Chronic Myeloid LeukemiaNCT03062436
To Study the Impact of Stopping Therapy in Patients of CML With Molecular Remission
A study testing Stopping the standard drug therpy and Quantitative bcrabl recording every month for first 6 months in people with Chronic Myeloid Leukemia and Treatment Free Remission, run by Command Hospital, India at 1 site in India.
Trial summary
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Chronic Myeloid Leukemia, Treatment Free Remission
- What is being tested?
- Stopping the standard drug therpy and Quantitative bcrabl recording every month for first 6 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2017to Dec 2020
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of CML on TKI (Imatinib) therapy for more than 5 years
- Patients who have been in complete molecular response (MR 4.5 +) for at least three years
Who cannot join
- Patients who ever had blast crisis
- Patients achieving molecular response with second generation TKI due to failure of Imatinib
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.
Read the detailed description
While a large number of studies which have stopped TKI therapy in similar patients exist in Europe and USA, no such study has been done on Indian or other south Asian population. Almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their TKI therapy, their remission state is regained once the TKI therapy is restarted.
- Conditions
- Chronic Myeloid Leukemia, Treatment Free Remission
- Being tested
- Stopping the standard drug therpy, Quantitative bcrabl recording every month for first 6 months
- Keywords
- CML, treatment free remission
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stopping the standard drug therpyOther
Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status
Quantitative bcrabl recording every month for first 6 monthsDiagnostic test
Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5
| Study group | Role | What they receive |
|---|---|---|
| Sustained molecular remission | Experimental | Patients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy Receives: Other: Stopping the standard drug therpy; Diagnostic Test: Quantitative bcrabl recording every month for first 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Recurrence
Re-appearance of bcr-abl transcripts by RQPCR at a level >0.01%
Measured: 12 months from cessation of the drug therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Command Hospital, India
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sanjeevan Sharma, Command Hospital, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062436
- Sponsor's protocol ID
- AFMRC 4714/2016
- Status last verified
- Jul 2019
- First submitted
- 20 Feb 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping Imatinib Therapy in CML Patients With Sustained Molecular Remission
- ClinicalTrials.gov ID
- NCT03062436
- Acronym / sponsor ID
- AFMRC 4714/2016
- Conditions
- Chronic Myeloid Leukemia, Treatment Free Remission
- Keywords
- CML, treatment free remission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Command Hospital, IndiaOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
Patients with chronic myeloid leukemia (CML) are conventionally put on life long therapy with tyrosine kinase inhibitor drugs (Imatinib mesylate in India). Patients who achieve a deep molecular response which has been sustained for at least three years, can be taken off the drug therapy. Thereafter a close monitoring is required to monitor their disease relapse. In case there is evidence of disease recurrence on highly sensitive molecular assays, their drug therapy is restarted. The study aims to identify proportion of patients who can be kept off drug therapy in a state of sustained molecular remission.
Detailed description
While a large number of studies which have stopped TKI therapy in similar patients exist in Europe and USA, no such study has been done on Indian or other south Asian population. Almost all studies done previously have noted that in relapsed patients, who show disease recurrence on stopping their TKI therapy, their remission state is regained once the TKI therapy is restarted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sustained molecular remission | Experimental | Other: Stopping the standard drug therpy, Diagnostic Test: Quantitative bcrabl recording every month for first 6 monthsPatients of CML who remain in sustained molecular remission at 12 months after Stopping the standard drug therapy |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of CML on TKI (Imatinib) therapy for more than 5 years
- Patients who have been in complete molecular response (MR 4.5 +) for at least three years
Key exclusion criteria (2 listed)
- Patients who ever had blast crisis
- Patients achieving molecular response with second generation TKI due to failure of Imatinib
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 |
|---|---|---|
| Stopping the standard drug therpyStopping the standard drug therapy of CML patients and monitoring their treatment free remission status | Other | Sustained molecular remission |
| Quantitative bcrabl recording every month for first 6 monthsMonthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5 | Diagnostic test | Sustained molecular remission |
Primary outcome
Disease Recurrence
Time frame: 12 months from cessation of the drug therapy
Re-appearance of bcr-abl transcripts by RQPCR at a level >0.01%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stopping the standard drug therpy and Quantitative bcrabl recording every month for first 6 months in people with Chronic Myeloid Leukemia and Treatment Free Remission, run by Command Hospital, India 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 2 inclusion and 2 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 23 Jul 2019. 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.
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?
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?
Disease Recurrence (time frame: 12 months from cessation of the drug therapy). 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 23 Jul 2019.