LymphomasPhase 2NCT00980304
R Retreatment in 1st Relapsed DLBCL
A Phase 2 study testing Rituximab in people with Lymphomas, run by Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphomas
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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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 ).
- 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
About this study
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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab in combination with ICE as salvage therapy | Experimental | Not described Receives: Drug: Rituximab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomasStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980304
- Sponsor's protocol ID
- ML22515
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00980304
- Acronym / sponsor ID
- ML22515
- Conditions
- Lymphomas
- Keywords
- Diffuse large B cell lymphomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab in combination with ICE as salvage therapy | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab | Drug | Rituximab in combination with ICE as salvage therapy |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Lymphomas, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.