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Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer

Complete title: Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution after Myeloablative Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected with HIV

Research Study Number       2212.00
    
Principal Investigator       Ann Woolfrey, MD
    
Phase       II

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Research Study Description

This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer. 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: up to 75 Years

Genders Eligible for Study: Both

- Age < 66 years for autologous recipients; ages < 76 for allogeneic recipients

- 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 chronic myeloid leukemia (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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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 upper limits of normal, 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 upper limits of normal, unless determined to be a result of the primary hematologic malignancy or attributed to Gilbert's syndrome

- Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) 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; exclusion criteria for patients enrolled at other institutions may be determined by the Institutional Primary Research protocol in lieu of that listed above

- 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

Other exclusion criteria may apply.



Research Study Number       2212.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Hematologic Malignancies; Immunodeficiency Syndromes

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