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

NCT00929695 | Completed Phase 3 Results

• 3 other identifiers: 2327.00NCI-2010-00323P01CA018029
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Graft Versus Host Disease; Recurrent Adult Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

  At day 42 after initiation of treatment

Secondary Outcomes (11)

• Prednisone-associated Toxicity as Assessed by Hyperglycemia

  Baseline and then through 42 days after starting treatment

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

  Baseline and through 100 days of treatment

• Prednisone-associated Toxicity as Assessed by Myopathy

  Baseline and then weekly until 42 days after starting treatment

• Prednisone-associated Toxicity as Assessed by Hypertension

  Baseline and then through 42 days after starting treatment

• Prednisone-associated Toxicity as Assessed by Quality of Life

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

Study Arms (2)

Arm I (Low-dose)

EXPERIMENTAL

Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.

Drug: prednisone; Drug: methylprednisolone; Other: questionnaire administration

Arm II (Standard-dose)

ACTIVE COMPARATOR

Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.

Drug: prednisone; Drug: methylprednisolone; Other: questionnaire administration

Interventions

prednisone DRUG

immunosuppressive drug

Also known as: DeCortin, Deltra

Arm I (Low-dose); Arm II (Standard-dose)

methylprednisolone DRUG

immunosuppressive drug

Also known as: Depo-Medrol, Medrol, MePRDL, Solu-Medrol, Wyacort

Arm I (Low-dose); Arm II (Standard-dose)

questionnaire administration OTHER

Ancillary studies

Arm I (Low-dose); Arm II (Standard-dose)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Immune System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols

Results Point of Contact

• Title: Marco Mielcarek
• Organization: Fred Hutchinson Cancer Research Center

mmielcar@fhcrc.org

206-667-2827

Study Officials

• Marco Mielcarek

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: December 14, 2015
• Last Updated: August 21, 2017
• Results First Posted: October 9, 2014

Record last verified: 2017-07

Locations

US (1)