Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML

Cooperative Study Group A for Hematology

Status and phase: Unknown; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Fludarabine , cytarabine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00529880

C-008

Details and patient eligibility

About

• To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
• The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Full description

• A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.

• G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.

• For the patients who achieve a complete remission, consolidation therapy will be given as follows:

  • Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
  • In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
  • In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).

Enrollment: 19 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Failure to achieve CR after initial induction chemotherapy
• Any relapse, regardless of the frequency and time of relapse from first CR
• Relapse after hematopoietic cell transplantation, allogeneic or autologous.
• Multiple relapses, extramedullary relapse(s)

Exclusion criteria

• Inadequate hepatic,renal,cardiac function
• Psychiatric disorder or mental deficiency
• CNS involvement of leukemic blasts

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)