Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01835288|
Recruitment Status : Withdrawn
First Posted : April 18, 2013
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Recurrent Adult Acute Myeloid Leukemia||Drug: arsenic trioxide Other: laboratory biomarker analysis||Phase 2|
I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.
I. Determine the duration of remission in these patients. II. Determine the in vivo biological effect of arsenic trioxide in AML with mutated NPM1.
Patients receive arsenic trioxide intravenously (IV) over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Arsenic Trioxide in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Mutated Nucleophosmin 1 (NPM1) Gene|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2015|
Experimental: Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: arsenic trioxide
Other: laboratory biomarker analysis
- Rate of complete remission following arsenic trioxide induction [ Time Frame: After 4 weeks of therapy ]
- Median duration of remission [ Time Frame: Time from documented complete remission until time of disease relapse, assessed up to 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835288
|Principal Investigator:||Bruno de Medeiros||Stanford University|