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NCT00410696
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial
Phase 2 trial testing Filgrastim in Hematological Neoplasms in 80 participants. Completed in 1 November 2008.
1 November 2008
Quick facts
| Lead sponsor | Armando Santoro, MD |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 September 2006 |
| Primary completion | 1 November 2008 |
| Estimated completion | 1 November 2008 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Filgrastim — full drug profile →
- Pegfilgrastim (PEGFILGRASTIM) — full drug profile →
Conditions studied
- Hematological Neoplasms — all drugs for Hematological Neoplasms →
- Tumors — all drugs for Tumors →
Sponsor
Armando Santoro, MD — full company profile →
Who can join
18 and older, any sex, with Hematological Neoplasms or Tumors. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Duration of aplasia period
Time frame: At time of discharge from Unit
Sponsor's own description
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00410696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Filgrastim
Trials testing the same drug.
- NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
- NCT06738368 — Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombin · Phase 2 · recruiting
- NCT07278856 — Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphoma · Phase 1 · not yet recruiting
- NCT07059611 — Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
- NCT07224100 — Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosom · Phase 2 · recruiting
Other recruiting trials for Hematological Neoplasms
Currently open trials in the same condition.
- NCT06904066 — Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients W · Phase 1 · recruiting
- NCT07085065 — Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies · NA · recruiting
- NCT03844360 — Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease · Phase 4 · recruiting
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 NCT00410696 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Armando Santoro, MD
- Last refreshed: 28 June 2013
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/NCT00410696.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing