Early intensification by (un)related allogeneic or autologous stem cell transplantation in adult acute lymphoblastic leukemia. A phase II study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20150

Enrollment

200

Registered

2005-09-06

Start date

1999-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (ALL).

Interventions

All patients will receive early intensification: - cycle 1: prednisone, vincristine, daunorubicin, aspariganse, MTX i.t. - cycle 2: Cytarabine, Mitoxantrone, MTX i.t. - cycle 3: Methotrexate, aspar

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 16 and 59 (inclusive) years; 2. Previously untreated with chemotherapy; 3. ALL according to the FAB criteria and immunological marker analysis (B-precursor ALL, T-ALL and AUL); 4. WHO performance status grade 0, 1, 2 or 3; 5. Patient informed consent.

Exclusion criteria

Exclusion criteria: 1. B-ALL (= mature B-ALL); 2. Severe cardiac, pulmonary, hepatic, renal, neurologic, psychiatric or metabolic disease; 3. Second malignant disease, except cervix carcinoma stage I and non-melanoma skin cancer; 4. Persisting renal insufficiency, creatinine more than 200 mmol/l; 5. Active uncontrolled infections; 6. HIV positivity on serological tests.

Design outcomes

Primary

Measure	Time frame
Response after each course of chemotherapy and date of CR.	—

Secondary

Measure	Time frame
1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first); 2. Event-free survival (i.e., time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day; 3. Overall survival will be measured from time of registration until death or last contact; 4. Toxicities and treatment related mortality.	—

Measure

Time frame

1. Disease-free survival (i.e. time from achievement of first CR to the date of relapse or death from any cause, whichever occurs first); 2. Event-free survival (i.e., time from start of therapy to the date of no complete response, death or relapse whichever occurs first): this takes into consideration induction failures and toxic deaths. The time to failure of patients with induction failure is set at one day; 3. Overall survival will be measured from time of registration until death or last contact; 4. Toxicities and treatment related mortality.

—

Contacts

Public ContactA.W. Dekker

University Medical Center Utrecht (UMCU), Department of Hematology, (G03.647), P.O. Box 85500

a.w.dekker@azu.nl+31 (0)30 2507655

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)