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| 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 |
| 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.
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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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Ann Woolfrey | Fred Hutchinson Cancer Research Center |
More Information
| 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 |
|
treatment experienced |
|
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 |