Know Cancer

or
forgot password

Gemtuzumab Ozogamicin (GO), Fludarabine, And Low-Dose TBI Followed By Donor Stem Cell Transplantation For Patients With Advanced Acute Myeloid Leukemia Or Myelodysplastic Syndrome


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

Gemtuzumab Ozogamicin (GO), Fludarabine, And Low-Dose TBI Followed By Donor Stem Cell Transplantation For Patients With Advanced Acute Myeloid Leukemia Or Myelodysplastic Syndrome


OBJECTIVES: I. Determine the response and disease-free survival at 1 year of patients with
advanced acute myeloid leukemia or myelodysplastic syndrome treated with gemtuzumab
ozogamicin, fludarabine, and total body irradiation followed by allogeneic peripheral blood
stem cell or bone marrow transplantation with cyclosporine and mycophenolate mofetil. II.
Determine the leukemic blast clearance from the blood and marrow in these patients treated
with this regimen. III. Determine the safety and pharmacokinetics of gemtuzumab ozogamicin
as part of this regimen in these patients. IV. Determine the incidence of donor stem cell
engraftment in these patients. V. Determine the incidence and severity of graft-versus-host
disease in these patients treated with this regimen. VI. Determine whether donor lymphocyte
infusion can be safely used in the patients with mixed or full donor chimerism to eliminate
persistent or progressive disease.

OUTLINE: Patients receive gemtuzumab ozogamicin IV over 2 hours on days -21 (first 5
patients) or -14 (subsequent patients) and -7, and fludarabine IV over 2 hours on days -4 to
-2. Patients undergo total body irradiation followed by infusion of allogeneic peripheral
blood stem cells or bone marrow on day 0. Patients receive oral or IV cyclosporine 2-3 times
daily on days -3 to 56 (if related donor) or 100 (if unrelated donor) and oral or IV
mycophenolate mofetil twice daily on days 0 to 27 (if related donor) or 40 (if unrelated
donor). Patients receive 2 doses of intrathecal methotrexate prior to transplant and an
additional 4 doses after transplant. Patients with cerebral spinal fluid (CSF) positive for
malignant cells instead receive intrathecal cytarabine, methotrexate and hydrocortisone
prior to transplant twice weekly until CSF blasts clear. Patients with persistent or
recurrent disease after transplant may receive up to 3 donor lymphocyte infusions if
graft-versus-host disease is less than grade II and they have greater than 5% donor CD3
cells. Patients are followed at 6 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory acute myeloid leukemia CD33
positive Greater than 5% morphologically identified blasts in the marrow OR Diagnosis of
myelodysplastic syndrome CD33 positive Greater than 5% morphologically identified blasts
in the marrow (refractory anemia with excess blasts (RAEB) and RAEB in transformation)
Must have donor who meets the following criteria: HLA-A, B, C, DRB1 and DQB1 identical or
mismatched for no more than 1 allelic or cross-reactive antigen Under 75 years of age

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
Not specified Hematopoietic: WBC no greater than 30,000/mm3 (leukophereses or hydroxyurea
allowed) Hepatic: Bilirubin no greater than 2 times upper limit of normal No synthetic
dysfunction No severe cirrhosis Renal: Not specified Cardiovascular: No symptomatic
coronary artery disease No cardiac failure requiring therapy Pulmonary: DLCO at least 35%
OR Receiving supplementary continuous oxygen Other: No uncontrolled infection No other
diseases that would severely limit life expectancy Not pregnant or nursing Fertile
patients must use effective contraception during and for 1 year after study

PRIOR CONCURRENT THERAPY: No post-transplant growth factors during and for 1 month after
mycophenolate mofetil administration

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1555.00

NCT ID:

NCT00008151

Start Date:

October 2000

Completion Date:

July 2002

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109