Indolent Non Hodgkin's Lymphoma (iNHL)NADIRNCT02273856
Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)
An observational study of Indolent Non Hodgkin's Lymphoma (iNHL) and Chronic Lymphocytic Leukaemia (CLL), run by Astellas Pharma International B.V. at 8 sites in 7 countries.
Trial summary
The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non Hodgkin's Lymphoma (iNHL), Chronic Lymphocytic Leukaemia (CLL)
- How many people
- 25 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Jan 2015to Aug 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are from the MENA region, and will be selected from sites that are considered clinical centres of excellence in the region.
Who may be able to join
- Informed consent
- CLL patients or
- iNHL patients
- Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")
Who cannot join
- Patient deemed unfit for enrollment by the documented opinion of the investigator
- Watch and wait patients
- Richter's transformation
- Patients otherwise not eligible for (pharmacological) intervention
- Moribund patients
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Lebanon2 sites
Site Hammoud Hospital University Medical Center
Beirut, Beirut, 1600
Site Hotel Dieu De France
Beirut, Beirut, 166830
Jordan1 site
Site JO96201 King Abdullah University Hospital
Irbid, Irbid Governorate, 22110
Kuwait1 site
Site KW96501 Kuwait Cancer Control Center
Ash Shuwaykh, Shuwaikh, 70653
Oman1 site
Site OM96801 Sultan Qaboos University Hospital
Muscat, Muḩāfaz̧at Masqaţ, 123
Qatar1 site
Site Hamad Medical Coorporation, National Center for Cancer Care and Research, Al Amal Hospital
Doha, Baladiyat ad Dawhah, 3050
Saudi Arabia1 site
Site SA96601 Aseer Central Hospital
Abhā, 'Asir Region, 61421
United Arab Emirates1 site
Site AE97101 Sheikh Khalifa Medical City
Abu Dhabi, Abu Dhabi Emirate, 51900
About this study
Official title: Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma
The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.
Read the detailed description
Patients will be followed up to 30 months.
- Keywords
- Chronic Lymphocytic Leukaemia (CLL), Indolent Non Hodgkin's Lymphoma (iNHL)
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment naïve patients with CLL | Not described | |
| Treatment naïve patients with iNHL | Not described | |
| Relapsed/refractory patients with CLL | Not described | |
| Relapsed/refractory patients with iNHL | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
Types of combination treatment (including but not limited to R-CHOP [rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone] , FCR [fludarabine, cyclophosphamide, rituximab], COP [cyclophosphamide, doxorubicin, prednisone], BR [bendamustine, rituximab], etc.) will be collected in treatment-naïve and relapsed patients. Data to be described as percentage of patients on each regimen.
Measured: Baseline, 1 year and 2 years after baseline (up to 30 months)
Secondary outcomes (15)
Duration of response
Measured: up to 30 months
Overall survival
Measured: up to 30 months
Progression free survival
Measured: up to 30 months
Number of subjects in complete remission
Measured: up to 30 months
Number of subjects in partial remission
Measured: up to 30 months
Disease type and staging
Measured: up to 30 months
Clinical responses
Relapses, response or non-response to treatment
Measured: up to 30 months
Safety as assessed by adverse events
Measured: up to 30 months
CLL specific variable: Histology
Proportion of different subtypes in CLL: (1) histologically indolent CLL (HIC), defined as morphologically typical CLL with no histologic features of progression or transformation such as increased large cells, large confluent proliferation centers, or high proliferation rate; (2) CLL with histological features of intermediate aggressiveness histologically aggressive CLL [HAC]) (3) Richter's syndrome. Data to be described as percentage.
Measured: up to 30 months
iNHL specific variables: Histology
Proportion of different subtypes in iNHL will be presented. Data to be described as percentage.
Measured: up to 30 months
Health-related quality of life variables
Using EQ-5D questionnaire, including a visual analog scale (dimensions): mobility, self-care, usual activities, pain/discomfort, anxiety/depression
Measured: up to 30 months
CLL specific variable: Rai/Binet staging systems
Percentage of patients in the different stages.
