Know Cancer

or
forgot password

A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission


Phase 3
50 Years
75 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Leukemia, Acute Myeloid Leukemia (AML)

Thank you

Trial Information

A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission


Inclusion Criteria:



Both genders and individuals from all ethnic groups will be eligible.

1. Patients greater than or equal to 50 years of age and less than or equal to 75 years
of age.

2. Patients with de novo AML based on FAB and WHO criteria.

3. Patients with intermediate or unfavorable cytogenetic abnormalities based on SWOG
Cytogenetic Criteria.

4. Patients achieving a 1st morphologic CR, or CRp (a complete remission but with low
platelets) following one or two courses of induction therapy. (See definition of CR
on page 6.) CR must be documented no more than 8 weeks prior to the date of
enrollment.

5. Patients fit for nonmyeloablative transplantation or best treatment.

6. Patients able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

1. Patients with AML with favorable cytogenetic features based on SWOG Cytogenetic
Criteria.

2. Patients not in a Complete Remission at time of enrollment.

3. Patients with treatment-related or MDS-related AML.

4. CR documented >8 weeks prior to date of enrollment.

5. Patients with active CNS disease as identified by positive CSF cytospin at time of
enrollment.

6. Patients with prior or concurrent malignancies except localized non-melanoma skin
malignancies or treated cervical carcinoma in situ. Cancer treated with curative
intent <5 years previously will not be allowed. Cancer treated with curative intent
>5 years previously will be allowed. Patients with low grade lymphomas are eligible
as long as they have not and do not require active treatment for control of their
disease.

7. Patients planned for allogeneic transplant using a full-dose conditioning,
irrespective of knowledge of donor status.

8. Patients whose life expectancy is severely limited (<1 year) by diseases other than
malignancy.

9. Karnofsky Performance Score <60.

10. Patients who are pregnant or breastfeeding.

11. Patients who are HIV seropositive.

12. Patients who have an uncontrolled infection (presumed or documented) with progression
after appropriate therapy for greater than one month.

13. Patients with symptomatic coronary artery disease, uncontrolled congestive heart
failure. Left Ventricular Ejection Fraction is not required to be measured, however
if it is measured, patient is excluded if ejection fraction is <30%.

14. Patients requiring supplementary continuous oxygen. DLCO is not required to be
measured, however if it is measured, patient is excluded if DLCO <35%.

15. Patients with clinical or laboratory evidence of liver disease will be evaluated for
the cause of liver disease, its clinical severity in terms of liver function and
histology, and for the degree of portal hypertension. Patients with any of the
following liver function abnormalities will be excluded:

1. Fulminant liver failure.

2. Cirrhosis with evidence of portal hypertension or bridging fibrosis.

3. Alcoholic hepatitis.

4. Esophageal varices.

5. A history of bleeding esophageal varices.

6. Hepatic encephalopathy.

7. Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the
prothrombin time.

8. Ascites related to portal hypertension.

9. Chronic viral hepatitis with total serum bilirubin >3 mg/dL.

10. Symptomatic biliary disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival defined as the date of documented complete remission (CR) until the dte of the latest follow-up or death by any cause

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Louis Fehrenbacher

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southern California Kaiser Permanente Group

Authority:

United States: Institutional Review Board

Study ID:

BMT190

NCT ID:

NCT00568633

Start Date:

August 2007

Completion Date:

December 2017

Related Keywords:

  • Leukemia, Myeloid
  • Leukemia
  • Acute Myeloid Leukemia (AML)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Cedars-Sinai Medical CenterLos Angeles, California  90048
Stanford University School of MedicineStanford, California  94305-5317
Kaiser Permanente Northern CaliforniaOakland, California  94612
West Virginia University HospitalMorgantown, West Virginia  26506-9162
Univeristy of California Davis Medical CenterSacramento, California  95817