Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04996160 · ClinicalTrials.gov registry record · Phase 1
Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)
A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, Pediatric, sponsored by Tanja Andrea Gruber.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04996160: Recruiting Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, Pediatric, sponsored by Tanja Andrea Gruber.
NCT04996160 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, Pediatric that is actively recruiting participants, run by Tanja Andrea Gruber. The registered enrollment target is 22 participants, below the 44-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04996160, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, Pediatric, is actively recruiting participants, sponsored by Tanja Andrea Gruber.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
With this research study has following goals * To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated. * To learn more about side effects of palbociclib in combination with chemotherapy; * To learn more about the biological effects of palbociclib on the cells in your body
Primary Outcome
The primary outcome for this study, for the purposes of Clinical Trials.gov registration and results reporting, is dose-limiting toxicities (DLTs) experience by subjects without the Ph+ / Ph-like mutation (Cohort 1), and those with the Ph+ / Ph-like mutation (Cohort 2). The outcome will be reported for Cohorts 1 and 2 as the number of DLTs that occur within 30 days of last treatment with palbociclib. Results for Cohort 2 may be stratified by dose level administered.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Palbociclib
- DRUG Bortezomib
Study Locations (1)
California
- Lucile Packard Children's Hospital Stanford - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What NCT04996160 shows while recruiting
NCT04996160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 44-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (50% lower).
The record links to 3 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Doxorubicin is the first listed.
NCT04996160 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04996160 about?
NCT04996160 is a clinical study titled "Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)". With this research study has following goals * To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated. * To learn more about side effects of palbociclib in combination with chemotherapy; * To learn more about the biological effects of palboc...
What is the current status of trial NCT04996160?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-07-09. Estimated completion is 2025-12.
What conditions does trial NCT04996160 study?
This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04996160?
The interventions under investigation include: Doxorubicin (DRUG), Dexamethasone (DRUG), Palbociclib (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04996160?
This trial is sponsored by Tanja Andrea Gruber, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04996160 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04996160's enrollment target sits among peer trials
22 19th of 21 higher than 2 of 21 other Refractory Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
RECRUITING · Phase 1
-
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
RECRUITING · Phase 1
-
Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia
RECRUITING · Phase 1
-
Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia
RECRUITING · Phase 1
-
ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI