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NCT01316549: HCT
Study of Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation
trial testing Fludarabine in Hematologic Malignancies in 67 participants. Completed in 30 April 2016.
30 April 2016
Quick facts
| Lead sponsor | University of California, San Francisco |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 67 |
| Start date | 1 January 2011 |
| Primary completion | 30 April 2016 |
| Estimated completion | 30 April 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fludarabine (FLUDARABINE) — full drug profile →
Conditions studied
- Hematologic Malignancies — all drugs for Hematologic Malignancies →
- Nonmalignant Diseases — all drugs for Nonmalignant Diseases →
- Immunodeficiencies — all drugs for Immunodeficiencies →
- Hemoglobinopathies — all drugs for Hemoglobinopathies →
Sponsor
University of California, San Francisco
Who can join
Under 17, any sex, with Hematologic Malignancies or Nonmalignant Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetics and Model-Based Dosing to Optimize Fludarabine Therapy in Pediatric Hematopoietic Cell Transplant Recipients.
Ivaturi V, Dvorak CC, Chan D, Liu T, et al · · 2017 · cited 49× · PMID 28684371 · DOI 10.1016/j.bbmt.2017.06.021
Verify or expand the search:
- PubMed search for NCT01316549
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other University of California, San Francisco trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01316549 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
- Last refreshed: 4 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01316549.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing