R Retreatment in 1st Relapsed DLBCL

September 18, 2009 updated by: Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment.
  2. Disease relapsed no earlier than 6 months after prior induction treatment.
  3. Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
  4. ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
  5. Known IPI at time of diagnosis (prior to induction therapy)
  6. Age ≥18 years and <65 y
  7. Life expectancy of > 3 months
  8. Be willing and able to comply with the protocol for the duration of the study
  9. Agree to use effective contraception for the entire treatment period and during the 12 months thereafter
  10. Patient's written informed consent

Exclusion Criteria:

  1. More than one prior chemoimmunotherapy regimen.
  2. Histologies other than DLBCL according to the WHO/REAL classification
  3. 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.
  4. Major surgery, other than diagnostic surgery, within the last 4 weeks.
  5. Evidence of CNS involvement patients
  6. 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
  7. 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 ).
  8. HIV-positive patients.
  9. Contraindication to the investigational medication
  10. Active viral hepatitis, specifically HBV or HCV infection
  11. Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease)
  12. Life expectancy < 3 months
  13. Treatment within a clinical trial within 30 days prior to trial entry
  14. Women who are breast feeding, are not using effective contraception, are pregnant
  15. Patients under tutelage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab in combination with ICE as salvage therapy
Drug: Rituximab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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