R Retreatment in 1st Relapsed DLBCL
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was Not yet recruiting
Information provided by:
Shanghai Jiao Tong University School of Medicine
First received: September 18, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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.
||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
Experimental: Rituximab in combination with ICE as salvage therapy
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
No Contacts or Locations Provided
No publications provided
||Shen, Zhixiang / Professor, Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 18, 2009
||September 18, 2009
||China: Ethics Committee
Keywords provided by Shanghai Jiao Tong University School of Medicine:
Diffuse large B cell lymphomas
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs