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Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndromes

Thank you

Trial Information

Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia


- Determine the therapeutic activity of 2 different doses of infliximab on peripheral
blood cell count and peripheral and bone marrow blast cell count in patients with low-
or intermediate-risk myelodysplastic syndromes.

- Determine the subjective and objective toxicity of these regimens in these patients.

- Determine the response rates (complete and partial response and hematological
improvement) in patients treated with these regimens.

- Determine the duration of response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to cytogenetics (good vs intermediate vs unknown due to failure), overall
International Prognostic Scoring System score (low [0] vs intermediate 1 [0.5-1.0] vs
intermediate 2 [1.5-2.0]), and participating center. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive infliximab IV on days 1, 15, 43, 71, 99, 127, 155, and 183 in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive a higher dose of infliximab as in arm I. Patients achieving
response (complete or partial response or hematological improvement) continue therapy
beyond day 183 in the absence of disease progression.

Patients are followed at 2 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 2 years.

Inclusion Criteria


- Confirmed diagnosis (within the past month) of low- or intermediate-risk
myelodysplastic syndromes (MDS) meeting all of the following criteria:

- No more than 10% bone marrow blasts (corresponding to refractory anemia [RA], RA
with ringed sideroblasts, or RA with excess blasts)

- Meets at least 1 of the following hematopoietic criteria:

- Hemoglobin no greater than 10 g/dL OR red blood cell transfusion dependent

- Neutrophil count no greater than 1,500/mm^3

- Platelet count no greater than 100,000/mm^3 OR platelet transfusion

- No poor cytogenetics (complex abnormalities or involvement of chromosome 7)

- Patients with unknown cytogenetics may be eligible provided reasonable
efforts have been made for determining the cytogenetic profile and the
results are considered a failure (e.g., normal karyotype [NN] with no more
than 10 metaphases)



- 18 and over

Performance status

- WHO 0-2

Life expectancy

- Not specified


- See Disease Characteristics


- No history of documented hepatitis C

- No documented active hepatitis B

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT less than 2.5 times ULN


- Creatinine less than 1.5 times ULN


- No New York Heart Association class III or IV heart disease

- No clinical history or evidence of congestive heart failure

- No severe cardiac dysfunction

- LVEF greater than 35%


- No prior or concurrent active or latent tuberculosis (TB)

- No evidence of prior or concurrent active TB (i.e., fibrotic or pleural
scarring, pulmonary nodules, mediastinal and/or hilar lymphadenopathy, upper
lobe volume loss, or cavitation) by chest x-ray

- Negative intradermal tuberculin skin test (i.e., induration less than 5 mm)

- No severe pulmonary dysfunction


- No prior or concurrent opportunistic infection (e.g., herpes zoster, cytomegalovirus,
Pneumocystic carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB)
within the past 6 months

- No concurrent severe (CTC grade III or IV) active, chronic, or recurrent infections

- No recent history of allergies

- HIV negative


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- No prior clinically significant adverse event to murine or chimeric proteins or
human/murine recombinant products

- No recent contact with an individual with active TB

- No poor medical risk due to other systemic disease

- No multiple sclerosis or other demyelinating disorder

- No peripheral neuropathy greater than CTC grade 1

- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix or nonmelanoma skin cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance


Biologic therapy

- No prior infliximab or other monoclonal antibodies

- At least 6 weeks since prior hematopoietic growth factors for MDS

- At least 3 months since prior therapy targeted at reducing tumor necrosis factor
(TNF) alpha (e.g., pentoxifylline, thalidomide, or etanercept)

- No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)

- No other concurrent drugs targeted at reducing TNF alpha (e.g., pentoxifylline,
thalidomide, or etanercept)


- Not specified

Endocrine therapy

- Not specified


- Not specified


- No prior solid organ transplantation

- Corneal transplantation more than 3 months ago allowed


- No prior randomization to this clinical trial

- At least 6 weeks since prior treatment for MDS (except supportive care)

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent therapeutic-dose nonsteroidal anti-inflammatory drugs (NSAIDs)

- Concurrent sporadic (no more than 3 tablets/week) over-the-counter NSAIDs

- Concurrent cardioprotective doses (80 mg/day or equivalent) of aspirin allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best response as measured by Cheson response criteria

Safety Issue:


Principal Investigator

Heinz Zwierzina, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University Innsbruck


United States: Federal Government

Study ID:




Start Date:

October 2003

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia with excess blasts
  • refractory anemia with ringed sideroblasts
  • refractory anemia
  • de novo myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia