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Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism


Phase 2
10 Years
55 Years
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism


OBJECTIVES:

- Determine the effect of irradiated donor T-cell infusion on donor T-cell chimerism 6
weeks after hematopoietic stem cell transplantation in patients with hematologic
malignancies.

- Determine the infusional toxic effects of irradiated donor lymphocytes in these
patients.

- Determine the risk of acute and chronic graft-versus-host disease from donor lymphocyte
infusions on day 45 and day 100 posttransplantation in HLA 6/6 matched transplantations
from a related donor in these patients.

- Determine disease-free survival, cytomegalovirus reactivation, and relapse in patients
treated with this regimen.

- Determine transplant-related mortality and death from all causes in patients treated
with this regimen.

OUTLINE:

- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4
and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo total body
irradiation on days -7 to -4.

- Pretransplantation irradiated donor lymphocyte infusion (DLI): Patients receive
irradiated DLI on day -4.

- Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day
0.

- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days
44-120.

- Posttransplantation DLI: Patients receive DLI on days 45 and 100. Patients with chronic
myelogenous leukemia in chronic phase who are polymerase chain reaction negative for
bcr/abl receive DLI on day 45 only.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of any of the following hematologic malignancies:

- Chronic myelogenous leukemia (CML) in chronic phase meeting 1 of the following
criteria:

- Under 41 years of age with no prior imatinib mesylate therapy

- 10 to 55 years of age and failed prior imatinib mesylate therapy

- 41 to 55 years of age for whom imatinib mesylate is not the treatment of
choice

- CML in accelerated phase or blast transformation

- Acute lymphoblastic leukemia meeting any of the following criteria:

- Over 18 years of age and in first remission with high-risk features (e.g.,
WBC greater than 100,000/mm^3, karyotypes t[9;22], t[4], t[19], t[11], and
biphenotypic leukemia)

- Second or subsequent remission

- Primary induction failure

- Partially responding or untreated relapse

- Acute myeloid leukemia meeting any of the following criteria:

- First remission, except with good-risk karyotypes (e.g., M3 t[15;17], M4E0
inv[16], t[8;21])

- Second or subsequent remission

- Primary induction failure

- Resistant relapse

- Myelodysplastic syndromes of any of the following types:

- Refractory anemia (RA) with transfusion dependence

- RA with excess blasts

- In transformation to acute leukemia

- Chronic myelomonocytic leukemia

- Myeloproliferative disorders in transformation to acute leukemia, of any of the
following types:

- Myelofibrosis

- Polycythemia vera

- Essential thrombocythemia

- Chronic lymphocytic leukemia that is refractory to fludarabine with 1 of the
following:

- Bulky progressive disease

- Thrombocytopenia (WBC no greater than 100,000/mm^3)*

- Anemia (hemoglobin no greater than 10 g/dL)* NOTE: *Not due to recent
chemotherapy

- Non-Hodgkin's lymphoma, including mantle cell lymphoma, relapsing or refractory
to current chemotherapy and monoclonal antibody therapy and unsuitable for
autologous stem cell transplantation

- Availability of a HLA-identical (6/6) family donor

PATIENT CHARACTERISTICS:

Age

- 10 to 55

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin no greater than 4 mg/dL

- Transaminases no greater than 3 times upper limit of normal

Renal

- Creatinine no greater than 3 mg/dL

Cardiovascular

- LVEF at least 40% of predicted

Pulmonary

- DLCO at least 60% of predicted

Other

- Not pregnant

- Negative pregnancy test

- HIV negative

- No severe psychiatric illness or mental deficiency that would preclude giving
informed consent or complying with study treatment

- No major illness or organ dysfunction that would preclude transplantation

- No other prior malignancy except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

- No prior continuous busulfan for more than 6 months duration

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Austin J. Barrett, MD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

NHLBI - Bone Marrow Transplantation Unit

Authority:

United States: Federal Government

Study ID:

CDR0000315460

NCT ID:

NCT00066300

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • primary myelofibrosis
  • polycythemia vera
  • essential thrombocythemia
  • adult acute lymphoblastic leukemia in remission
  • recurrent adult acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • recurrent adult acute myeloid leukemia
  • refractory chronic lymphocytic leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • chronic myelomonocytic leukemia
  • refractory anemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • de novo myelodysplastic syndromes
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182