Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

National Research Center for Hematology, Russia

Status: Unknown

Conditions: Ph-negative Adult Acute Lymphoblastic Leukemia

Treatments: Procedure: autologous HSCT

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01193933

ALL-2009

Details and patient eligibility

About

1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more
2. feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance.
3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU)
4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL

Full description

1. The blast count in b/m after 7 days of prednisolone >25% was shown in 64% of patients. The substitution of prednisolone by dexamethasone did not influence survival.
2. "no interruptions" induction was performed in 48% of patients.
3. In 19% of patients the L-asparaginase therapy was stopped due to toxicity.
4. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.

Enrollment: 321 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ph-negative precursors ALL
• age 15-55 years
• nontreated
• Eastern Cooperative Oncology Group criterion status 0-3

Exclusion criteria

• B-mature ALL
• Ph-positivity
• pretreatment
• Eastern Cooperative Oncology Group criterion status 4

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)