This Trial is a Safety and Feasibility Study of Combination of State of the Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Testicular Diffuse Large B-cell Lymphoma

This study is currently recruiting participants.
Verified July 2012 by International Extranodal Lymphoma Study Group (IELSG)

First Received on July 23, 2009.  
Last Updated on July 6, 2012  
History of Changes
This Clinical Trial Sponsored By: International Extranodal Lymphoma Study Group (IELSG)
Information provided by (Responsible Party): International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00945724
 

Purpose for Clinical Trial

This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.

Condition Study Intervention Clinical Trial Phase
Primary Testicular Diffuse Large B-cell Lymphoma Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone Sodium Phosphate
Cytarabine
Prednisolone phosphate
Vincristine sulfate
Methylprednisolone Sodium Succinate
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Rituximab

U.S. FDA Resources

Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Estimated Enrollment: 35
Study Start Date: April 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate

    WEEKS 1-15 – 6 cycles of CHOP i.v. on days 1 to 5, to be repeated q 21 days cyclophosphamide 750 mg/m2 doxorubicin 50 mg/m2 vincristine 1.4 mg/m2 prednisone 40 mg/m2

    • Rituximab i.v. 375 mg/m2 on day 0 or day 1
    • Intrathecal chemotherapy: Depocyte®, 50 mg on day 0 of cycles 2, 3, 4, 5 of CHOP WEEKS 18-22
    • Methotrexate i.v. 1.5 g/m2 q 14 days x 2 FROM WEEKS 24
    • Scrotal prophylactic radiotherapy or involved field radiotherapy (but can be planned concomitantly to R-CHOP in patients with bilateral disease)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with primary testicular lymphoma at diagnosis. Histological subtype included into the study is only Diffuse Large B Cell Lymphoma (Attachment 2: WHO classification of lymphoma).
  2. Orchiectomy is mandatory, before enrolment of the patient into the study.
  3. Orchiectomy should be performed within 2 months before study entry.
  4. Age 18-80
  5. Untreated patients
  6. Ann Arbor Stage IE and IIE. Bilateral testicular involvement at presentation will not be considered Stage IV. These patients may be included into the study and the final Ann Arbor stage (I or II) will be determined by the extent of nodal disease.
  7. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
  8. Adequate haematological counts: ANC > 1.0 x 109/L and PLTs count > 75 x 109/L
  9. Cardiac ejection fraction ≥ 45% by MUGA scan or echocardiography
  10. Non peripheral neuropathy or any active non-neoplastic CNS disease.
  11. No other major life-threatening illnesses that may preclude chemotherapy
  12. Conjugated bilirubin ≤ 2 x ULN.
  13. Alkaline phosphatase and transaminases ≤ 2 x ULN.
  14. Creatinine clearances ≥ 45 ml/min.
  15. HIV negativity
  16. HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  17. HCV negativity with the exception of patients with no signs of active chronic

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