NCT00630565

Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

Autologous Peripheral Blood Stem Cell Transplant for Acute Non-Lymphocytic Leukemia (ANLL)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy and colony-stimulating factors, such as G-CSF, may increase the number of stem cells in the blood. The stem cells are collected from the patient's blood and stored. Chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.

Detailed description

OBJECTIVES: * To assess whether sufficient peripheral blood stem cells (PBSC) can be collected from patients with acute myeloid leukemia (AML) using cyclophosphamide, etoposide, and granulocyte-colony stimulating factor (G-CSF) mobilization. * To assess the rate of myeloid, platelet, and erythroid recovery following autologous PBSC transplant. * To assess the disease-free survival rate of patients with AML receiving PBSC auto grafts. OUTLINE: * Chemotherapy and filgrastim (G-CSF) priming for PBSC collection: Patients receive cyclophosphamide IV on day 0; etoposide IV over 3 hours on days 0 and 1; and oral dexamethasone twice daily on days 0 and 1. Patients also receive G-CSF subcutaneously (SC) beginning on day 3 and continuing until apheresis is complete. After blood counts recover, apheresis is performed in 4-6 daily planned collections until the minimum CD34+ cell dose of \> 2.5 x 10\^6 cells/kg is achieved. If the minimum CD34+ cell dose is not achieved after 6 apheresis collections, patients undergo bone marrow examination including a bone marrow biopsy and aspiration, at the termination of the PBSC collection to confirm remission. If remission is confirmed, and if peripheral counts and marrow cellularity are sufficient, the patient remains off G-CSF for 7 days and receives sargramostim (GM-CSF) for 5 days to increase the marrow cellularity, after which a bone marrow harvest is performed. * Bone marrow harvest without prior PBSC collection: Children will undergo primed bone marrow harvest comprising GM-CSF IV or SC for 5 days prior to harvest to increase cellularity and then marrow is harvested. Marrow and blood specimens are also obtained with the initial bone marrow evaluation and at the time of harvest if a cytogenetic abnormality was previously described. Other patients who are unable to undergo PBSC collection may proceed with a bone harvest at the discretion of the protocol chairperson. * Cytoreductive regimen: * Patients over 2 years old: Patients undergo total body irradiation (TBI) twice daily on days -7 to -4 (total of 8 fractions), cyclophosphamide IV over 2 hours on days -3 and -2, followed by a 1-day rest period on day -1. * Patients under 2 years old and patients who cannot undergo TBI: Patients receive busulfan IV or orally every 6 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, followed by a 1-day rest period on day -1. * Stem cell transplantation: All patients undergo autologous PBSC and/or bone marrow infusion on day 0. Patients also receive G-CSF IV or SC beginning on day 1 and continuing until blood counts recover. After completion of study treatment, patients are followed periodically for 5 years.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim	Given subcutaneously (SC) 10 μg/kg/day from day +3 until apheresis is completed
DRUG	busulfan	4 mg/kg po in 4 divided doses (.8 mg/kg/dose orally every 6 hours) on days -7 through -4.
DRUG	cyclophosphamide	4 gm/m\^2 x 1 (day 0) and 60 mg/kg intravenous (IV) over 2 hours on days -3 and -2.
DRUG	dexamethasone	20 mg/m\^2 x 4 doses every 12 hours given intravenously (IV) push before cytoxan on day 0 and then every 12 hours
DRUG	etoposide	300 mg/m\^2/day x 2 days (day 0-1) over 3 hours intravenously (IV)
PROCEDURE	bone marrow transplantation	Day 0 infusion of bone marrow cells
PROCEDURE	hematopoietic stem cell transplantation	Stem cell infusion (\>48 hours after the last dose of cyclophosphamide)
PROCEDURE	peripheral blood stem cell transplantation	Day 0 infusion of peripheral blood stem cells
RADIATION	total-body irradiation	165 cGy/dose given twice a day on days -7 through -4.

Timeline

• Start date: 2006-07-26
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2008-03-07
• Last updated: 2024-01-29
• Results posted: 2024-01-29

Locations

1 site across 1 country: United States