO2009AISSM05
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic Syndromes, Clofarabine, Low Dose Cytarabine, Poor risk MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: For increased induction mortality in older patients due to specific combinations of drugs, other clinical factors such as patient age and comorbidities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETSUniversity, hospital or other
- First posted
- 23 Feb 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.
This is an interventional, multicenter, open label, phase II study designed to evaluate the safety and efficacy of Clofarabine in combination with low dose Cytarabine in untreated patients with poor risk of Myelodisplastic Syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Clofarabine plus low dose Ara-CClofarabine combined with low dose Ara-C |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients age 55 to 80 years
- Written informed consent to participate in the clinical trial
- Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
- ECOG performance status 0-2
- No previous chemotherapy
Key exclusion criteria (8 listed)
- Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
- Have had a prior hematopoietic stem cell transplant for MDS
- Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
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 plus low dose Ara-CClofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C. | Drug | Arm 1 |
Primary outcome
To assess the remission rate according to the combination regimen
Time frame: 19 months
4 secondary outcomes
Duration of response and survival
Time frame: 19 months
Time to transformation in AML
Time frame: 19 months
To determine the relationship of cytogenetic abnormalities and response to treatment
Time frame: 19 months
To determine the safety and tolerability of the combination regimen
Time frame: 19 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
Related trials for Myelodysplastic Syndromes
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Felicetto Ferrara, MD study chair
Division of Hematology and Stem Cell Transplantation Unit, Ospedale "A.Cardarelli", Napoli, Italy
21 sites 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 plus low dose Ara-C in people with Myelodysplastic Syndromes, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 21 sites in Italy.
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 10 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
To assess the remission rate according to the combination regimen (time frame: 19 months). 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 1 Oct 2013.