| CTRI Number |
CTRI/2021/11/038192 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study to describe disease characteristics, treatment patterns, treatment-related outcomes for Chronic Lymphocytic Leukemia (CLL) patients. |
|
Scientific Title of Study
|
A Multicenter Retrospective Study to
understand the clinical
characteristics, treatment pathway and resource utilization
for patients with chronic lymphocytic leukemia. |
| Trial Acronym |
CREEK Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D8220R00031 Version 2.0 27 January 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhausaheb Bagal |
| Designation |
Professor and Consultant Medical Oncology |
| Affiliation |
Tata Memorial Hospital Mumbai |
| Address |
Tata Memorial Hospital Hemato-Oncology
Dr E Borges Road Parel Mumbai 400012
Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
bagalbp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HS Drupad |
| Designation |
Medical Affairs Manager |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor
Manyata Embassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
AstraZeneca Pharma India Ltd Block N1 12th Floor
Manyata Embassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
drupad.hs@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Amit Kumar |
| Designation |
Project Delivery Lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor
Manyata Embassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
AstraZeneca Pharma India Ltd Block N1 12th Floor
Manyata Embassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd Block N1 12th Floor
Manyata Embassy Business Park Rachenahalli Outer Ring Road
Bangalore 560045 |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore-560045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Mehta |
Asian Institute of Medical Sciences |
"Asian Institute of Medical Sciences,
Badkal Flyover, Sector - 21A,
Faridabad, Haryana - 121001"
Faridabad
HARYANA |
9599460474
prashantcipher7@gmail.com |
| Dr Sajjan Rajpurohit |
Dr. BL Kapur Memorial Hospital |
"Dr. BL Kapur Memorial Hospital,
Director - Medical Oncology, 1st floor,
OPD-7, Oncology Department,
Pusa Road, New Delhi - 110005"
New Delhi
DELHI |
9999660200
sajjanrajpurohit@yahoo.com |
| Dr Rahul Bhargava |
Fortis Memorial Research Institute |
"Fortis Memorial Research Institute,
Director Hematology, BMT Department, Lower Ground Floor,
Sector-44, Opp Huda city Metro station,
Gurugram, Haryana - 122002"
Gurgaon
HARYANA |
9958174994
bhargava777@gmail.com |
| Dr Bhavin Shah |
Hemato Oncology Clinic Vedanta Institute of Medical Sciences |
Vedanta Institute of Medical Sciences
Hemato Oncology Clinic
1st Floor
Navrangpura Ahmedabad
Gujarat - 380009
Ahmadabad
GUJARAT |
9825327101
dr_bhavin@hotmail.com |
| Dr Ashish Dixit |
Manipal Hospital |
"
Manipal Hospital,
Dept of Oncology, 1st floor,
98, HAL Airport Road,
Bangalore – 560 017
Karnataka "
Bangalore
KARNATAKA |
9845217521
adxt001@gmail.com |
| Dr Rahul Nathani |
Max Super Speciality Hospital |
"Max Super Speciality Hospital,
Oncology OPD, 1st floor, East Block, Road no. 2, Saket,
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket,
New Delhi - 110017 "
New Delhi
DELHI |
8800175901
Dr_rahul6@hotmail.com |
| Dr Vivek Agarwala |
Narayana Super Speciality Hospital |
Narayana Super Speciality Hospital, 120/1, Andul Road, Howrah - 711103
Haora
WEST BENGAL |
8879222875
drvivekagarwala@gmail.com |
| Dr Syed Nisar Ahmed |
Sher-I-Kashmir Institute of Medical Sciences |
Sher-I-Kashmir Institute of Medical Sciences, Soura, Srinagar South, Jammu and Kashmir (State) 190011
Srinagar
JAMMU & KASHMIR |
9469664186
syednisar76@yahoo.co.in |
| Dr Bhausaheb Bagal |
Tata Memorial Hospital |
"Tata Memorial Hospital,
Hemato-Oncology Dept,
Dr. E. Borges Road, Parel, Mumbai – 400012
Maharashtra"
Mumbai
MAHARASHTRA |
9930428999
bagalbp@gmail.com |
| Dr Ganesh Jaishetwar |
Yashoda Hospital |
"
Yashoda Hospital,
Sr. Consultant, Haemologist room no. 237, 2nd floor, Block-A,
Raj Bhavan Rd, Matha Nagar, Somajiguda,
Telangana – 500082
Hyderabad"
Hyderabad
TELANGANA |
9849388806
ganeshjaishetwar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Dr. BL Kapur Memorial Hospital Ethics Committee, |
Approved |
| Ethics Committee of Care Institute of Medical Sciences |
Approved |
| Ethics Committee Of Manipal Hospitals |
Approved |
| Institutional Ethics Committee Devki Devi Foundation |
Approved |
| Institutional Ethics Committee Asian Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Fortis Memorial Research Institute |
Approved |
| Institutional Ethics Committee Sher-I-Kashmir Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Tata Memorial Centre Advanced Centre for Treatment, Research & Education in Cancer Mumbai |
Approved |
| Institutional Ethics Committee Yashoda Hospital |
Approved |
| NSH Ethics Committee, Narayana Super Speciality Hospital, 120/1, Andul Road, Howrah - 711103 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C919||Lymphoid leukemia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)
2. Initiated CLL treatment (including 1st line 2nd line or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection
For GCC pilot cohort patients: treatment naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection
3. Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation)
4. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry unless a waiver was granted) according to local regulations
5. Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations) |
|
| ExclusionCriteria |
| Details |
1. Failure to meet one or more of the inclusion criteria.
2. Any diagnosis of B cell malignancies other than CLL.
3. Current or prior use of acalabrutinib treatment.
4. Currently previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Recording patient characteristics.
(2) Recording disease characteristics. |
one-time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (1) Recording the treatment patterns. (2) Recording the treatment-related outcomes. |
one-time |
|
|
Target Sample Size
|
Total Sample Size="1250"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "1045"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/12/2021 |
| Date of Study Completion (India) |
31/01/2024 |
| Date of First Enrollment (Global) |
30/11/2021 |
| Date of Study Completion (Global) |
31/01/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective, observational, registry-based study including patients with a diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) data for a given patient will be collected during a one-time summary of medical records and will include at least one year of the patient’s data. |