T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE

NCT00578461 | Terminated Results DMC

• 1 other identifier: H-19164 REGKINE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Patients are being asked to participate in this study because they have a cancer in their blood (such as leukemia or lymphoma) or myelodysplastic/myeloproliferative (pre-leukemia). We suggest a treatment that might help them live longer without disease than other treatment plans would. This treatment is known as a stem cell transplant. We believe this may help the patient as it allows us to give much stronger doses of drugs and radiation to kill the diseased cells than we could give without the transplant. We also think that the healthy cells may help fight any diseased cells left after the transplant. Stem Cells are special "mother" cells that are found in the bone marrow (the spongy tissue inside bones), although some are also found in the bloodstream (peripheral blood). As they grow, they become either white blood cells which fight infection, red blood cells which carry oxygen and remove waste products from the organs and tissues or platelets, which enable the blood to clot. For the transplant to take place, we will collect these stem cells from a "donor" (a person who agrees to donate these cells) and give them to the patient. The patient has a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and they will receive a stem cell transplant (SCT). If they have a brother or sister that is a perfect match and agrees to donate, the stem cells will come from him/her. Before the transplant, two very strong drugs plus total body irradiation will be given to the patient (pre-conditioning). This treatment will kill most of the blood-forming cells in the bone marrow. We will then give the patient the healthy stem cells. Once these healthy stem cells are in the bloodstream they will move to the bone marrow (graft) and begin producing blood cells that will eventually mature into healthy red blood cells, white blood cells and platelets. Also, we will ask permission to draw blood from the patient so that we can measure the number of certain blood cells called T regulatory cells. T regulatory cells are special immune cells that can control or regulate the body's immune response. We want to determine whether T regulatory cells are important participants in graft versus host disease (GVHD), infection and relapse. In GVHD, certain cells from the donated marrow or blood (the graft) attack the body of the transplant patient (the host). GVHD can affect many different parts of the body. The skin, eyes, stomach and intestines are affected most often. GVHD can range from mild to life-threatening. We do not know whether T regulatory cells can modify these conditions. We want to measure these T regulatory cells and learn if these cells do influence these conditions. If we learn that T regulatory cells do affect these conditions, then it may be possible to modify these cells for the benefit of transplant patients.

Conditions

Leukemia; Cancer; Lymphoma; Lymphoma, Hodgkin; Lymphoma, Non-Hodgkin

Keywords

Stem Cell Transplant; myeloproliferative disease; myelodsyplastic disease; Leukemia; Cancer; Lymphoma; Lymphoma, Hodgkin; Lymphoma, non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Median Percentage of Treg Cells at 1 Year Post Transplant

  The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.

  1 Year

Study Arms (1)

Stem Cell Transplant

EXPERIMENTAL

patient's will be recieving a stem cell transplant on study Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation

Drug: Ara C; Drug: Mesna; Drug: Cyclophosphamide; Radiation: TBI-Total Body Irradiation

Interventions

Ara C DRUG

3000 mg/m\^2 - pts will recieve via IV every 12 hours for 6 doses starting at 20:00 hours on day -8

Also known as: Cytarabine, Cytosar-U

Stem Cell Transplant

Mesna DRUG

45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide

Also known as: Mesnex

Stem Cell Transplant

Cyclophosphamide DRUG

45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours

Also known as: Cytoxan

Stem Cell Transplant

TBI-Total Body Irradiation RADIATION

Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4

Stem Cell Transplant

Eligibility Criteria

• Age: Up to 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with acute or chronic leukemia or advanced Hodgkin or non Hodgkin lymphoma or myelodysplastic/myeloproliferative disease who are unlikely to be cured by standard chemotherapy treatments. This includes patients who have relapsed after standard chemotherapy treatments and patients in first remission with unfavorable prognostic features.
• Patient must have a genotype HLA identical stem cell donor.

You may not qualify if:

• Patients with a life expectancy (less than or equal to 6 weeks) limited by disease other than leukemia.
• Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction \<20%).
• Patients with severe renal disease (i.e., creatinine greater than 3 times normal for age).
• Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted).
• Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L).
• Patients with severe personality disorder or mental illness.
• Patients with severe infection that in the estimation of the principal investigator prohibits the use of ablative chemotherapy.
• Patients who are documented HIV positive.
• Patients with a Karnofsky performance score \<60% or Lansky performance score \<50%.
• NOTE: Patients who would be excluded from treatment on this protocol strictly for laboratory or performance abnormalities can be included at the principal investigator's discretion after consultation with the members of the SCT Policy and Procedures Committee.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia; Neoplasms; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Myeloproliferative Disorders

Interventions

Cytarabine; Mesna; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Robert Krance, MD
• Organization: Baylor College of Medicine

rakrance@txch.org

832-824-4661

Study Officials

• Robert Krance, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 22, 2016
• Results First Posted: September 8, 2014

Record last verified: 2016-03

Locations

US (1)