Acute Myeloid LeukemiaPhase 3Ara-cNCT01615757
Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation
A Phase 3 study testing Ara-c in people with Acute Myeloid Leukemia, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The study will be conducted in the Department of Medical Oncology and Department of Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in complete remission after induction chemotherapy will be enrolled into the study and will be further randomized to the two study arms . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Ara-c
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2012to Sep 2014
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Who cannot join
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- Serum Bilirubin > 2
Show all 10Show fewer
- APML
- Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- Patients receiving reinduction with HIDAC
- Therapy related AML
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
AIIMS
Delhi, National Capital Territory of Delhi, 110001
Prashant Mehta, MD, 09013590847, prashantcipher@yahoo.co.in
Prashant Mehta, MD
About this study
Official title: Comparison of Ara-c 12 gm/m2 vs 18 gm/m2 Per Cycle for 3 Cycles Each as Consolidation in AML ; An Open Label Randomized Non-inferiority Study
The study will be conducted in the Department of Medical Oncology and Department of Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in complete remission after induction chemotherapy will be enrolled into the study and will be further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3 cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the relapse free survival and overall survival as well as time to relapse and toxicity /treatment related morbidity.
Read the detailed description
Objectives
- To compare the efficacy of two different doses of Cytarabine during consolidation therapy for newly diagnosed patients of Non APML - Acute Myeloid Leukemia who are in CR post induction
- To compare the toxicity of the two different Cytarabine doses
Primary end point
- Relapse free survival at 1 yr from randomization
- Relapse will be defined as >5 % leukemic blasts in the marrow aspirate or new extramedullary disease anytime after randomization
Secondary end points
- Overall survival
- Median time to relapse
- Toxicity- Haematological and Non -Haematological
Inclusion criteria
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Exclusion criteria
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- Serum Bilirubin > 2
- APML
- Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- Patients receiving reinduction with HIDAC
- Therapy related AML Methodology
- The period of enrollment will be from July 1, 2012 to September 30 ,2013
- Baseline information will be recorded in a preformulated proforma designed for analysis at a later date
Treatment
- Standard 3 + 7 INDUCTION with Daunomycin and Cytarabine with DNR at 60- 90 mg/m2 as per the PS and comorbidities/active infections at presentation
- Bone marrow examination - D+ 28 of induction or earlier if needed . Patients not in CR - reinduction regimen as per discretion of treating physician
- Patients in complete morphological remission ( after 1 or 2 inductions) : will receive consolidation with HIDAC and will be randomized into the two study arms after written Informed Consent: Arm A and B with 90 patients in each arm Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5 Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5 sample size
- Assuming a RFS of 60 % at 1 yr in each arm and keeping a non-inferiority margin of 20 % , Alpha at 5 % ,75 patients are required in each arm on the basis of statistical calculation.
- 15 patients added in each arm to account for losses
- Total required in each arm = 90
- ANC> 1000 , Platelet count > 1 lac required to start HIDAC
- Detailed information of the course of all the chemotherapy cycles will be recorded including-
- toxicity
- details of antimicrobials
- supportive care ( including transfusions)
- Use of growth factors
- Cytogenetic analysis using standard technique of chromosomal banding
- Molecular analysis for mutation of FLT3-ITD will be performed
- Risk stratification will be done as per guidelines
- Patients in both arms will be kept under close follow up and will be assessed with blood counts /PS , 2 monthly / or earlier as clinically indicated
Statistical Analysis
- Qualitative data will be analyzed using the Chi-square test
- Quantitative data will be compared by using t-test /Mann Whitney test
- Besides this survival analysis will be carried out.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ara-c
- Keywords
- AML, Acute Myeloid Leukemia, Cytarabine dose, Ara-c dose, Consolidation
- 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.
