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Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT

Not Enrolling
Hodgkin's Disease, Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

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Trial Information

Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT

Inclusion Criteria:

- Patient must be a recipient of aT cell depleted unrelated or HLA mis-matched related
HSCT for the treatment of a malignancy or immunodeficiency disease.

- Patients must have an ANC > or = to 1500 cells/ul on the day of first treatment.

- Patients with acute or chronic leukemia, or MDS prior to transplant must be in
remission defined as <5% blasts in the bone marrow.

- Patient with must be in remission.

- Patient must be Hepatitis B surface antigen negative pre transplant.

- Patients must have adequate cardiac function defined as a left ventricular ejection
fraction at rest of >50% documented pre-transplant.

- Patient may be of either gender and of any ethnic background.

- Patient may be of any age. There is no upper age restriction.

- Patients or their guardians must be able to understand the nature and risk of the
proposed study and be able to sign consent.

Exclusion Criteria:

- Karnofsky score <70%

- Female patients who are pregnant or lactating.

- Evidence of EBV-LPD or circulating EBV copy number >1000.

- Active uncontrolled bacterial or fungal infection.

- Prior history of Hepatitis B infection or Hepatitis B surface antigen positivity pre

- HIV-1,2 sero-positive patients.

- Patients or guardians not signing informed consent.

- Patients with prior allergic reaction to Rituximab or other murine monoclonal

- Patients taking other investigational agents under another protocol unless discussed
and approved in advance by Genentech and the IDEC Therapeutic Director.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLAmismatched related HSCT.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Trudy Small, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

December 2008

Related Keywords:

  • Hodgkin's Disease
  • Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Myelodysplastic Syndromes
  • Preleukemia



Memorial Sloan-Kettering Cancer Center New York, New York  10021