Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

Summary: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.
  PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.
  Secondary
  -  Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
  -  Determine the 1-year survival of patients treated with this drug.
  OUTLINE: This is an open-label, pilot, multicenter study.
  Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.
  Patients are followed for survival.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p^190 and/or p^210 bcr/abl gene rearrangement
  -  Accelerated or blastic phase CML
  -  CML in second or greater chronic phase
  -  No imatinib mesylate-resistant leukemia
  -  Planned allogeneic hematopoietic stem cell transplantation
  -  Availability of an appropriately matched related or unrelated donor
  -  Autologous or nonmyeloablative transplantation is not allowed
  -  None of the following within 4 days after the date of neutrophil engraftment*:
  -  More than 5% marrow blasts
  -  Circulating peripheral blood leukemic blasts
  -  Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay
  -  Presence of bcr/abl in > 5% of marrow interphase nuclei by fluorescent in situ hybridization
  -  More than 1 of 20 Philadelphia chromosome-positive marrow metaphases
  -  CNS involvement by leukemia NOTE: *The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3
  PATIENT CHARACTERISTICS:
  Performance status
  -  Not specified
  Life expectancy
  -  At least 2 months
  Hematopoietic
  -  See Disease Characteristics
  -  Absolute neutrophil count ≥ 1,200/mm^3 (use of filgrastim [G-CSF] allowed)
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No known imatinib mesylate hypersensitivity
  -  No other disease that severely limits life expectancy
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  See Disease Characteristics

Relevance to patient case: definitely relevant