Acute Promyelocytic Leukemia Clinical Trial
Official title:
Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study
In this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia, patients will be randomized (1:1) into two groups which receive retinoic acid and arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.
The study is carried out based on Sanz risk stratification of newly-diagnosed APL patients
into low-, intermediate- and high-risk groups, and all of them will receive ATRA and ATO as
induction therapy (ATRA 25 mg/m2 per day orally + ATO 0.16mg/kg intravenously daily).
Anthracycline is added to both high-risk groups or intermediate-risk group with
hyperleukocytosis developed during induction therapy but not in low-risk groups.
After achieving CR, patients enter into consolidation therapy. Low-risk patients receive
either 2 courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus
anthracycline chemotherapy (Control group). Intermediate-risk patients receive either 3
courses of ATRA plus ATO (Experimental group) or 2 courses of ATRA plus anthracycline
chemotherapy (Control group). Patients of high-risk disease receive 2 courses of ATRA plus
ATO and anthracycline and 1 course of ATRA plus ATO treatment (Experimental group) or 2
courses of ATRA plus anthracycline and cytarabine and 1 course of ATRA plus mid-dose
cytarabine (Control group).
After consolidation therapy, patients with molecular complete remission (mCR) enter into
maintenance therapy. Low- and intermediate-risk patients receive 3 cycles of ATRA and ATO
sequential treatment, while those of high-risk receive 5 cycles of ATRA, ATO and methotrexate
(MTX) treatment.
For low- and intermediate-risk patients who fail to achieve mCR after consolidation therapy,
3 courses of consolidation therapy of high-risk group will be given with cross-over (i.e.
patients in Experimental group received the therapy of Control group, and patients in Control
group received the therapy of Experimental group). If patients still fail to achieve mCR,
together with high-risk group who fail to achieve mCR after consolidation therapy will be
withdrawn from the study and proceed to salvage treatment.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00520208 -
Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL
|
Phase 2 | |
Suspended |
NCT04996030 -
A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT02899169 -
Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)
|
Phase 3 | |
Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
Recruiting |
NCT04793919 -
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT02938858 -
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
|
N/A | |
Recruiting |
NCT02991066 -
Role of Microparticles in the Coagulopathy of Acute Promyelocytic Leukemia
|
||
Terminated |
NCT00985530 -
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
|
Phase 1 | |
Withdrawn |
NCT00670150 -
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT01064570 -
AIDA 2000 Guidelines
|
Phase 2 | |
Completed |
NCT01472107 -
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
|
||
Active, not recruiting |
NCT03096496 -
Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy
|
||
Completed |
NCT00465933 -
Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA)
|
Phase 4 | |
Active, not recruiting |
NCT02688140 -
Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia
|
Phase 3 | |
Terminated |
NCT00907582 -
ASCT for Relapsed APL After Molecular Remission
|
Phase 2 | |
Recruiting |
NCT00517712 -
Single Agent Arsenic Trioxide in the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia
|
Phase 2/Phase 3 | |
Completed |
NCT01902329 -
A Safety Study of SGN-CD33A in AML Patients
|
Phase 1 | |
Completed |
NCT01404949 -
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
|
Phase 2 | |
Completed |
NCT00504764 -
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
|
Phase 4 | |
Completed |
NCT00408278 -
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
|
Phase 4 |