Studying T Cells in Patients Undergoing Donor Stem Cell Transplant for Hematologic Cancer or Other Diseases - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00653289

Purpose

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening. Studying samples of blood from patients with cancer or other diseases in the laboratory may help doctors learn more about changes in T cells in patients undergoing donor stem cell transplant.

PURPOSE: This clinical trial is studying T cells in patients undergoing donor stem cell transplant for hematologic cancer or other diseases.

Condition	Intervention
Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Drug: cyclophosphamide Drug: cytarabine Other: laboratory biomarker analysis Procedure: allogeneic hematopoietic stem cell transplantation Radiation: total-body irradiation

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	T-REGULATORY CELL KINETICS POST TRANSPLANT FOR PATIENTS UNDERGOING MATCHED SIBLING STEM CELL TRANSPLANTATION

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Radiation Therapy

Drug Information available for: Cyclophosphamide Cytarabine hydrochloride Cytarabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biologic recovery and behavior of T-regulatory cells in patients undergoing donor stem cell transplantation [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Primary Completion Date:	December 2026 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To define the biologic recovery and behavior of T-regulatory (Treg) cells in patients undergoing donor stem cell transplantation for hematologic cancer or other diseases as a prelude to designing clinical trials in which perturbation of Treg cells is investigated as a means in reducing relapse, graft-versus-host disease, and infection.

OUTLINE: This is a multicenter study.

Conditioning regimen: Patients receive cytarabine IV every 12 hours on days -8 to -5 and cyclophosphamide IV once daily on days -7 to -6. Patients also undergo total body irradiation* twice daily on days -4 to -1 (8 fractions). NOTE: *Patients with testicular or CNS disease or other focal disease may receive additional irradiation.
Donor stem cell transplantation: Patients undergo donor stem cell transplantation on day 0.
Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV beginning on day -2 and continuing according to institutional guidelines. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Blood samples are collected periodically during study to measure changes in the number and function of CD4+CD25+ Foxp3 regulatory T-cells at specific time points after transplantation and to correlate these changes with GVHD.

After completion of study therapy, patients are followed periodically.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
- Acute or chronic leukemia
- Advanced Hodgkin or non-Hodgkin lymphoma
- Myelodysplastic syndromes or myeloproliferative disease
Unlikely to be cured by standard chemotherapy
- Patients who relapsed after standard chemotherapy or those in first remission with unfavorable prognostic features are eligible
Must have a genotypically HLA-identical sibling stem cell donor available

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100%
Life expectancy > 6 weeks (not limited by disease other than leukemia)
No symptomatic cardiac failure unrelieved by medical therapy
No evidence of symptomatic cardiac dysfunction
Shortening fraction ≥ 20% by ECHO
No severe renal disease
Creatinine ≤ 3 times normal for age
No pre-existing severe restrictive pulmonary disease
FVC ≥ 40% of predicted
No severe hepatic disease
Direct bilirubin ≤ 3 mg/dL
AST ≤ 500 IU/L
No severe personality disorder or mental illness
No severe infection that prohibits the use of ablative chemotherapy
HIV negative

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653289

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297
Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Marlen Dinu 832-824-4881
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030-2399
Contact: Marlen Dinu 832-824-4881

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Study Chair:

Robert Krance, MD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000582426, BCM-H-19164
Study First Received:	April 3, 2008
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00653289 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
adult acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia
refractory chronic lymphocytic leukemia

relapsing chronic myelogenous leukemia
childhood chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
juvenile myelomonocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma

Study placed in the following topic categories:

Anti-Infective Agents
Chronic Myelomonocytic Leukemia
Blast Crisis
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Follicular Lymphoma
Mycoses
Acute Myelocytic Leukemia
Preleukemia
Acute Myeloid Leukemia, Adult
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Hodgkin Disease
Myelodysplastic Myeloproliferative Disease
Lymphoma, Large B-Cell, Diffuse

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Hairy Cell Leukemia
Myeloproliferative Disorders
Juvenile Myelomonocytic Leukemia
Leukemia, Myeloid
B-cell Lymphomas
Leukemia, Myeloid, Accelerated Phase
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Antimetabolites

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia
Preleukemia
Pathologic Processes
Therapeutic Uses
Syndrome
Alkylating Agents

Lymphoma
Cytarabine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Disease
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 10, 2009