Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
Public ClinicalTrials.gov record NCT03792256. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, in Combination With Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.
Study identification
- NCT ID
- NCT03792256
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Palbociclib Drug
- Cytarabine Drug
- Methotrexate Drug
- Hydrocortisone Drug
- Doxorubicin Drug
- Prednisolone Drug
- Vincristine Drug
- Pegaspargase Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Months to 31 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2019 (Actual)
- Primary completion
- Jun 30, 2021 (Actual)
- Completion
- Sep 30, 2023 (Actual)
- Last update posted
- Mar 21, 2025
2019 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03792256, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03792256 live on ClinicalTrials.gov.