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NCT01767714
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Phase 3 trial testing Granulocyte-colony stimulating factor (G-CSF) in Non-Hodgkin's Lymphoma in 100 participants. Completed in 1 November 2014.
1 November 2014
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 April 2013 |
| Primary completion | 1 November 2014 |
| Estimated completion | 1 November 2014 |
| Sites | 16 locations across China |
Drugs / interventions tested
- Granulocyte-colony stimulating factor (G-CSF) — full drug profile →
- Plerixafor (plerixafor) — full drug profile →
- Placebo
Conditions studied
- Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →
Sponsor
Sanofi — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-Hodgkin's Lymphoma. 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.
-
Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
Time frame: Days 5- Day8
Sponsor's own description
The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day \[GRAN® only\]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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New genetic and epigenetic insights into the chemokine system: the latest discoveries aiding progression toward precision medicine.
Xu H, Lin S, Zhou Z, Li D, et al · · 2023 · cited 37× · PMID 37198402 · DOI 10.1038/s41423-023-01032-x -
Additional plerixafor to granulocyte colony-stimulating factors for haematopoietic stem cell mobilisation for autologous transplantation in people with malignant lymphoma or multiple myeloma.
Hartmann T, Hübel K, Monsef I, Engert A, et al · · 2015 · cited 15× · PMID 26484982 · DOI 10.1002/14651858.cd010615.pub2 -
Life-long passion for antiviral research and drug development: 80th birthday of Prof. Dr. Erik De Clercq.
Li G, Xu M, Yue T, Gu W, et al · · 2021 · cited 12× · PMID 33617841 · DOI 10.1016/j.bcp.2021.114485 -
G-CSF + plerixafor versus G-CSF alone mobilized hematopoietic stem cells in patients with multiple myeloma and lymphoma: a systematic review and meta-analysis.
Li Y, Qiu X, Lei Y, Zhou R. · · 2024 · cited 3× · PMID 38470973 · DOI 10.1080/07853890.2024.2329140
Verify or expand the search:
- PubMed search for NCT01767714
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Granulocyte-colony stimulating factor (G-CSF)
Trials testing the same drug.
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- NCT00632827 — Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) · Phase 2 · terminated
Other recruiting trials for Non-Hodgkin's Lymphoma
Currently open trials in the same condition.
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- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
- NCT05884333 — Cord Blood Transplant in Adults With Blood Cancers · Phase 2 · recruiting
- NCT04532203 — A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Maligna · EARLY_PHASE1 · recruiting
Other Sanofi trials
Trials by the same sponsor.
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- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · 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 NCT01767714 (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 Sanofi
- Last refreshed: 8 December 2014
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/NCT01767714.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing