Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
Recruiting
Phase 3
Interventional Study
Acute Myeloid Leukemia
Myelodysplastic Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 55
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 222 (estimated)
- Sponsor
- Shanghai Jiao Tong University School of Medicine · Other
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About This Trial
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-cent…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
* myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation
* patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identi…
Contacts