Ara-cDrug
Also called Cytosar, Cytarabine
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
Ara-cDrug
Also called Cytosar, Cytarabine
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose
| Study group | Role | What they receive |
|---|---|---|
| Arm B, Ara-c - 12 gm/m2 | Experimental | Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5 Receives: Drug: Ara-c |
| Arm A. Ara-c 18 gm/m2 | Active comparator | Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5 Receives: Drug: Ara-c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival at 1 yr of follow up
Measured: 1 year
Secondary outcomes (1)
Toxicity- Haematological and Non -Haematological
The following variables will be compared in the two arms to -
-Nadir blood counts,Ara c related fever ,Allergic or skin reactions,Alopecia,Diarrhea ,Stomatitis,Bleeding ,Febrile neutropenia,Infection(fungal /bacterial/viral),Liver related event,ocular toxicity,Neurologic event,Peripheral neuropathy,Cerebral/Cerebellar toxicity,Transfusions,Time to recovery of platelets,Time to recovery of neutrophils,Duration of Hospital stay,Emergency visits,Deaths,Use of growth factors
Measured: at 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Mehta, All India Institute of Medical Sciences
- Investigators
- Prashant Mehta, MD, Principal investigator, AIIMS, Delhi, IndiaVinod Raina, MD, Study chair, AIIMS, Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615757
- Sponsor's protocol ID
- AML HIDAC, AIIMS
- Acronym
- Ara-c
- Status last verified
- Sep 2012
- First submitted
- 5 Jun 2012
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ara-c 12 gm/m2 vs 18 gm/m2 Per Cycle for 3 Cycles Each as Consolidation in AML ; An Open Label Randomized Non-inferiority Study
- ClinicalTrials.gov ID
- NCT01615757
- Acronym / sponsor ID
- Ara-c / AML HIDAC, AIIMS
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Acute Myeloid Leukemia, Cytarabine dose, Ara-c dose, Consolidation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 11 Jun 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 study will be conducted in the Department of Medical Oncology and Department of Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in complete remission after induction chemotherapy will be enrolled into the study and will be further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3 cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the relapse free survival and overall survival as well as time to relapse and toxicity /treatment related morbidity.
Detailed description
Objectives
- To compare the efficacy of two different doses of Cytarabine during consolidation therapy for newly diagnosed patients of Non APML - Acute Myeloid Leukemia who are in CR post induction
- To compare the toxicity of the two different Cytarabine doses
Primary end point
- Relapse free survival at 1 yr from randomization
- Relapse will be defined as >5 % leukemic blasts in the marrow aspirate or new extramedullary disease anytime after randomization
Secondary end points
- Overall survival
- Median time to relapse
- Toxicity- Haematological and Non -Haematological
Inclusion criteria
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Exclusion criteria
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- Serum Bilirubin > 2
- APML
- Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- Patients receiving reinduction with HIDAC
- Therapy related AML Methodology
- The period of enrollment will be from July 1, 2012 to September 30 ,2013
- Baseline information will be recorded in a preformulated proforma designed for analysis at a later date
Treatment
- Standard 3 + 7 INDUCTION with Daunomycin and Cytarabine with DNR at 60- 90 mg/m2 as per the PS and comorbidities/active infections at presentation
- Bone marrow examination - D+ 28 of induction or earlier if needed . Patients not in CR - reinduction regimen as per discretion of treating physician
- Patients in complete morphological remission ( after 1 or 2 inductions) : will receive consolidation with HIDAC and will be randomized into the two study arms after written Informed Consent: Arm A and B with 90 patients in each arm Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5 Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5 sample size
- Assuming a RFS of 60 % at 1 yr in each arm and keeping a non-inferiority margin of 20 % , Alpha at 5 % ,75 patients are required in each arm on the basis of statistical calculation.
- 15 patients added in each arm to account for losses
- Total required in each arm = 90
- ANC> 1000 , Platelet count > 1 lac required to start HIDAC
- Detailed information of the course of all the chemotherapy cycles will be recorded including-
- toxicity
- details of antimicrobials
- supportive care ( including transfusions)
- Use of growth factors
- Cytogenetic analysis using standard technique of chromosomal banding
- Molecular analysis for mutation of FLT3-ITD will be performed
- Risk stratification will be done as per guidelines
- Patients in both arms will be kept under close follow up and will be assessed with blood counts /PS , 2 monthly / or earlier as clinically indicated
Statistical Analysis
- Qualitative data will be analyzed using the Chi-square test
- Quantitative data will be compared by using t-test /Mann Whitney test
- Besides this survival analysis will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B, Ara-c - 12 gm/m2 | Experimental | Drug: Ara-cArm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5 |
| Arm A. Ara-c 18 gm/m2 | Active comparator | Drug: Ara-cArm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Key exclusion criteria (10 listed)
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
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 |
|---|---|---|
| Ara-cAlso: Cytosar, CytarabineIV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose | Drug | Arm A. Ara-c 18 gm/m2 |
| Ara-cAlso: Cytosar, CytarabineIV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose | Drug | Arm B, Ara-c - 12 gm/m2 |
Primary outcome
Relapse free survival at 1 yr of follow up
Time frame: 1 year
1 secondary outcome
Toxicity- Haematological and Non -Haematological
Time frame: at 1 yr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
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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.
Prashant Mehta, MD principal investigator
AIIMS, Delhi, India
Vinod Raina, MD study chair
AIIMS, Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ara-c in people with Acute Myeloid Leukemia, run by All India Institute of Medical Sciences at 1 site in India.
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 10 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 17 Sep 2012. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Prashant Mehta, MD (09013590847, prashantcipher@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival at 1 yr of follow up (time frame: 1 year). 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 17 Sep 2012.