NCT00980304
Unknown
Phase 2
A Multicenter, Open Label, Phase II Trial of Rituximab in Combination With ICE as Salvage Therapy in the Relapsed DLBCL Patients After 1st Line Induction Treatment of 6-8 Cycles of RCHOP-LIKE Chemo
Shanghai Jiao Tong University School of Medicine0 sitesSeptember 21, 2009
Overview
- Phase
- Phase 2
- Intervention
- Rituximab
- Conditions
- Lymphomas
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment.
- •Disease relapsed no earlier than 6 months after prior induction treatment.
- •Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
- •ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
- •Known IPI at time of diagnosis (prior to induction therapy)
- •Age ≥18 years and \<65 y
- •Life expectancy of \> 3 months
- •Be willing and able to comply with the protocol for the duration of the study
- •Agree to use effective contraception for the entire treatment period and during the 12 months thereafter
- •Patient's written informed consent
Exclusion Criteria
- •More than one prior chemoimmunotherapy regimen.
- •Histologies other than DLBCL according to the WHO/REAL classification
- •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.
- •Major surgery, other than diagnostic surgery, within the last 4 weeks.
- •Evidence of CNS involvement patients
- •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
- •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 ).
- •HIV-positive patients.
- •Contraindication to the investigational medication
- •Active viral hepatitis, specifically HBV or HCV infection
Arms & Interventions
Rituximab in combination with ICE as salvage therapy
Intervention: Rituximab
Outcomes
Primary Outcomes
Not specified
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