Comparator supply for NCT01949129
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Sponsor: St. Anna Kinderkrebsforschung (OTHER). Phase: PHASE2, PHASE3. Status: Recruiting. Countries: Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye). Last update posted 2026-09-04.
Registry record: https://clinicaltrials.gov/study/NCT01949129.
Canadian-labelled busulfan
3 marketed Canadian product(s) from 3 manufacturer(s) contain busulfan. Available strengths: 2 MG, 6 MG, 60 MG / 10 ML. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled cyclophosphamide
10 marketed Canadian product(s) from 3 manufacturer(s) contain cyclophosphamide. Available strengths: 1000 MG, 200 MG, 2000 MG, 25 MG, 50 MG, 500 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled etoposide
3 marketed Canadian product(s) from 3 manufacturer(s) contain etoposide. Available strengths: 20 MG, 50 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled fludarabine
3 marketed Canadian product(s) from 3 manufacturer(s) contain fludarabine phosphate. Available strengths: 10 MG, 25 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled thiotepa
7 marketed Canadian product(s) from 3 manufacturer(s) contain thiotepa. Available strengths: 100 MG, 15 MG, 400 MG. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
Canadian-labelled treosulfan
1 marketed Canadian product(s) from 1 manufacturer(s) contain treosulfan. Available strengths: 5 G. Because the comparator is registered in Canada, supply can be arranged without a Special Access request and with the Canadian label, package insert and lot documentation the protocol expects.
What we supply
- Canadian-labelled comparator sourced through licensed Canadian supply
- Certificate of Analysis for every batch
- Batch number and expiry documentation, with retained records
- Blinding-ready packaging and over-encapsulation on request
- 2–8 °C validated cold chain with temperature logging where required
- Health Canada Drug Establishment Licence #3-002896
Frequently asked questions
Can Nexara supply Canadian-labelled busulfan as a trial comparator?
Yes. We source Canadian-marketed busulfan under Health Canada Drug Establishment Licence #3-002896 and ship it with Certificate of Analysis, batch number and expiry documentation for use as a comparator or rescue supply in NCT01949129.
What documentation comes with each shipment?
Certificate of Analysis, manufacturer batch and expiry records, chain-of-custody documentation from the Canadian supply chain, and temperature records where cold chain applies. Blinding-ready packaging is available on request.
How long does comparator supply take?
Quotes are returned within one business day. Lead time depends on the presentation and the destination country's import route — typically 10 to 21 days once the importer's licence and any notification are in place.
Request comparator quote
Request comparator quote or call +1-431-588-9055.