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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00185523
First received: September 12, 2005
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
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)
 Procedure: Allogeneic hematopoietic cell transplantation
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors. [ Time Frame: no known ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: May 2002
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CML in first Chronic Phase or Accelerated Phase
Busulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs** Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion
 Procedure: Allogeneic hematopoietic cell transplantation
AML and ALL in first or second remission
FTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion
 Procedure: Allogeneic hematopoietic cell transplantation

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

Ages Eligible for Study:   up to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185523

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ginna Laport Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00185523     History of Changes
Other Study ID Numbers: BMT142, 78149, 12570
Study First Received: September 12, 2005
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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
Leukemia, B-Cell
Acute Disease
Chronic Disease
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013