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The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

chemotherapy followed by Zevalin

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring CHOP-Z

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy followed by Zevalin

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Determine safety and tolerability of Yt90-Zevalin consolidation therapy.

Full Information

NCT ID

NCT00440583

First Posted

February 26, 2007

Last Updated

January 28, 2015

Sponsor

Mahidol University

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00440583

Brief Title

The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP

Official Title

Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for 30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The ultimate goals of introducing new modality treatments such as monoclonal antibody (Ab)-targeted therapy are to increase complete remission (CR) rate and prolong event-free survival and overall survival.In phase II trials, it was shown that in DLBL the addition of rituximab to CHOP was feasible, with an increase in ORR, including CR and an increase in the OS and PFS in patients with DLBL.2 The benefit of R-CHOP was consistent across all subgroups of patients tested, including good and poor risks according to IPI and independent of younger than 70 years and older than 70 years of age. Recently, new radiolabeled monoclonal antibodies have been established in the therapy of malignant lymphoma which can induce high remission rates. Radiolabeled antibodies are particularly effective as lymphoma cells are highly sensitive to radiation. In addition, the local emission of radiolabeled antibodies is able to destroy cells in close proximity to the bound antibody (bystander effect) therefore circumventing the problem of limited perfusion of bulky or poorly vascularized tumors.Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin). To optimize biodistribution, Rituximab is given prior to the radiolabeled antibody. Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab. ORR in the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group (80% vs. 56% according to International Workshop Response criteria or 73% vs. 47% according to protocol-defined evaluation of response). Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma, it is worthwhile to study the consolidation therapy with Yt90-ibritumomab tiuxetan (Yt90-Zevalin) in patients who achieved at least unconfirmed partial remission after 6 cycles of CHOP therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

Keywords

CHOP-Z

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemotherapy followed by Zevalin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

chemotherapy followed by Zevalin

Intervention Description

Primary Outcome Measure Information:

Title

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

Time Frame

2 year

Secondary Outcome Measure Information:

Title

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

Time Frame

2 year

Title

Determine safety and tolerability of Yt90-Zevalin consolidation therapy.

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Surapol Issaragrisil, M.D.

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital, Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP

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