Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03746912|
Expanded Access Status : No longer available
First Posted : November 20, 2018
Last Update Posted : April 15, 2020
An expanded access program (EAP):
- Allows doctors to give medicine to patients,
- Before it is approved by health authorities.
This EAP is for:
- Patients with FLT3-ITD mutated AML,
- AML that has come back, or
- Is resistant to other therapies.
A participant will receive quizartinib if:
- The doctor submits a request,
- The participant is eligible, and
- The country allows the EAP.
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia With Gene Mutations||Drug: Quizartinib Dihydrochloride|
This is an expanded access program (EAP) providing access to quizartinib for participants with Relapsed/Refractory FLT3-ITD mutated AML, prior to approval by local regulatory agencies. Availability of the EAP is dependent upon physician request, country eligibility and local/country regulations. EAP countries included Austria, Belgium, Brazil, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and United States. Physicians may request access to the EAP for participants who they feel may benefit from quizartinib and meet the eligibility criteria.
Participants may continue quizartinib until there is a lack of clinical benefit or the occurrence of unacceptable toxicity. Treatment should be interrupted for allogeneic hematopoietic stem cell transplantation (HSCT), but may be resumed after the transplant.
Participant enrollment may continue until 18 months after regulatory approval, depending on country regulation; or until such time the marketed medication is available, whichever occurs first.
Participants will be asked to follow the care as outlined by their treating physician. Participants will be followed for 30 days after their final treatment or until the patient is transitioned to commercially available product. Physicians will be required to report safety data to Daiichi-Sankyo Inc.
Quizartinib is currently under development for the treatment of patients 18 years of age or older with relapsed (including after HSCT) or refractory FLT3-ITD mutated AML, and has been granted Fast Track Status in the US and an Orphan Drug Indication in the United States, Europe and Asia.
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||An Open-Label, Multi-Center, Expanded Treatment Protocol of Quizartinib in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3-ITD Mutations|
- Drug: Quizartinib Dihydrochloride
Tablets for once daily oral administration at doctor-recommended dose in continuous 28-day cyclesOther Name: Quizartinib