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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00473551

Purpose

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 at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.

Secondary Objective:

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

Condition	Intervention	Phase
Leukemia Lymphoma Myeloma	Drug: Rituximab Drug: Cyclophosphamide Drug: Fludarabine Drug: Mesna Radiation: Radiation Treatment Procedure: Stem Cell Transplantation	Phase I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

Drug Information available for: Mesna Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find the highest tolerable dose of anti-third party cytolytic lymphocytes (CTLs) that can be given in the treatment of lymphoma, CLL, or multiple myeloma. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the safety and effectiveness of this treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rituximab + Cyclophosphamide + Fludarabine with Stem Cell Transplantation	Drug: Rituximab 375 mg/m^2 IV on Day -13, followed by 1000 mg/m^2 IV Weekly on Days -6, 1, and 8 Drug: Cyclophosphamide 50 mg/kg x 1 Day, immediately following Fludarabine Drug: Fludarabine 40 mg/m^2 IV Daily x 4 Days Drug: Mesna 10 mg/kg IVPB x 4 hours for total of 6 doses following cyclophosphamide Radiation: Radiation Treatment 2Gy Total body radiation day before transplantation Procedure: Stem Cell Transplantation Vein infusion of stem cells Dose level 1: 10e7 CD8+/kg

Arms

Assigned Interventions

1: Experimental

Rituximab + Cyclophosphamide + Fludarabine with Stem Cell Transplantation

Drug: Rituximab

375 mg/m^2 IV on Day -13, followed by 1000 mg/m^2 IV Weekly on Days -6, 1, and 8

Drug: Cyclophosphamide

50 mg/kg x 1 Day, immediately following Fludarabine

Drug: Fludarabine

40 mg/m^2 IV Daily x 4 Days

Drug: Mesna

10 mg/kg IVPB x 4 hours for total of 6 doses following cyclophosphamide

Radiation: Radiation Treatment

2Gy Total body radiation day before transplantation

Procedure: Stem Cell Transplantation

Vein infusion of stem cells Dose level 1: 10e7 CD8+/kg

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70
Confirmed diagnosis of follicular lymphoma, mantle cell lymphoma, chronic lymphocyte leukemia/small lymphocytic lymphoma or multiple myeloma. Patients must have had persistent or progressive disease despite initial chemotherapy. Patients must have achieved a partial or complete response to their most recent chemotherapy.
Patients must have an HLA matched (HLA-A, B, C DR or DQ) related donor who is seropositive against Epstein Barr virus and capable of donating peripheral blood mononuclear cells and peripheral blood progenitor cells.
Patient must be HLA completely mismatched for HLA class I loci (A, B and C) with the 3rd party stimulator cells. HLA-A (330301, 310102) HLA-B (5801,150101[62]) HLA-C (0302, 030301)
Zubrod PS of 0 or 1
Creatinine < 1.8 mg/dl
Ejection fraction >/=40%
Corrected DLCO >/=45% predicted
Serum bilirubin </=1.5 mg/dl if not due to Gilbert's syndrome

Exclusion Criteria:

Uncontrolled infection
HIV, hepatitis B surface antigen or hepatitis C seropositive
SGPT > 200 IU/ml
Pregnant or lactating women i.e., positive Beta HCG test in a woman with child bearing potential. Child bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473551

Contacts

Contact: Richard E. Champlin, MD

713-792-8750

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Richard E. Champlin, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Richard E. Champlin, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Richard E. Champlin, MD/Chair )
Study ID Numbers:	2005-0682
Study First Received:	May 11, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00473551
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Lymphocytic Leukemia
Lymphoma
Myeloma
Leukemia
Anti-Third Party Cytolytic Lymphocytes
Indolent Lymphoid Malignancies
Fludarabine

Rituximab
Rituxan
Cyclophosphamide
Cytoxan®
Neosar®
Stem Cell Transplantation
T-lymphocytes

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Fludarabine monophosphate
Cyclophosphamide
Multiple Myeloma
Leukemia

Lymphatic Diseases
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Lymphoproliferative Disorders
Mesna
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009