R Retreatment in 1st Relapsed DLBCL

NCT00980304 | Unknown Phase 2

• 1 other identifier: ML22515
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphomas

Keywords

Diffuse large B cell lymphomas

Study Arms (1)

Rituximab in combination with ICE as salvage therapy

EXPERIMENTAL

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab in combination with ICE as salvage therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Lymphoma; Dendritic Cell Sarcoma, Interdigitating

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Last Updated: September 21, 2009

Record last verified: 2009-09