R Retreatment in 1st Relapsed DLBCL
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Rituximab in combination with ICE as salvage therapy
|
Drug: Rituximab
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment.
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Disease relapsed no earlier than 6 months after prior induction treatment.
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Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
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ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
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Known IPI at time of diagnosis (prior to induction therapy)
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Age ≥18 years and <65 y
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Life expectancy of > 3 months
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Be willing and able to comply with the protocol for the duration of the study
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Agree to use effective contraception for the entire treatment period and during the 12 months thereafter
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Patient's written informed consent
Exclusion Criteria:
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More than one prior chemoimmunotherapy regimen.
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Histologies other than DLBCL according to the WHO/REAL classification
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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.
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Major surgery, other than diagnostic surgery, within the last 4 weeks.
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Evidence of CNS involvement patients
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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
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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 ).
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HIV-positive patients.
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Contraindication to the investigational medication
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Active viral hepatitis, specifically HBV or HCV infection
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Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease)
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Life expectancy < 3 months
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Treatment within a clinical trial within 30 days prior to trial entry
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Women who are breast feeding, are not using effective contraception, are pregnant
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Patients under tutelage
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML22515