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A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease


Phase 3
N/A
N/A
Open (Enrolling)
Both
Graft Versus Host Disease, Recurrent Adult Acute Lymphoblastic Leukemia

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Trial Information

A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease


OBJECTIVES:

I. To determine whether a lower starting dose of prednisone for treatment of newly diagnosed
acute GVHD results in decreased prednisone exposure without compromising overall survival.

II. To estimate the magnitude of clinical benefit associated with the reduction in
prednisone exposure.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (Low-dose; prednisone-equivalent dose at initiation of treatment of 0.5 mg/kg/day or
1.0 mg/kg/day; stratified according to initial symptom severity): Patients receive low-dose
prednisone or methylprednisolone once or twice daily in the absence of disease progression
or unacceptable toxicity.

ARM II (Standard-dose; prednisone-equivalent dose at initiation of treatment of 1.0
mg/kg/day or 2.0 mg/kg/day; stratified according to initial symptom severity): Patients
receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 year and then annually
thereafter.


Inclusion Criteria:



- Patients with newly diagnosed acute GVHD (>= grade IIa) for whom, in the judgment of
the attending physician, initial treatment with systemic glucocorticoids is indicated

- Patient or guardian able and willing to provide informed consent

Exclusion Criteria:

- Hallmarks of chronic GVHD

- GVHD after donor lymphocyte infusion (DLI)

- Patient unwilling to remain in Seattle under the care of the Fred Hutchinson Cancer
Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA) through day 42 after the
start of treatment for GVHD

- Uncontrolled infection or other underlying comorbidity (i.e. severe psychiatric
illness) that precludes the use of "standard-dose" prednisone

- Recent diagnosis of recurrent or progressive malignancy that precludes the use of
"standard-dose" prednisone

- Any prior systemic therapy for acute GVHD (Patients may receive up to 2 doses of
low-dose prednisone prior to randomization; low-dose prednisone is defined as 0.5
mg/kg/dose for patients who present with grade IIa GVHD and 1 mg/kg/dose for those
who present with grade IIb-IV GVHD)

- Enrollment on Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) trial
0802

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

>= 33% reduction of cumulative prednisone dose with lower-dose prednisone compared to those given standard-dose prednisone

Outcome Description:

Demonstrated in a prospective fashion.

Outcome Time Frame:

At day 42 after initiation of treatment

Safety Issue:

No

Principal Investigator

Marco Mielcarek

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

2327.00

NCT ID:

NCT00929695

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109