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Oral Topotecan in Children With Relapsed Acute Leukemia
NCT00003735Phase 2
Key facts
- Status
- Completed
- Start
- Dec 1998
- Primary completion
- Nov 2002
- Countries
- 3
- Sponsor
- Children's Oncology Group
- Modality
- Small Molecules
- Drugs
- topotecan
- Conditions
- acute lymphoblastic leukemia (ALL)acute myeloid leukemia (AML)chronic myelogenous leukemia (CML)
01
Overview
Phase 2, open-label trial of topotecan in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and chronic myelogenous leukemia (CML) (2 arms), sponsored by Children's Oncology Group. Primary endpoints: Disease Progression at 21 days and Response Rate. Started Dec 1998; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Stratum 1 (ALL)
Patients with relapsed ALL receive oral topotecan.
Stratum 2 (AML)
Patients with relapsed AML receive oral topotecan.
03
Who it enrols
Children and young adults (<=21 years) with relapsed ALL, AML, or blast phase CML, refractory to conventional therapy. Must have adequate organ function and recovered from prior therapy.
04
Endpoints
Primary
Disease Progression
Response Rate
Secondary
Toxic Effects
Pharmacokinetics
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