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Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV


Phase 2
N/A
75 Years
Open (Enrolling)
Both
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Nasal Type Extranodal NK/T-cell Lymphoma, AIDS-related Diffuse Large Cell Lymphoma, AIDS-related Diffuse Mixed Cell Lymphoma, AIDS-related Diffuse Small Cleaved Cell Lymphoma, AIDS-related Immunoblastic Large Cell Lymphoma, AIDS-related Lymphoblastic Lymphoma, AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Small Noncleaved Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, de Novo Myelodysplastic Syndromes, HIV-associated Hodgkin Lymphoma, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, 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 Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Secondary Myelodysplastic Syndromes

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Trial Information

Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV


PRIMARY OBJECTIVES:

I. To examine the development of donor-derived HIV-1-specific immune response following
hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+
patients.

II. To examine the affect of HCT on the pool of latently infected cluster of differentiation
(CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

SECONDARY OBJECTIVES:

I. To determine mortality caused by HIV-related events following HCT in HIV+ patients.

II. To determine feasibility of continuous HAART administration after conditioning, defined
by number of days off highly active antiretroviral therapy (HAART).

III. Examine control of HIV-1 replication after HCT, defined by number of days without
evidence of HIV-1 messenger ribonucleic acid (mRNA) (viral load).

OUTLINE:

Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at
days +90, +180, +365, and +730. Patients receive conditioning regimen, undergo either
allogeneic or autologous marrow or peripheral blood stem cell transplantation, and receive
graft-vs-host disease prophylaxis according to standard medical procedures. Patients undergo
blood sample collection periodically for biomarker analysis.


Inclusion Criteria:



- HIV positive

- Treatment with HAART for at least 1 month

- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on
HAART therapy

- Hematologic malignancy associated with a poor prognosis with medical therapy alone -
diagnoses to be included:

- Acute Myeloid Leukemia in first remission, second remission, or relapse

- Acute Lymphoblastic Leukemia in first remission, second remission, or relapse

- Chronic Myeloid Leukemia in accelerated phase or blast phase. Chronic phase is
allowed if patient has not achieved a cytogenetic remission or has developed
unacceptable toxicity to medical therapy, such as tyrosine kinase inhibitor
therapy

- Myelodysplastic syndrome (MDS) with International Prognostic Scoring System
(IPSS) score > 1

- Myeloproliferative disorders, including Chronic Myelomonocytic Leukemia (CMML),
Agnogenic Myeloid Metaplasia with Myelofibrosis, Juvenile CML, or unclassified
myeloproliferative disorders

- Hodgkin Lymphoma beyond first remission; first remission allowed if approved by
Patient Care Conference

- Non-Hodgkin Lymphoma beyond first remission; first remission allowed if approved
by Patient Care Conference

- Approval for allogenic regimen given at Patient Care Conference

- Additional inclusion criteria may apply if the patient is also enrolled on a Primary
Research Protocol; please refer to the Primary Research Protocol for additional
required inclusion criteria; eligibility criteria for patients enrolled at other
institutions may be determined by the Institutional Primary Research protocol in lieu
of criteria listed above

- DONOR: Autologous peripheral blood with CD34+ cell dose of > 3.0 x 10^6 cells per
kilogram recipient weight; autologous recipients are allowed to proceed to
nonmyeloablative allogeneic HCT on protocol 1410

- DONOR: Related donor matched for at least 9 of 10 human leukocyte antigen (HLA)-A, B,
C, DRB1, and DQB1 alleles

- DONOR: Unrelated donor matched for at least 9 of 10 HLA-A, B, C, DRB1, and DQB1
alleles and willing to donate either marrow or peripheral blood stem cells; the
acceptable level of the single mismatch is defined as an allele level mismatch at
HLA-DRB1 or an antigen level mismatch at HLA-A, B, C, or DQB1

- DONOR: Donor inclusion criteria may be expanded in the case where the patient is also
enrolled on a separate Institutional Review Board (IRB)-approved Primary Research
Protocol; please refer to the Primary Research Protocol for Donor Inclusion Criteria

Exclusion Criteria:

- Positive serology for toxoplasma gondii AND requiring treatment or with evidence of
active infection

- A medical history of noncompliance with HAART or medical therapy

- Serum creatinine > 2 times upper limit of normal (ULN)

- Serum bilirubin greater than 3 times the ULN unless determined to be a result of the
primary hematologic malignancy or attributed to Gilbert's Syndrome

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3
times the ULN, unless determined to be a result of the primary hematologic malignancy
or attributed to Gilbert's Syndrome

- Forced vital capacity (FVC), forced expiratory volume (FEV)1 or diffusing capacity of
the lung for carbon monoxide (DLCO) parameters < 60% predicted (corrected for
hemoglobin)

- Cardiac insufficiency or coronary artery disease requiring treatment

- Active infection requiring systemic antibiotic therapy with antibacterial,
antifungal, or antiviral agents (excluding HIV)

- Karnofsky performance score < 70

- Cardiac insufficiency or coronary artery disease requiring treatment

- Active infection requiring systemic antibiotic therapy with antibacterial,
antifungal, or antiviral agents (excluding HIV)

- Karnofsky performance score < 70

- Patients capable of conceiving a child and unwilling to use procedures to prevent
conception

- Pregnancy or patients actively breastfeeding

- Additional exclusion criteria may apply if the patient is also enrolled on a Primary
Research Protocol; please refer to the Primary Research Protocol for additional
exclusion criteria

- DONOR: HIV positive

- DONOR: Medical or psychological reason that would make donor procedure intolerable

- DONOR: Age > 75 years

- DONOR: Medical history, physical exam, or laboratory findings that indicate donation
would entail excess risk to donor or patient; this includes, but is not limited to
pregnancy, history of autoimmune disorder, thromboembolism, serious adverse reaction
to anesthesia, current treatment with lithium or monoclonal antibodies or any
experimental drug, laboratory findings of hemoglobinopathy, thrombocytopenia, or
blood borne pathogens; any unrelated donor must have approval by the Donor Center
after evaluation by history and physical

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quantification of HIV-1-specific immune response

Outcome Description:

Quantitative plasma HIV RNA will be determined by a branched-chain DNA based assay and CD4+ and CD8+ T cell subsets will be evaluated by flow cytometry.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Ann Woolfrey

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

2212.00

NCT ID:

NCT00968630

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Accelerated Phase Chronic Myelogenous Leukemia
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • AIDS-related Diffuse Large Cell Lymphoma
  • AIDS-related Diffuse Mixed Cell Lymphoma
  • AIDS-related Diffuse Small Cleaved Cell Lymphoma
  • AIDS-related Immunoblastic Large Cell Lymphoma
  • AIDS-related Lymphoblastic Lymphoma
  • AIDS-related Peripheral/Systemic Lymphoma
  • AIDS-related Small Noncleaved Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Burkitt Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • de Novo Myelodysplastic Syndromes
  • HIV-associated Hodgkin Lymphoma
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • 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 Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Secondary Myelodysplastic Syndromes
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Blast Crisis
  • Burkitt Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell
  • Leukemia, Myelomonocytic, Juvenile
  • Lymphoma, Extranodal NK-T-Cell
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
City of HopeDuarte, California  91010