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A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients


Phase 2
55 Years
N/A
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients


Patients aged 55 years or over will be assessed for response to steroids from day -7 to day
0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be
treated according to the another French Protocol while patients with Ph-ve ALL will be
included in the "caelyx" protocol and randomly allocated to induction with VAD or with
vadox-li-Peg (caelyx).

A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+
cyclophosphamide(according to the initial randomization arm) will then be given to all
patients.

Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the
initial random allocation, followed by two courses of cytarabine,cyclophosphamide and
thioguanine.

During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin
pharmacokinetics will be assessed in all patients.

Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal
injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and
methotrexate will then be offered to all patients.


Inclusion Criteria:



- 55 years of age and older

- ECOG performance /=3

- VIH negative

- Absence of previous ALL treatment

- Informed consent signed

- SGPT and Bilirubin < 4x upper limit of normal

- Normal creatinine for age

- cardiac state compatible with anthacyclin

Exclusion Criteria:

- ALL with Philadelphia Chromosome

- ALL3

- CML blasts crisis

- Cardiac insufficiency and/ or left ventricular ejection fraction < 50%

- Evolutive infection

- Presence of other evolutifs cancer or ongoing treatment

- mental status incompatible with inform consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy

Outcome Time Frame:

113 days

Safety Issue:

Yes

Principal Investigator

Mathilde HUNAULT BERGER, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

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

Study ID:

GOELAL LALA SA1

NCT ID:

NCT00600977

Start Date:

March 2002

Completion Date:

October 2006

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • ALL
  • Chemotherapy
  • Pharmacokinetics of doxorubicin (pegylated or not)
  • elderly ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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