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A Randomized Trial Assessing the Roles of AraC in Newly Diagnosed Acute Promyelocytic Leukemia (APL)

Phase 3
Not Enrolling
Leukemia, Promyelocytic, Acute

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Trial Information

A Randomized Trial Assessing the Roles of AraC in Newly Diagnosed Acute Promyelocytic Leukemia (APL)

All patients will receive induction treatment with ATRA and a first chemotherapy course,
followed by two consolidation chemotherapy courses and maintenance with continuous low dose
chemotherapy and intermittent ATRA. Initial stratification will be based on age and WBC

Patients aged 60 years with initial WBC 10 00 will all receive the reference AraC+ group
(Group A ) (no randomization).

Patients with initial WBC > 10000/mm3 will initially all be treated according to the AraC+

Patients > 60 years and with initial WBC ≤ 10000/mm3) will be only registered, without
randomization (Group D) and will receive the reference AraC+ group ,but without AraC
during the first chemotherapy course ,and with reduced doses of AraC during the second and
third course, followed by G-CSF. .

Inclusion Criteria:

- diagnosis of APL based on morphological grounds, and which will have to be confirmed
by presence of t(15;17) and/or PML-RARα rearrangement (if RT-PCR for APL cannot be
performed at your center, send fresh cells to Prof.C.Chomienne, Centre Hayem, Hopital
St.Louis, 1 av. Claude Vellefaux, 75475 PARIS or keep frozen RNA [not frozen cells,
as the RNA yield for PML-RAR is often poor in those cells]).

- untreated patient

- no contraindication to intensive chemotherapy (especially cardiac contraindication to

- in female patients : absence of pregnancy and adequate contraceptive method (due to
teratogenetic effects of ATRA in early pregnancy)

- written informed consent.

Exclusion Criteria:

- patients already treated

- patients with contraindication to intensive chemotherapy, especially cardiac
contraindication to daunorubicin

- in female patients : pregnancy or absence of adequate contraceptive methods

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

for patients with initial WBC counts > 10000/mm3 - the main end point for this second randomization is relapse at 2 years

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Pierre Fenaux, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2000

Completion Date:

June 2004

Related Keywords:

  • Leukemia, Promyelocytic, Acute
  • APL
  • Leukemia
  • Leukemia, Promyelocytic, Acute