Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Lymphomas

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

N/A

Authority:

China: Ethics Committee

Study ID:

ML22515

NCT ID:

NCT00980304

Start Date:

Completion Date:

Related Keywords:

  • Lymphomas
  • Diffuse large B cell lymphomas
  • Lymphoma

Name

Location