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T-Regulatory Cell Kinetics for Patients Receiving Alemtuzumab and Undergoing Stem Cell Transplantation From HLA Mismatched-related or HLA Matched- or Mismatched- Unrelated Donors


N/A
N/A
N/A
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

T-Regulatory Cell Kinetics for Patients Receiving Alemtuzumab and Undergoing Stem Cell Transplantation From HLA Mismatched-related or HLA Matched- or Mismatched- Unrelated Donors


OBJECTIVES:

Primary

- To define the biologic recovery and behavior of T-regulatory cells in patients
undergoing stem cell transplantation.

- To determine if the administration of alemtuzumab as part of conditioning therapy to
patients undergoing stem cell transplantation from mismatched-related donors or from
matched-unrelated donors permits T-regulatory cell recovery.

OUTLINE: This is a multicenter study.

- Stem cell transplantation conditioning regimen: Patients receive cytarabine IV every 12
hours for 6 doses starting on day -8*, cyclophosphamide IV once daily on days -7 and
-6, alemtuzumab IV on days -4 to -1, and undergo total body irradiation (TBI) twice
daily on days -4 to -1 (total of 8 fractions). Patients with CNS disease will receive
additional irradiation to the craniospinal axis.

NOTE: *Patients with T-cell lymphoma do not receive cytarabine.

- Stem cell transplantation: Patients undergo stem cell transplantation on day 0.

- Graft-versus-host-disease (GVHD) prevention: Patients receive tacrolimus IV beginning
on day -2, and continuing according to institutional guidelines, followed by a taper.
Patients also receive methotrexate IV on days +1, +3, +6, and +11.

Blood or bone marrow samples will be collected periodically for regulatory T-cell assay.

After completion of study treatment, patients are followed once a month for 6 months, at 9
months, and at 1, 2, and 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Acute or chronic leukemia

- Advanced Hodgkin or non-Hodgkin lymphoma

- Myelodysplastic/myeloproliferative disease

- Unlikely to be cured by standard chemotherapy treatments

- Relapsed after standard chemotherapy treatments

- In first remission with unfavorable prognostic features

- Must have either a one HLA antigen mismatched-related donor or an HLA
matched-unrelated donor using the standard 6 HLA antigen profile (HLA class I, A and
B, and HLA class II, DRB1)

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 70-100% or Lansky PS 50-100%

- Life expectancy > 6 weeks unless limited by leukemia

- No evidence of symptomatic cardiac dysfunction by echocardiogram (i.e., shortening
fraction < 20%)

- Creatinine ≤ 3 times normal for age

- FVC ≥ 40% of predicted

- Direct bilirubin ≤ 3 mg/dL

- AST ≤ 500 IU/L

- No severe personality disorder or mental illness

- No severe infection that, in the estimation of the principal investigator, prohibits
the use of ablative chemotherapy

- No documented HIV positivity

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biologic recovery and behavior of T-regulatory cells in patients undergoing stem cell transplantation

Safety Issue:

No

Principal Investigator

Robert Krance, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine

Authority:

Unspecified

Study ID:

CDR0000582335

NCT ID:

NCT00647010

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • meningeal chronic myelogenous leukemia
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • splenic marginal zone lymphoma
  • recurrent childhood anaplastic large cell lymphoma
  • stage III childhood anaplastic large cell lymphoma
  • stage IV childhood anaplastic large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • childhood nasal type extranodal NK/T-cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • accelerated phase chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • blastic phase chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • juvenile myelomonocytic leukemia
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • childhood myelodysplastic syndromes
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • de novo myelodysplastic syndromes
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • 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)
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Texas Children's Cancer Center and Hematology Service at Texas Children's HospitalHouston, Texas  77030-2399
Dan L. Duncan Cancer Center at Baylor College of MedicineHouston, Texas  77030