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NCT03955601: FluCAB-Prime
A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia:
Phase 2 trial testing Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide'' in Aplastic Anemia Idiopathic in 30 participants. Status unknown.
30 December 2020
Quick facts
| Lead sponsor | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 12 July 2018 |
| Primary completion | 30 December 2020 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide'' — full drug profile →
Conditions studied
- Aplastic Anemia Idiopathic — all drugs for Aplastic Anemia Idiopathic →
Sponsor
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
Who can join
Adults 2 to 60, any sex, with Aplastic Anemia Idiopathic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Severe and very severe aplastic anemia are life threatening disorders for which allogeneic stem cell transplant is only curative treatment. However, matched sibling donor (MSD) is available in only 25-35% cases. Pakistan has a population of around 203 million but there is no donor registry available so there is no option available for matched unrelated donor (MUD) transplants . Haploidentical transplant represents only curative option for patients lacking MSD. Protocols involving post transplant cyclophosphamide require Total body irradiation (TBI) and utilize peripheral blood stem cell(PBSC) as graft source. TBI is not available in most of transplant centres across Pakistan due to lack of availability , cost and lack of expertise. The investigators have conceived a novel TBI free conditioning regimen to be used for haplo-identical Hemtopoeitic stem cell transplant in acquired aplastic anemia patients
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03955601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT03955601 (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 National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
- Last refreshed: 11 August 2020
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/NCT03955601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing