Overview

This trial is active, not recruiting.

Conditions graft versus host disease, recurrent adult acute lymphoblastic leukemia
Treatments prednisone, methylprednisolone, questionnaire administration
Phase phase 3
Sponsor Fred Hutchinson Cancer Research Center
Collaborator National Cancer Institute (NCI)
Start date June 2009
End date July 2013
Trial size 164 participants
Trial identifier NCT00929695, 2327.00, NCI-2010-00323, P01CA018029

Summary

This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see how well they work compared with standard-dose prednisone or methylprednisolone in treating patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids in treating acute graft-versus-host-disease

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone DeCortin
immunosuppressive drug
methylprednisolone Depo-Medrol
immunosuppressive drug
questionnaire administration
Ancillary studies
(Active Comparator)
Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.
prednisone DeCortin
immunosuppressive drug
methylprednisolone Depo-Medrol
immunosuppressive drug
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
time frame: At day 42 after initiation of treatment

Secondary Outcomes

Measure
Prednisone-associated Toxicity as Assessed by Hyperglycemia
time frame: Baseline and then through 42 days after starting treatment
Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
time frame: Baseline and through 100 days of treatment
Prednisone-associated Toxicity as Assessed by Myopathy
time frame: Baseline and then weekly until 42 days after starting treatment
Prednisone-associated Toxicity as Assessed by Hypertension
time frame: Baseline and then through 42 days after starting treatment
Prednisone-associated Toxicity as Assessed by Quality of Life
time frame: Baseline and then every other week until 42 days after starting treatment
Non-relapse Mortality
time frame: At 12 months after the start of prednisone therapy
Recurrent or Progressive Malignancy
time frame: At 12 months after the start of prednisone therapy
Progression to Grade III-IV Acute GVHD
time frame: At approximately 100 days after transplant
Secondary Therapy for Acute GVHD Beyond Prednisone
time frame: At approximately 100 days after transplant
Chronic Extensive GVHD
time frame: At 12 months after the start of prednisone therapy
Overall Survival
time frame: At 12 months after the start of prednisone therapy

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease
Principal investigator Marco Mielcarek
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.