Clinical trial NCT00185523: Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Official title: Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leukemia, Lymphocytic, Acute
Leukemia
Leukemia Acute Promyelocytic Leukemia (APL)
Leukemia Acute Lymphoid Leukemia (ALL)
Leukemia Chronic Myelogenous Leukemia (CML)
Leukemia Acute Myeloid Leukemia (AML)
Leukemia Chronic Lymphocytic Leukemia (CLL)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.

Detailed description: Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase

Eligibility criteria: Inclusion Criteria:1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:

1. acute myelogenous leukemia, 1st or 2nd remission
2. acute lymphoblastic leukemia, 1st or 2nd remission
3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age \> 1 month and \< 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:

a. total bilirubin \<2.5 and SGOT/SGPT \<2x normal b. adequate renal function as defined by creatinine \< 1.5 or a 24 hr creatinine clearance \>50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine \> 1.5) c. DLCO \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. Patient must be competent to give consent.

Inclusion criteria (Donor):

1. HLA identical family member
2. Donor or guardian must be competent to give consent
3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter

Exclusion Criteria:3.2 Exclusion Criteria (Patient):

1. Evidence of active infection or active hepatitis
2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
3. Previous allogeneic stem cell/bone marrow transplant
4. Pregnant or lactating patients

4 Exclusion criteria (Donor):

1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
2. Donors who are HIV+ or hepatitis B antigen +
3. History of allergic reaction to G-CSF
4. Female donors must be post-menopausal or have a negative pregnancy test

Primary outcomes:
measure: To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
timeFrame: no known
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ginna Laport
role: PRINCIPAL_INVESTIGATOR
References: