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

Stanford University

Status: Terminated

Conditions: Leukemia Acute Promyelocytic Leukemia (APL); Leukemia Acute Myeloid Leukemia (AML); Leukemia, Lymphocytic, Acute; Leukemia Acute Lymphoid Leukemia (ALL); Leukemia Chronic Lymphocytic Leukemia (CLL); Leukemia; Leukemia Chronic Myelogenous Leukemia (CML)

Treatments: Procedure: Allogeneic hematopoietic cell transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT00185523

78149

12570 (Other Identifier)

NCT00185523

BMT142

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 patients

Sex: All

Ages: 4 weeks to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

88 participants in 2 patient groups

CML in first Chronic Phase or Accelerated Phase

Description:

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

Treatment:

Procedure: Allogeneic hematopoietic cell transplantation

AML and ALL in first or second remission

Description:

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

Treatment:

Procedure: Allogeneic hematopoietic cell transplantation