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

NCT00185523 | Terminated

• 4 other identifiers: BMT14278149NCT0018552312570
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

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

  no known

Study Arms (2)

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

Interventions

Allogeneic hematopoietic cell transplantation PROCEDURE

AML and ALL in first or second remission; CML in first Chronic Phase or Accelerated Phase

Eligibility Criteria

• Age: 4 Weeks - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• acute myelogenous leukemia, 1st or 2nd remission
• acute lymphoblastic leukemia, 1st or 2nd remission
• 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.
• HLA identical family member
• Donor or guardian must be competent to give consent
• Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter

You may not qualify if:

• Evidence of active infection or active hepatitis
• Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
• Previous allogeneic stem cell/bone marrow transplant
• Pregnant or lactating patients
• Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
• Donors who are HIV+ or hepatitis B antigen +
• History of allergic reaction to G-CSF
• Female donors must be post-menopausal or have a negative pregnancy test

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia; Leukemia, Promyelocytic, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell

Study Officials

• Ginna Laport

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2002
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

US (1)