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Ofatumumab in Combination With Glucocorticoids for Primary Therapy of Chronic Graft Versus Host Disease

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

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Trial Information

Ofatumumab in Combination With Glucocorticoids for Primary Therapy of Chronic Graft Versus Host Disease

This is a phase I-II trial to examine the safety and efficacy of prednisone and escalating
dose of ofatumumab for the primary therapy of chronic GVHD.

Inclusion Criteria:

- HCT recipients newly requiring systemic glucocorticoid therapy for chronic GVHD

- Patients can be enrolled and begin study therapy with ofatumumab within 14 days from
initiation of 1 mg/kg prednisone for therapy of chronic GVHD.

Exclusion Criteria:

- Relapse of primary hematologic malignancy that served as indication for HCT.

- Previous systemic glucocorticoid therapy for chronic GVHD.

- Prior systemic glucocorticoid therapy for acute GVHD is permitted

- Prior or ongoing systemic immune suppressive agents (including, but not limited to
common examples such as calcineurin inhibitors, sirolimus, mycophenolate mofetil)
provided for either prevention or treatment of acute GVHD are permitted and part of
routine standard of care

- Current active hepatic or biliary disease (with exception of liver disease secondary
to chronic GVHD, or patients with Gilbert's syndrome, asymptomatic gallstones, or
stable chronic liver disease per investigator assessment)

- Patients with abnormal liver function tests due to chronic GVHD are specifically not
excluded from the study. This is a common manifestation of chronic GVHD, and thus a
major target for the study therapy.

- Treatment with experimental therapy within 5 terminal half lives or 4 weeks prior to
enrollment, whichever is longer

- Other past or current solid tumor malignancy

- Subjects who have been free of malignancy for at least 5 years, or have a history of
completely resected non-melanoma skin cancer, or successfully treated in situ
carcinoma are eligible.

- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months
prior to start of therapy.

- Uncontrolled infectious complications not responsive to appropriate antimicrobial

- History of significant cerebrovascular disease (i.e. stroke or TIA) in the past 6
months or ongoing event with active symptoms or sequelae

- HIV positivity

- Uncontrolled, current significant cardiac disease including unstable angina, acute
myocardial infarction within six months prior to randomization, congestive heart
failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the
exception of extra systoles or minor conduction abnormalities.

- Patients with history of cardiac disease, such as coronary disease, arrhythmia or
congestive heart failure that are on appropriate medical therapy and without evidence
of current decompensation are eligible.

- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease which in the opinion of the investigator may represent a risk for
the patient.

- Those patients with medical conditions that are controlled with medical therapy are

- Clinically active Hepatitis B defined as positive HBsAg; or positive HBcAb with
detectable HBV DNA viral load. Patients who are HBcAb with undetectable HBV DNA
viremia are eligible.

- Positive serology for hepatitis C (HC) defined as a positive test for HCAb and
confirmed by HC RIBA or HCV RNA viral load

- Screening laboratory value exclusion criteria:

- platelets < 50 x 10^9/L (patients with platelet counts > 50 x 10^9/L supported by
platelet transfusion are eligible)

- neutrophils < 1.0 x 10^9/L (patients with an absolute neutrophil count > 1.0 x 109/L
supported by growth factors are eligible)

- creatinine > 2.0 times upper normal limit

- total bilirubin >1.5 times upper normal limit (unless due to chronic GVHD)

- ALT > 2.0 times upper normal limit (unless due to chronic GVHD)

- alkaline phosphatase > 2.5 times upper normal limit (unless due to chronic GVHD)

- Pregnant or lactating women. Women of childbearing potential must have a negative
pregnancy test at screening.

- Women of child bearing potential must undergo pregnancy testing within 7 days of the
first dose of study therapy. Women must also undergo pregnancy test at 6 months after
the last dose.

- Women of childbearing potential, including women whose last menstrual period was less
than one year prior to screening, unable or unwilling to use adequate contraception
from study start to one year after the last dose of protocol therapy. Adequate
contraception is defined as hormonal birth control, intrauterine device, double
barrier method or total abstinence.

- Male subjects unable or unwilling to use adequate contraception methods from study
start to one year after the last dose of protocol therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose limiting toxicities

Outcome Description:

The dose limiting toxicity (DLT) will be CTCAE version 4.0 defined grade 4 adverse events attributable to the study agent ofatumumab

Outcome Time Frame:

within 28 days of initiation

Safety Issue:


Principal Investigator

Joseph Pidala, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:

MCC - 17071



Start Date:

November 2012

Completion Date:

October 2014

Related Keywords:

  • Chronic Graft Versus Host Disease
  • Graft vs. Host Disease
  • GVHD
  • cGVHD
  • Allogeneic Transplant
  • Ofatumumab
  • Graft vs Host Disease



H.Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612