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NCT03799224
Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia
Phase 2, PHASE3 trial testing Decitabine in Stem Cell Transplant Complications in 55 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 December 2018 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Decitabine (decitabine) — full drug profile →
- mBU/CY and ATG — full drug profile →
- mBU/CY — full drug profile →
Conditions studied
- Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
- Relapse Leukemia — all drugs for Relapse Leukemia →
- Refractory Leukemia — all drugs for Refractory Leukemia →
Sponsor
Peking University People's Hospital
Who can join
Adults 18 to 55, any sex, with Stem Cell Transplant Complications or Relapse Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03799224
- Europe PMC full search
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- ESMO Meeting Library
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Currently open trials in the same condition.
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Other Peking University People's Hospital 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 NCT03799224 (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 Peking University People's Hospital
- Last refreshed: 29 May 2019
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