Back to resultsR Retreatment in 1st Relapsed DLBCL
Primary Purpose
Lymphomas
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional trial for Lymphomas focused on measuring Diffuse large B cell lymphomas
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab in combination with ICE as salvage therapy
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00980304
First Posted
September 18, 2009
Last Updated
September 18, 2009
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00980304
Brief Title
R Retreatment in 1st Relapsed DLBCL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphomas
Keywords
Diffuse large B cell lymphomas
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
Rituximab in combination with ICE as salvage therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
12. IPD Sharing Statement
Learn more about this trial
R Retreatment in 1st Relapsed DLBCL
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