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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


Phase 2
N/A
55 Years
Not Enrolling
Both
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)

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Trial Information

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


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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.

Outcome Time Frame:

no known

Safety Issue:

No

Principal Investigator

Ginna Laport

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT142

NCT ID:

NCT00185523

Start Date:

May 2002

Completion Date:

April 2009

Related Keywords:

  • 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)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Promyelocytic, Acute
  • Acute Disease
  • Chronic Disease

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317