Elastic

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.pdf]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the Elastic Trial Office.

• Protocol [.pdf]
• Patient Information Sheet [.pdf]
• Informed Consent Form [.pdf]
• GP Letter  [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.

Current

• Version Control Checklist - Investigator Site Folder v6.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v6.0 [.pdf]

Previous

• Version Control Checklist - Investigator Site Folder v4.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v3.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v2.1 [.pdf]
• Version Control Checklist - Investigator Site Folder v2.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v1.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v5.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v4.1 [.pdf]
• Version Control Checklist - Pharmacy Folder v4.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v3.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v2.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v1.0 [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Amendments (opens new page)

Guidelines

• Informed Consent Guidelines  [.pdf]
• SAE Form Completion Guidelines  [.pdf]
• Sample Collection Guidelines v1.1 [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Azacitidine SPC 17-Feb-2015 [.pdf]
• Eltrombopag SPC 15-Jan-2015 [.pdf]
• Screening Log [.pdf]

To date there are no publications for this trial.

Case Report Forms

• Registration Form[.pdf]
• Eligibility Form [.pdf]
• Baseline Form  [.pdf]
• Treatment Cyle 1-3 Form [.pdf]
• Treatment Cycle 4-6 Form  [.pdf]
• Transfusion From [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• Preganacy notification form [.pdf]

• Sample Collection Form  [.pdf]

 ALL CRFS [.zip]

• SAE Form  [.pdf]
• SAE Fax Cover Sheet  [.pdf]
• Expected SAR form [.pdf]

No current news or upcoming events

Chief Investigator

Dr Alexander Sternberg

Consultant Haematologist

Great Western Hospital NHS Foundation Trust

Marlborough Road

Swindon

SN3 6BB

Tel: 01793 605004

Fax: 01793 604292

Email: alexander.sternberg@imm.ox.ac.uk

 

Elastic Trial Office
Trial Coordinator:                             Yolande Jefferson                               
Trial Monitor:                                    Poonam Patel
Trial Management Team Leader:    Shamyla Siddique
                       

Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Telephone: +44 (0)121 415 9179
Fax:             +44 (0)121 414 6061
Email:         elastic@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)121 415 9179                        (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44 (0)121 414 6061        or  0121 414 3700

Sponsor

The trial is sponsored by the University of Birmingham.

The trial is being conducted under the auspices of the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham according to their local procedures.