Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

Phase 2CompletedNCT00572013

University of Nebraska32 enrolled

Overview

To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy. This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

RituxanDRUG

375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant

BEAMDRUG

BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1

Autologous stem cell transplantPROCEDURE

following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR). o Small lymphocytic, marginal zone, mantle cell, and follicular histologies. * At least 19 years of age * Signed written informed consent * Expected survival of at least 6 months * WHO performance status greater or equal to 2 * Male or female subjects of reproductive potential who are able to follow accepted birth control measures. Exclusion Criteria: * No history of T-cell lymphoma * Not pregnant or lactating women * No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study

Locations (1)

University of Nebraska Medical Center, Section of Oncology/Hematology

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Response rate

Disease response at day 100

Time frame: 100 day

Secondary Outcomes

Overall survival

Survival time from diagnosis until death

Time frame: diagnosis until death

Data from ClinicalTrials.gov

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