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Studying Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
This study is currently recruiting participants.
Verified by Fred Hutchinson Cancer Research Center, December 2009
First Received: August 28, 2009   Last Updated: December 15, 2009   History of Changes
Sponsor: Fred Hutchinson Cancer Research Center
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00968630
  Purpose

Rationale: Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.

Purpose: This phase II trial is studying the immune response after stem cell transplant in HIV-positive patients with hematologic cancer.


Condition Intervention Phase
Hematopoietic/Lymphoid Cancer
Leukemia, Myeloid, Aggressive-Phase
Blastic Phase Chronic Myelogenous Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Adult Acute Lymphoblastic Leukemia in Remission
Recurrent Adult Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Recurrent Childhood Acute Lymphoblastic Leukemia
Adult Acute Myeloid Leukemia in Remission
Recurrent Adult Acute Myeloid Leukemia
Childhood Acute Myeloid Leukemia in Remission
Recurrent Childhood Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Disease, Unclassifiable
Childhood Myelodysplastic Syndromes
De Novo Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
HIV-associated Hodgkin Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Childhood Anaplastic Large Cell Lymphoma
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
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 Peripheral/Systemic Lymphoma
AIDS-related Small Noncleaved Cell Lymphoma
AIDS-related Lymphoblastic Lymphoma
Anaplastic Large-Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Burkitt Lymphoma
HIV Infections
Procedure: leukapheresis
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
Other: DNA analysis
Other: RNA analysis
Other: flow cytometry
Other: reverse transcriptase-polymerase chain reaction
Other: nucleic acid sequencing
Other: protein expression analysis
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Myeloablative Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Quantification of HIV-1-specific immune response [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Quantification of latent HIV reservoir [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-associated mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Feasibility of continuous HAART after conditioning [ Time Frame: Number of days off HAART ] [ Designated as safety issue: Yes ]
  • Feasibility of controlling HIV-1 replication post-HCT [ Time Frame: Number of days without evidence of HIV-1 mRNA (viral load) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, and +365. 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.
Procedure: leukapheresis
Undergo leukapheresis
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo transplantation
Procedure: autologous hematopoietic stem cell transplantation
Undergo transplantation
Procedure: peripheral blood stem cell transplantation
Undergo transplantation
Other: laboratory biomarker analysis
correlative study
Other: DNA analysis
correlative study
Other: RNA analysis
correlative study
Other: flow cytometry
correlative study
Other: reverse transcriptase-polymerase chain reaction
correlative study
Other: nucleic acid sequencing
correlative study
Other: protein expression analysis
correlative study

Detailed Description:

Primary Objectives:

I. Examine the development of donor-derived HIV-1-specific immune response following HCT for treatment of hematologic malignancy in HIV+ patients.

II. Examine the affect of HCT on the pool of latently infected CD4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

Secondary Objectives:

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

II. Determine feasibility of continuous HAART administration after conditioning, defined by number of days off HAART.

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

Outline: Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, and +365. 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.

  Eligibility

Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Diagnoses to be included: 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 IPSS score > 1
  • Diagnoses to be included: myeloproliferative disorders, including chronic myelomonocytic leukemia (CMML), agnogenic myeloid metaplasia with myelofibrosis, juvenile CML, or unclassified myeloproliferative disorders; Hodgkin's lymphoma beyond first remission; non-Hodgkin's lymphoma beyond first remission
  • Approval for regimen given at Patient Care Conference
  • The patient must have autologous or allogeneic donor marrow or peripheral blood stem cells available
  • Related donor matched for at least 9 of 10 HLA-A, B, C, DRB1, and DQB1 alleles
  • Unrelated donor matched for at least 9 of 10 HLA-A, B, C, DRB1, and DQB1 alleles

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
  • Prior myeloablative allogeneic or autologous transplant using any hematopoietic stem cell source
  • Evidence of poor medical health, other than primary disease
  • Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968630

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Intake Office     800-804-8824        
Principal Investigator: Ann E. Woolfrey            
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Ann Woolfrey Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center ( Woolfrey, Ann )
Study ID Numbers: FHCRC-2212.00, NCI-2009-01244
Study First Received: August 28, 2009
Last Updated: December 15, 2009
ClinicalTrials.gov Identifier: NCT00968630     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
treatment experienced

Additional relevant MeSH terms:
Blast Crisis
Slow Virus Diseases
Lymphoma, Mantle-Cell
Neoplasms, Experimental
Preleukemia
Pathologic Processes
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Acquired Immunodeficiency Syndrome
Myeloproliferative Disorders
Leukemia, Myeloid
Herpesviridae Infections
Virus Diseases
Neoplasms
HIV Infections
Leukemia, Myeloid, Accelerated Phase
Leukemia, T-Cell
DNA Virus Infections
Lymphoma, Non-Hodgkin
Cell Transformation, Neoplastic
Lymphoma, T-Cell, Cutaneous
Disease Attributes
Leukemia, Lymphoid
Sexually Transmitted Diseases, Viral

ClinicalTrials.gov processed this record on February 08, 2010