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A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine

Phase 1/Phase 2
Open (Enrolling)
Graft Versus Host Disease

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Trial Information

A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine

OBJECTIVES: I. Determine the maximum tolerated dose, toxicity, and efficacy of fludarabine
in patients with steroid resistant chronic graft versus host disease.

OUTLINE: This is a dose escalation study. Phase I: Patients receive fludarabine IV over less
than 30 minutes for 1-3 days. Treatment repeats every 4 weeks for up to 4 courses in the
absence of relapse of underlying disease, malignancy, graft rejection, or unacceptable
toxicity. Patients with progressive graft versus host disease after completion of 3 courses
are taken off study. Patients with complete response are taken off study. Patients with
partial response may continue treatment at the immediate prior dose level. Cohorts 3-6
patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose limiting toxicity. Phase II: Patients receive fludarabine at the MTD from
phase I of the study.

PROJECTED ACCRUAL: A total of 15-27 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or clinically proven chronic graft versus host
disease (GVHD) that has failed to respond to at least 1 month of treatment with the
following: Steroids (greater than 0.5 mg/kg/day) AND Cyclosporine or a cytotoxic agent
(azathioprine or mercaptopurine) OR Other experimental treatment (such as chloroquine) All
allogeneic bone marrow or peripheral blood stem cell transplantation patients eligible
regardless of underlying disease for which transplantation was performed if: At least 45
days since prior transplantation No relapse of underlying disease No loss of donor
hematopoiesis Patients with a rapid deterioration of GVHD that is considered life
threatening if not controlled are eligible after receiving high dose steroids (greater
than 1 mg/kg/day) for at least 10 days

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,300/mm3
Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater
than 2 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: No
other concurrent cytotoxic drugs Endocrine therapy: Concurrent steroids allowed but must
be tapered to less than 0.5 mg/kg/day of prednisone or equivalent prior to starting study
drug (if symptomatic flare develops during taper, patients may continue on the lowest dose
thought to produce stabilization) Radiotherapy: Not specified Surgery: Not specified
Other: Concurrent cyclosporine and other nonmyelosuppressive drugs allowed No concurrent
myelosuppressive agents (azathioprine, mercaptopurine)

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • Graft vs Host Disease