Expired Study
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Ann Arbor, Michigan 48109


Purpose:

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of immunotherapy).


Study summary:

Combination chemotherapy is the standard treatment as initial therapy for aggressive NHL. Standard chemotherapy cures less than 40% of patients. High-dose chemotherapy with stem cell support (or transplant) is showing some positive results in patients with NHL that fail standard chemotherapy. The cure rate of this treatment is only about 50%. Another treatment option called immunotherapy is being tested in lymphoma patients to see if adding immunotherapy to NHL treatments improves results. Rituximab, a form of immunotherapy, is an antibody (a type of protein) that attacks the CD20 protein found on lymphoma cell, which may result in the death of the lymphoma cell. The study design is as follows: Patients with poor prognosis NHL receive rituximab as part of the peripheral blood progenitor cell mobilization process and as part of the preparative regimen in combination with high-dose chemotherapy. Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood progenitor cells (PBPC) are collected and stored. After recovery from high-dose cyclophosphamide, patients are admitted to the hospital for transplant. The preparative regimen consists of rituximab, followed by high-dose chemotherapy.


Criteria:

Inclusion Criteria: - Histologically documented, aggressive and/or intermediate grade and high-grade B cell NHL, CD20 positive. - Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas. - NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score. - Complete or partial response to first-line therapy. - Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry. - Cumulative total doxorubicin: <500 mg/m2 - Performance score 0-2 - Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease. - Patients must not be pregnant or nursing. - Informed Consent Exclusion Criteria: - pregnant or nursing


Study is Available At:


Original ID:

UMCC 2-51


NCT ID:

NCT00141700


Secondary ID:


Study Acronym:


Brief Title:

Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma


Official Title:

Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Poor-Prognosis Non-Hodgkin's Lymphoma


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

enrollment completed


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Overall Contact Information

Official Name:Raymond J. Hutchinson, MD
Principal Investigator
The University of Michigan

Study Dates

Start Date:March 2003
Completion Date:December 2005
Completion Type:Actual
Primary Completion Date:March 2005
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 28, 2007
First Received Date:August 30, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assess overall survival (OS) after rituximab and high-dose chemotherapy with PBPC support.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assess safety and toxicity after rituximab and high-dose chemotherapy.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assess CD20 recovery post-transplant
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Rituximab

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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