German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Sponsor: Goethe University
Study ID: NCT00198978
Phase: PHASE4
Status: Completed

Conditions

Adult Acute Lymphocytic Leukemia

Eligibility Criteria

Sex: ALL
Age: 55 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide — DRUG
Dexamethasone / Prednisolone — DRUG
Cytarabine — DRUG
Idarubicin — DRUG
Granulocyte-Colony-Stimulating Factor — DRUG
Mercaptopurine — DRUG
Methotrexate — DRUG
Rituximab — DRUG
HDARAC — DRUG
Vincristine — DRUG
Depocyte — DRUG
Asparaginase — DRUG

Study Details

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

Key Dates

Start date: Jan 31, 2003
Status verified: Mar 2023
Primary completion: Jun 30, 2011
Completion: Jun 30, 2014

Study Design

Enrollment: 377 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Interventional arm

Primary Outcome Measure

Remission rate (cytologic, molecular) [ Time Frame: After induction; approximately 6 wks (exact time frame not specified) ]