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A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants


Phase 1/Phase 2
N/A
20 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants


OBJECTIVES:

Primary

- Determine the safety of a conditioning regimen without anti-thymocyte globulin
comprising total body irradiation, thiotepa, and fludarabine followed by
CD34-positive-selected haploidentical allogeneic peripheral blood stem cell
transplantation in young patients with life-threatening hematologic malignancies.

Secondary

- Determine the risk for severe graft-vs-host disease in patients treated with this
regimen.

- Determine the kinetics of immune reconstitution in patients treated with this regimen.

- Determine the risk for life-threatening infections in patients treated with this
regimen.

OUTLINE:

- Conditioning regimen: Patients 7 years of age and under undergo total body irradiation
twice daily on days -9 to -7. Patients over 7 years of age undergo total body
irradiation once on day -7. All patients receive fludarabine IV once daily on days -6
to -2 and thiotepa IV over 2 hours twice on day -5.

- CD34-positive (CD34+)-selected haploidentical allogeneic peripheral blood stem cell
transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and
2.

Patients with acute lymphoblastic leukemia or CNS disease also receive methotrexate
intrathecally twice before transplantation and 4 times after day 35 post-transplantation.
Male patients with lymphoid malignancies undergo additional radiotherapy to the testes.

After completion of study treatment, patients are followed for at least 100 days, at 1 year,
and then periodically thereafter.

PROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients > 7
years of age) will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of a life-threatening hematologic malignancy, including any of the
following:

- Acute leukemia advanced beyond first remission

- Acute leukemia in first remission* with very high-risk prognostic features,
including any of the following:

- Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)

- ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality

- Hypodiploid ALL

- Failed to achieve first remission within 1 month after induction therapy

- Secondary AML

- Myelodysplastic syndromes with International Prognostic Index score > 1

- Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be
approved by PCC

- Haploidentical family donor available

- No suitable HLA-matched related or unrelated donor available

- No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen
available

PATIENT CHARACTERISTICS:

Age

- Under 21

Performance status

- Not specified

Life expectancy

- At least 6 months

Hematopoietic

- Not specified

Hepatic

- SGPT and SGOT < 2 times upper limit of normal (ULN)*

- Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy

Renal

- Not specified

Cardiovascular

- Ejection fraction ≥ 45%

Pulmonary

- DLCO ≥ 60% of predicted

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No second bone marrow transplantation, after a first regimen containing total body
irradiation

- No concurrent growth factors until day 21 post-transplantation

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- See Biologic therapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Ann E. Woolfrey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1629.00

NCT ID:

NCT00112567

Start Date:

April 2003

Completion Date:

July 2007

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • childhood myelodysplastic syndromes
  • childhood acute lymphoblastic leukemia in remission
  • recurrent childhood acute myeloid leukemia
  • childhood acute myeloid leukemia in remission
  • secondary acute myeloid leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Seattle Cancer Care AllianceSeattle, Washington  98109