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

June 14, 2016 updated by: Stanford University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
Time Frame: no known
no known

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Ginna Laport, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT142
  • 78149
  • NCT00185523
  • 12570 (Other Identifier: Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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