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FAQs

T2020-006 Tagraxofusp Study - FAQs

 

Question Categories

1.  Drug Administration

2.  Drug Preparation and Ordering

3.  Regulatory

4.  Enrollment and Eligibility

5.  Study Samples

  1. 1. Drug Administration
    1. Pre-medications:

Can you clarify the expectation for premeds if a PRN dose of acetaminophen is used to treat a fever?

Answer: acetaminophen given within 4 hours of tagraxofusp dosing for other indications may suffice as the premedication and no additional doses are required.

 

Are we still able to dose with Tag, if Tylenol was given outside of the 60-minute window?

    Answer: Yes.

 

Is diphenhydramine required as a pre-med or are alternative anti-histamines ok (e.g. cetirizine)?

Answer: Yes, equivalent anti-histamines per institutional standards are sufficient.

  1. Prophylactic Medications:

    Are -azoles prohibited?

Answer: No, but alternative antifungals (e.g. echinocandids) are encouraged to minimize hepatotoxicity. Please see protocol section 5.3.2 for further details.

  1. Intrathecal Therapy:

Does IT chemo need to be performed within 7 days of enrollment OR C1D1?

Answer: IT therapy given within 7 days of enrollment is sufficient and does not need to be repeated. This will be increased to 14 days upon the next amendment

 

  1. 2. Drug Preparation and Ordering

How do I place an order for the initial drug supply?

Answer: The initial order should be placed through TACL Ops via an email. Future drug orders should be placed using the Suvoda IRT system. If your site needs Suvoda IRT accounts to be created, please provide a list of names, email addresses, and drug shipment address to TACL Ops.

When can I place my initial drug request?

Answer: After TACL has confirmed that your site is activated.

What should we expect for turnaround time for drug?

Answer: ~12 business days from submission of drug request to TACL Ops/Suvoda System.

How do I use the Suvoda IRT system?

Answer: Please refer to the Suvoda IRT Manual found on the T2020-006 Tag Study page in the Member’s Section of the TACL website.

 

  1. 3. Regulatory

Will a Spanish version of the consent document be provided?

Answer: No.

 

  1. 4. Enrollment and Eligibility

a. Eligibility:

Albumin independence: If a patient were to receive supplementation, what is the washout period before they would be considered albumin independent?

Answer: We leave this up to the enrolling physician as to whether they think the patient has an independently supported albumin or not. If albumin is ≥ 3.2 but < 4.0, the protocol does encourage a dose of albumin prior to initiating Tag.

Heart Rate Percentile: Is there a specific instrument that you would like us to use?

Answer: This can be based on institutional definitions.

  1. Enrollment:

Can you provide an estimated turnaround time for study team eligibility review once the site provides the completed eligibility checklist?

Answer: If the eligibility documents are correctly filled out then it can happen in less than a day following study chair or vice chair review. If clarifications are required, then turnaround time can be impacted.

 

  1. 5. Study Samples
    1. PK/Immunogenicity Samples:

Can samples be drawn from same lumen of line through which drug is infused (if flushed adequately) or do they need to be drawn from a separate site?

Answer: The PK/immunogenicity samples should not be drawn from the lumen through which the study drug is infused. If a central line has multiple lumens, the alternative lumen may used. For single lumen lines, an alternative site will need to be chosen.