R Retreatment in 1st Relapsed DLBCL

Shanghai Jiao Tong University School of Medicine

Overview

It is a phase II , multicenter, open label clinical trial. Only the relapsed DLBCL patients after 1st line induction treatment of 6\~8 cycles of RCHOP-like chemo will be enrolled to receive 3 cycles of RICE as salvage therapy. After treatment each patient should be followed up for 2 years.

Study Type

INTERVENTIONAL

Conditions

Lymphomas

Interventions

RituximabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment. 2. Disease relapsed no earlier than 6 months after prior induction treatment. 3. Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy) 4. ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV ) 5. Known IPI at time of diagnosis (prior to induction therapy) 6. Age ≥18 years and \<65 y 7. Life expectancy of \> 3 months 8. Be willing and able to comply with the protocol for the duration of the study 9. Agree to use effective contraception for the entire treatment period and during the 12 months thereafter 10. Patient's written informed consent Exclusion Criteria: 1. More than one prior chemoimmunotherapy regimen. 2. Histologies other than DLBCL according to the WHO/REAL classification 3. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma or carcinoma in situ of the cervix within the last 5 years. 4. Major surgery, other than diagnostic surgery, within the last 4 weeks. 5. Evidence of CNS involvement patients 6. Unacceptable hematologic status at baseline prior to study start below any of the values listed: WBC: \<3 x 109/L; absolute neutrophil count (segmented + bands) \<1.5 x 109/L; platelets: \<100 x109/L 7. Abnormal liver function tests prior to study start above any of the values listed: serum bilirubin \>2 mg/dL (30 mmol/L); ALAT or ASAT \>2.5 x upper limit of normal range; or Abnormal renal function (serum creatinine \> 150 μmol/L ). 8. HIV-positive patients. 9. Contraindication to the investigational medication 10. Active viral hepatitis, specifically HBV or HCV infection 11. Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease) 12. Life expectancy \< 3 months 13. Treatment within a clinical trial within 30 days prior to trial entry 14. Women who are breast feeding, are not using effective contraception, are pregnant 15. Patients under tutelage

Data from ClinicalTrials.gov

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