NCT00440583

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

5 years

First QC Date

February 26, 2007

Last Update Submit

January 28, 2015

Conditions

Diffuse Large B-cell Lymphoma

Keywords

CHOP-Z

Outcome Measures

Primary Outcomes (1)

  • - Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin.

    2 year

Secondary Outcomes (2)

  • Determine the response duration(time to progression)after therapy.

    2 year

  • Determine safety and tolerability of Yt90-Zevalin consolidation therapy.

    2 year

Study Arms (1)

chemotherapy followed by Zevalin

EXPERIMENTAL

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

Drug: chemotherapy followed by Zevalin

Interventions

chemotherapy followed by ZevalinDRUG

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

chemotherapy followed by Zevalin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +13 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Surapol Issaragrisil, M.D.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

September 1, 2006

Primary Completion

September 1, 2011

Study Completion

May 1, 2012

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

TH(1)