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Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies

NCT00473551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2011-12-19

No results posted yet for this study

Summary

Primary Objective:

1\. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.

Secondary Objective:

1\. Toxicity, response rate, time to progression and overall survival.

Conditions

Interventions

DRUG

Rituximab

375 mg/m\^2 intravenously over several hours on Day -13, followed by 1000 mg/m\^2 intravenously on Days -6, 1, and 8.

DRUG

Cyclophosphamide

50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine.

DRUG

Fludarabine

40 mg/m\^2 intravenously over 30 minutes once per day for 4 days, starting Day -6.

DRUG

Mesna

10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide.

RADIATION

Radiation Treatment

2Gy Total body radiation day before transplantation

PROCEDURE

Stem Cell Transplantation (SCT)

Allo CD34+ Selected SCT/Infusion of stem cells.

DRUG

Sirolimus

6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7.

PROCEDURE

Anti-third Party Cytolytic T-lymphocytes (CTL)

Intravenous infusion of anti-third party CTL.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard E. Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473551 on ClinicalTrials.gov