Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Lymphoma, B-Cell Clinical Trial

Official title:

Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00577629
• Other study ID #: Pro00007096
• Secondary ID: GSK-1034215762
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: June 20, 2016
• Start date: June 2005
• Est. completion date: February 2021

Study information

• Verified date: June 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Description:

This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: February 2021
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Untreated, biopsy proven B-cell non-Hodgkin's lymphoma

• Age >/= 18 years

• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.

• Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Exclusion Criteria:

• Significant medical and/or psychiatric illness which may compromise planned treatment;

• Pregnant or lactating;

• HIV-infection.

• Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• cyclophosphamide
1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
• etoposide
300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
• rituximab
375mg/m2 each week x 4 weeks of induction, beginning on day 1
• cytarabine
3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
• doxorubicin
45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
• tositumomab
450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 Year Progression-free Survival Rate	Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.	1 year	No
Secondary	Disease-free Survival in Patients With a Complete Response (CR or CRu)	Disease-free survival is measured from the date of CR or CRu to date of relapse or death	10 years	No
Secondary	Overall Survival	Overall Survival is measured from the first day of chemotherapy until death from any cause.	10 years	No
Secondary	Overall Response	Number of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.; CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.; PR =; >/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.; No increase should be observed in the size of other nodes, liver, or spleen.; Splenic and hepatic nodules must regress by = 50% in their SPD or, for single nodules, in the greatest transverse diameter.; Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.; Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.; No new sites of disease should be observed.	up to 1 year	No
Secondary	Secondary Malignancies	The number of patients who develop a secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.	10 years	Yes