Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00185523
• Other study ID #: BMT142
• Secondary ID: 7814912570
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 14, 2016
• Start date: May 2002
• Est. completion date: April 2009

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 55 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Disease
• Chronic Disease
• Leukemia
• Leukemia Acute Lymphoid Leukemia (ALL)
• Leukemia Acute Myeloid Leukemia (AML)
• Leukemia Acute Promyelocytic Leukemia (APL)
• Leukemia Chronic Lymphocytic Leukemia (CLL)
• Leukemia Chronic Myelogenous Leukemia (CML)
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Promyelocytic, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• Allogeneic hematopoietic cell transplantation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.		no known	No