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