A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor


Phase 2
N/A
55 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor


OBJECTIVES:

- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell
transplantation reduces the incidence of non-leukemic mortality in patients with acute
leukemia.

- Determine the kinetics and durability of engraftment after treatment with this regimen
in these patients.

- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.

- Determine the leukemia-free survival of patients treated with this regimen.

OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then
undergo leukapheresis on days -1 and 0.

Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2
doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients
also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic
peripheral blood stem cells on day 0.

PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Primary acute leukemia beyond first remission

- High-risk acute myelogenous leukemia

- Acute lymphoblastic leukemia in first remission

- Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles

- No HLA-matched identical sibling or haploidentical relative incompatible for 0
or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype

- No leukoencephalopathy

PATIENT CHARACTERISTICS:

Age:

- 55 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- SGOT no greater than 2 times normal

- Hepatitis B surface antigen negative

- No prior hepatitis C

Renal:

- No impaired renal function

- Creatinine less than 2 times normal

Cardiovascular:

- No symptomatic cardiac disease

Pulmonary:

- No active pulmonary disease

- DLCO at least 60% predicted

Other:

- HIV negative

- No disease or other malignancy that severely limits life expectancy

- No severe or life-threatening infection within the past 2 weeks

- No history of septate fungal infection or disseminated candidiasis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow or peripheral blood stem cell transplantation

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy greater than 3,000 cGy to whole brain

- No prior radiotherapy of 1,500 cGy to chest or abdomen

- At least 6 months since prior involved-field radiotherapy to chest or abdomen

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Claudio Anasetti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1099.00

NCT ID:

NCT00025545

Start Date:

March 1996

Completion Date:

October 2002

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • acute undifferentiated leukemia
  • secondary acute myeloid leukemia
  • Leukemia

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109