Measured: up to 30 months
CLL specific variable: Clinically relevant biomarker status
Includes immunoglobulin heavy chain variable (IgHV) status, ZAP-70 (70-kDa zeta-associated protein), receptor status (including CD20), cytogenetics (6q, 11q, 13q, and 17p deletion or monosomy, trisomy 12 ). Percentages will be presented for the clinically relevant biomarker status.
Measured: up to 30 months
iNHL specific variables: Ann Arbor staging classification
Percentage of patients in the different stages.
Measured: up to 30 months
iNHL specific variables: Clinically relevant biomarker status
Includes receptor status (including CD20). Percentages will be presented for the clinically relevant biomarker status.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: The study was terminated due to insufficient subject enrollment and very slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent Non Hodgkin's Lymphoma (iNHL)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma International B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273856
- Sponsor's protocol ID
- ONC-MA-1002
- Acronym
- NADIR
- Status last verified
- May 2016
- First submitted
- 2 Sep 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Observational Registry Of Treatments And Outcomes In Patients With Chronic Lymphocytic Leukaemia Or Indolent Non Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT02273856
- Acronym / sponsor ID
- NADIR / ONC-MA-1002
- Keywords
- Chronic Lymphocytic Leukaemia (CLL), Indolent Non Hodgkin's Lymphoma (iNHL)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to insufficient subject enrollment and very slow enrollment.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Astellas Pharma International B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Oct 2014 (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 purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.
Detailed description
Patients will be followed up to 30 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment naïve patients with CLL | – | – |
| Treatment naïve patients with iNHL | – | – |
| Relapsed/refractory patients with CLL | – | – |
| Relapsed/refractory patients with iNHL | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are from the MENA region, and will be selected from sites that are considered clinical centres of excellence in the region.
Key inclusion criteria (4 listed)
- Informed consent
- CLL patients or
- iNHL patients
- Clinical decision made to initiate or adapt treatment of CLL/iNHL("Need to treat")
Key exclusion criteria (5 listed)
- Patient deemed unfit for enrollment by the documented opinion of the investigator
- Watch and wait patients
- Richter's transformation
- Patients otherwise not eligible for (pharmacological) intervention
- Moribund patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL)
Time frame: Baseline, 1 year and 2 years after baseline (up to 30 months)
Types of combination treatment (including but not limited to R-CHOP [rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone] , FCR [fludarabine, cyclophosphamide, rituximab], COP [cyclophosphamide, doxorubicin, prednisone], BR [bendamustine, rituximab], etc.) will be collected in treatment-naïve and relapsed patients. Data to be described as percentage of patients on each regimen.
15 secondary outcomes
Duration of response
Time frame: up to 30 months
Overall survival
Time frame: up to 30 months
Progression free survival
Time frame: up to 30 months
Number of subjects in complete remission
Time frame: up to 30 months
Number of subjects in partial remission
Time frame: up to 30 months
Disease type and staging
Time frame: up to 30 months
Clinical responses
Time frame: up to 30 months
Safety as assessed by adverse events
Time frame: up to 30 months
CLL specific variable: Histology
Time frame: up to 30 months
iNHL specific variables: Histology
Time frame: up to 30 months
Health-related quality of life variables
Time frame: up to 30 months
CLL specific variable: Rai/Binet staging systems
Time frame: up to 30 months
CLL specific variable: Clinically relevant biomarker status
Time frame: up to 30 months
iNHL specific variables: Ann Arbor staging classification
Time frame: up to 30 months
iNHL specific variables: Clinically relevant biomarker status
Time frame: up to 30 months
Results and safety
The study was stopped early (reason given: The study was terminated due to insufficient subject enrollment and very slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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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.
Medical Director study director
Astellas Pharma International B.V.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indolent Non Hodgkin's Lymphoma (iNHL) and Chronic Lymphocytic Leukaemia (CLL), run by Astellas Pharma International B.V. at 8 sites in 7 countries.
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 4 inclusion and 5 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Lebanon, Jordan, Kuwait, Oman, Qatar and 2 more countries. 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 study was terminated due to insufficient subject enrollment and very slow enrollment.). 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?
Proportion of patients on different types of pharmacological regimen for treatment of Chronic Lymphocytic Leukaemia (CLL) or Indolent Non Hodgkin's Lymphoma (iNHL) (time frame: Baseline, 1 year and 2 years after baseline (up to 30 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 21 Jun 2016.