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
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
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 Hospital | Houston, Texas 77030-2399 |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston, Texas 77030 |
