Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501614
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2020-08-04
Brief Title:
A Study of Ponatinib With Chemotherapy in Children Teenagers and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Pivotal Phase 12 Single-Arm Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive Ph Acute Lymphoblastic Leukemia ALL Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy or Who Have the T315I Mutation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children teenagers and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment
The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects and to evaluate if participants leukemia achieves remission
Participants will take ponatinib tablets with chemotherapy For participants who cannot swallow tablets or who are receiving less than a 10 mg dose a capsule with small ponatinib minitablets inside will be provided Participants will take ponatinib for 10 weeks in combination with chemotherapy reinduction and consolidation blocks and will be followed up for at least 3 years
The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects and to evaluate if participants leukemia achieves remission
Participants will take ponatinib tablets with chemotherapy For participants who cannot swallow tablets or who are receiving less than a 10 mg dose a capsule with small ponatinib minitablets inside will be provided Participants will take ponatinib for 10 weeks in combination with chemotherapy reinduction and consolidation blocks and will be followed up for at least 3 years
Detailed Description:
The drug being tested in this study is called ponatinib Ponatinib is being tested to treat pediatric population who have Philadelphia chromosome-positive Ph acute lymphoblastic leukemia ALL Ph mixed phenotype acute leukemia Ph MPAL or Philadelphia chromosome-like ALL who have relapsed or are resistant or intolerant to a prior tyrosine kinase inhibitor TKI-containing therapy or who have the T315I mutation
The study will enroll approximately 68 participants Participants will be assigned to a treatment group either in phase 1 or phase 2 Participants unable to swallow the ponatinib tablets or who are receiving less than a 10 mg dose will receive the age-appropriate formulation capsule with ponatinib minitablets inside
Ponatinib Chemotherapy
All participants will be asked to take ponatinib once daily In phase 1 ponatinib will be administered in combination with a chemotherapy backbone to determine the recommended phase 2 dose RP2D of ponatinib In both phase 1 and phase 2 treatment consists of two 35-day blocks of therapy reinduction block and consolidation block Each block will include 29 days of treatment of daily ponatinib and a chemotherapy backbone regimen followed by a rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only
This is a multi-center trial and will be conducted worldwide The overall time to participate in this study is 65 years Participants will make multiple visits to the clinic and may be contacted by telephone in at least 36 months of follow-up after treatment
The study will enroll approximately 68 participants Participants will be assigned to a treatment group either in phase 1 or phase 2 Participants unable to swallow the ponatinib tablets or who are receiving less than a 10 mg dose will receive the age-appropriate formulation capsule with ponatinib minitablets inside
Ponatinib Chemotherapy
All participants will be asked to take ponatinib once daily In phase 1 ponatinib will be administered in combination with a chemotherapy backbone to determine the recommended phase 2 dose RP2D of ponatinib In both phase 1 and phase 2 treatment consists of two 35-day blocks of therapy reinduction block and consolidation block Each block will include 29 days of treatment of daily ponatinib and a chemotherapy backbone regimen followed by a rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only
This is a multi-center trial and will be conducted worldwide The overall time to participate in this study is 65 years Participants will make multiple visits to the clinic and may be contacted by telephone in at least 36 months of follow-up after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1225-0394 | OTHER | WHO | None |
| 2019-002549-39 | EUDRACT_NUMBER | None | None |