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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
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00980304
First received: September 18, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lymphomas
 Drug: Rituximab
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Arms Assigned Interventions
Experimental: Rituximab in combination with ICE as salvage therapy Drug: Rituximab

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shen, Zhixiang / Professor, Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
ClinicalTrials.gov Identifier: NCT00980304     History of Changes
Other Study ID Numbers: ML22515
Study First Received: September 18, 2009
Last Updated: September 18, 2009
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Diffuse large B cell lymphomas

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013