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High-Dose Sequential Chemotherapy and Rituximab (R-HDS) in Patients With Systemic B-Cell Lymphoma With Central Nervous System Involvement at Diagnosis or Relapse

Phase 2
19 Years
65 Years
Open (Enrolling)
B-Cell Lymphomas

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Trial Information

High-Dose Sequential Chemotherapy and Rituximab (R-HDS) in Patients With Systemic B-Cell Lymphoma With Central Nervous System Involvement at Diagnosis or Relapse

Patients with aggressive B-cell lymphoma and involvement of the central nervous system at
diagnosis or relapse will be treated with a combination of high-dose methotrexate and
high-dose cytarabine, rituximab, and intrathecal depocyte followed by rituximab-high-dose
sequential chemotherapy supported by autologous tsem cell transplantation.

Inclusion Criteria:

1. Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell

2. CNS involvement (brain, meninges, cranial nerves, eyes, and/or spinal cord) at
diagnosis or relapse after conventional chemotherapy

3. Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination.
Neuroimaging alone is acceptable only when stereotactic biopsy is formally

4. Age 19-65 years

5. ECOG performance status 0-3

6. Adequate bone marrow (PLT > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3), renal
(creatinine clearance > 60 mL/min), cardiac (VEF > 50%), and hepatic function (total
serum bilirubin < 3 mg/dL, AST/ALT and gammaGT < 2.5 per upper normal limit value),
within 1 week prior to study start (unless the abnormality is due to lymphoma

7. Absence of symptomatic coronary artery disease, cardiac arrhythmias not well
controlled with medication or myocardial infarction within the last 6 months (New
York Heart Association Class III or IV heart disease)

8. Absence of HIV infection

9. No previous or concurrent malignancies with the exception of surgically cured
carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers
without evidence of disease at least from 5 years

10. Absence of any familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule

11. Female patients must be non-pregnant and non-lactating. Sexually active patients of
childbearing potential must implement adequate contraceptive measures during study

12. No treatment with other experimental drugs within the 6 weeks previous to enrolment

13. Give written informed consent prior to any study specific procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
without prejudice

Exclusion Criteria:

- NA

Type of Study:


Study Design:

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

Outcome Measure:

Event-free survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

Andrés J. Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Scientific Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

January 2012

Related Keywords:

  • B-Cell Lymphomas
  • B-cell lymphomas
  • lymphomatous meningitis
  • liposomal cytarabine
  • autologous transplant
  • CNS involvement
  • Secondary CNS lymphomas
  • Lymphoma
  • Lymphoma, B-Cell