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NCT Number: NCT00929695

Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease

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

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Key information

Conditions

Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

immunosuppressive drug

Other names: DeCortin, Deltra

methylprednisolone

Drug

immunosuppressive drug

Other names: Depo-Medrol, Medrol, MePRDL, Solu-Medrol, Wyacort

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

    Time frame: At day 42 after initiation of treatment

    The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.

Secondary outcomes

  1. Prednisone-associated Toxicity as Assessed by Hyperglycemia

    Time frame: Baseline and then through 42 days after starting treatment

    Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.

  2. Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

    Time frame: Baseline and through 100 days of treatment

    The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.

  3. Prednisone-associated Toxicity as Assessed by Myopathy

    Time frame: Baseline and then weekly until 42 days after starting treatment

    Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.

  4. Prednisone-associated Toxicity as Assessed by Hypertension

    Time frame: Baseline and then through 42 days after starting treatment

    The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.

  5. Prednisone-associated Toxicity as Assessed by Quality of Life

    Time frame: Baseline and then every other week until 42 days after starting treatment

    Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.

  6. Non-relapse Mortality

    Time frame: At 12 months after the start of prednisone therapy

    Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.

  7. Recurrent or Progressive Malignancy

    Time frame: At 12 months after the start of prednisone therapy

    Percentage of relapse estimated by cumulative incidence methods

  8. Progression to Grade III-IV Acute GVHD

    Time frame: At approximately 100 days after transplant

    Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.

  9. Secondary Therapy for Acute GVHD Beyond Prednisone

    Time frame: At approximately 100 days after transplant

    This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.

  10. Chronic Extensive GVHD

    Time frame: At 12 months after the start of prednisone therapy

    Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods

  11. Overall Survival

    Time frame: At 12 months after the start of prednisone therapy

    Percentage of patients surviving as estimated by Kaplan-Meier.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Jun 29, 2009
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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