Clinical trial · Interventional
The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma
NCT00440583CI-TRIAL-00016744completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy followed by Zevalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemotherapy followed by Zevalin
- description
- 6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin
- interventionNames
- Drug: chemotherapy followed by Zevalin
Primary outcomes (1)
- measure
- - Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin.
- timeFrame
- 2 year
Secondary outcomes (2)
- measure
- Determine the response duration(time to progression)after therapy.
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, CD 20 positive diffuse large B-cell lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV disease at the initial diagnosis. * Bidimensionally measurable disease * Age 18 - 75 Years * Performance status Zubrod 0-2 * Less than 20,000/mcL circulating lymphoid cells on WBC differential count * Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available * Needle aspiration or cytology are not considered adequate * No clinical evidence of CNS involvement by lymphoma * No prior diagnosis of indolent lymphoma * No histologic transformation * Life expectancy : Not specified * Hepatic : Not specified * Renal : Not specified * Cardiovascular * Ejection fraction ≥ 45% by MUGA OR * No significant abnormalities by echocardiogram * Pulmonary : No requirement for continuous supplemental oxygen * Other * All adult patients of reproductive potential must use contraception during and for 6 months after completion of study treatment * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of the cervix * No known HIV positive * Written informed consent * PRIOR CONCURRENT THERAPY: * Biologic therapy : No prior antibody therapy for lymphoma * Chemotherapy : 6 cycles of CHOP * Endocrine therapy : Not specified * Radiotherapy : No prior radiotherapy for lymphoma * Surgery : No prior solid organ transplantation Exclusion Criteria: * Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial treatment of DLBCL * Positive HIV serology * Positive serology of HCV with the presence of HCV RNA of chronic hepatitis * Positive serology of HBV with the presence of HBV RNA of chronic hepatitis * Serum creatinine or bilirubin \> 2.5 x upper limit of normal * Active uncontrolled infection * Concurrent severe and/or uncontrolled medical disease which could compromise the participation in the study * Patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells * Patients with platelet counts \<100,000/µl or neutrophil counts \< 1500/µl
References
Publications (0)
Data not yet available
No reference posted for this study.