Know Cancer

or
forgot password

Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia


Phase 2
18 Years
60 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia


OBJECTIVES: I. Determine safety and toxicity of induction and transplant regimens in
patients with chronic myelogenous leukemia or high-risk acute leukemia. II. Determine
efficacy of collecting peripheral blood stem cells (PBSC) during early hematopoietic
recovery from intensive chemotherapy as a means for in vivo enrichment for cytogenetically
normal progenitor cells in this patient population. III. Correlate cytogenetic and molecular
responses in the peripheral blood and bone marrow with clinical response, time to
progression, and survival in these patients at several timepoints before and after
myelosuppressive and myeloablative therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic
myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia).
Patients receive cytarabine IV over 4 hours, etoposide IV over 1.5-2 hours, and idarubicin
IV over 5-10 minutes on days 1, 3, and 5. Filgrastim (G-CSF) is administered subcutaneously
(SC) daily beginning on day 2 and continuing until blood counts recover. Chronic myelogenous
leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20%
cellularity and a peripheral blood sample contains greater than 50% cytogenetically normal
cells, patients receive a second induction course followed by apheresis. Patients with less
than 50% cytogenetically normal cells are also considered for a second induction course.
Patients with no response or progressive disease are removed from the study. Acute leukemia:
On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and
the peripheral blood sample shows 100% cytogenetically normal cells, patients receive a
second induction course followed by apheresis. Patients with high risk disease in first
remission at time of study entry undergo apheresis during recovery from first course of
induction therapy and second course may be omitted. Patients receive second induction course
followed by G-CSF as after first induction course. Once blood counts recover, patients
undergo harvest of peripheral blood stem cells (PBSC). Patients also undergo bone marrow
stem cell collection in case of failure of PBSC transplantation (PBSCT). Patients receive
the following conditioning regimen: total body irradiation twice a day on days -8 to -5;
etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 2 hours on day -2. PBSCT
is conducted on day 0. G-CSF SC is administered beginning on day 1 and continues until blood
counts recover. Patients receive maintenance therapy with interferon alfa SC 3 times a week
for 12 months. Patients are followed weekly for 3 months and then monthly until death.

PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: One of the following hematologic conditions: Chronic phase or
advanced chronic myelogenous leukemia Acute lymphoblastic leukemia: -relapsed -in second
remission or later -in first remission with unfavorable prognostic features Acute
myelogenous leukemia: -in second remission or later -in first remission with high-risk
features Detectable clonal cytogenetic or molecular abnormality at time of diagnosis Not
eligible for allogenic bone marrow transplant

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper
limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine clearance greater
than 60 mL/min Cardiovascular: Ejection fraction greater than 45% Pulmonary: DLCO greater
than 60% FEV1 greater than 60% Other: No serious underlying medical condition that would
preclude study Not pregnant or nursing No cerebellar dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy:
Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior
radiotherapy allowed Surgery: Prior surgery allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jane N. Winter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

LUMC-5892

NCT ID:

NCT00004905

Start Date:

October 1999

Completion Date:

September 2004

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Loyola University Medical CenterMaywood, Illinois  60153