Status:
UNKNOWN
R Retreatment in 1st Relapsed DLBCL
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Lymphomas
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
- Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease)
- Life expectancy \< 3 months
- Treatment within a clinical trial within 30 days prior to trial entry
- Women who are breast feeding, are not using effective contraception, are pregnant
- Patients under tutelage
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00980304
Last Update
September 21 2009
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