Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01199562
• Date of registration: 08/09/2010
• Prospective Registration: Yes
• Primary sponsor: City of Hope Medical Center
• Public title: Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
• Scientific title: Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function
• Date of first enrolment: December 2010
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01199562
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Ryotaro Nakamura
• Affiliation: City of Hope Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis: hematologic malignancies/disorders including aplastic anemia and
myelodysplastic syndrome

- Procedure: first allogeneic, T cell-replete transplantation of stem-cells from
peripheral blood or bone marrow of an human leukocyte antigen (HLA) matched, unrelated
or nonsyngeneic sibling donor

- CMV seropositive donor and/or recipient

- Performance level: must have already been determined to be eligible for HCT at City of
Hope (COH)

- Organ function requirements: The minimum organ function requirements should be the
same as the requirements for HCT

- Informed Consent: All patients must be capable of signing a written informed consent
and no consent can be provided by a legal guardian

Exclusion Criteria:

- The recipient had prior polymerase chain reaction (PCR) positive CMV infection in
blood or organ-specific disease in the past 12 months

- The source of hematopoietic stem cells is T-cell depleted

- Concomitant anti-graft-versus-host disease (GVD) treatment includes in vivo T cell
depletion

- Recipient is human immunodeficiency virus (HIV)-1 positive

- No prior allogeneic HCT (Allo HCT) (autologous HCT [Auto HCT] is allowed)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Contiguous Stage II Adult Diffuse Large Cell Lymphoma

Cytomegalovirus Infection

Meningeal Chronic Myelogenous Leukemia

Previously Treated Myelodysplastic Syndromes

Recurrent Adult Hodgkin Lymphoma

Recurrent Adult Immunoblastic Large Cell Lymphoma

Recurrent Adult T-cell Leukemia/Lymphoma

Recurrent Grade 2 Follicular Lymphoma

Recurrent Marginal Zone Lymphoma

Stage 0 Chronic Lymphocytic Leukemia

Stage I Adult Immunoblastic Large Cell Lymphoma

Stage I Grade 1 Follicular Lymphoma

Stage I Grade 2 Follicular Lymphoma

Stage III Mantle Cell Lymphoma

Stage IV Adult Immunoblastic Large Cell Lymphoma

Adult Acute Myeloid Leukemia in Remission

Angioimmunoblastic T-cell Lymphoma

Adult Grade III Lymphomatoid Granulomatosis

Contiguous Stage II Adult Burkitt Lymphoma

Chronic Phase Chronic Myelogenous Leukemia

Contiguous Stage II Grade 3 Follicular Lymphoma

Accelerated Phase Chronic Myelogenous Leukemia

Acute Undifferentiated Leukemia

Contiguous Stage II Mantle Cell Lymphoma

Cutaneous B-cell Non-Hodgkin Lymphoma

Stage IV Mantle Cell Lymphoma

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Adult Acute Myeloid Leukemia With Del(5q)

Chronic Myelomonocytic Leukemia

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Chronic Neutrophilic Leukemia

Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma

Atypical Chronic Myeloid Leukemia, BCR-ABL Negative

Blastic Phase Chronic Myelogenous Leukemia

Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma

Contiguous Stage II Adult Lymphoblastic Lymphoma

Chronic Eosinophilic Leukemia

Mast Cell Leukemia

Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma

Noncontiguous Stage II Grade 2 Follicular Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Adult Diffuse Mixed Cell Lymphoma

Noncontiguous Stage II Grade 3 Follicular Lymphoma

Polycythemia Vera

Recurrent Grade 3 Follicular Lymphoma

Stage I Cutaneous T-cell Non-Hodgkin Lymphoma

Contiguous Stage II Small Lymphocytic Lymphoma

Hematopoietic/Lymphoid Cancer

Anaplastic Large Cell Lymphoma

Aplastic Anemia

Contiguous Stage II Marginal Zone Lymphoma

Essential Thrombocythemia

Stage II Adult T-cell Leukemia/Lymphoma

Stage III Adult Diffuse Small Cleaved Cell Lymphoma

Intraocular Lymphoma

Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable

Noncontiguous Stage II Grade 1 Follicular Lymphoma

Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma

Extramedullary Plasmacytoma

Contiguous Stage II Grade 1 Follicular Lymphoma

Nodal Marginal Zone B-cell Lymphoma

Recurrent Grade 1 Follicular Lymphoma

Refractory Multiple Myeloma

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Isolated Plasmacytoma of Bone

Noncontiguous Stage II Adult Lymphoblastic Lymphoma

Noncontiguous Stage II Small Lymphocytic Lymphoma

Splenic Marginal Zone Lymphoma

Stage I Adult T-cell Leukemia/Lymphoma

Noncontiguous Stage II Marginal Zone Lymphoma

Recurrent Adult Acute Myeloid Leukemia

Noncontiguous Stage II Adult Burkitt Lymphoma

Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma

Stage I Multiple Myeloma

Stage II Adult Hodgkin Lymphoma

Recurrent Adult Grade III Lymphomatoid Granulomatosis

Secondary Myelodysplastic Syndromes

Primary Myelofibrosis

Recurrent Adult Diffuse Small Cleaved Cell Lymphoma

Stage III Adult Lymphoblastic Lymphoma

Stage III Grade 1 Follicular Lymphoma

Refractory Chronic Lymphocytic Leukemia

Refractory Hairy Cell Leukemia

Stage I Adult Burkitt Lymphoma

Stage I Adult Diffuse Large Cell Lymphoma

Stage I Mantle Cell Lymphoma

Stage III Chronic Lymphocytic Leukemia

Stage IV Adult Diffuse Mixed Cell Lymphoma

Stage III Adult Hodgkin Lymphoma

Stage III Grade 2 Follicular Lymphoma

Stage I Adult Diffuse Mixed Cell Lymphoma

Stage I Adult Diffuse Small Cleaved Cell Lymphoma

Recurrent Mantle Cell Lymphoma

Recurrent Mycosis Fungoides/Sezary Syndrome

Stage I Chronic Lymphocytic Leukemia

Stage I Mycosis Fungoides/Sezary Syndrome

Relapsing Chronic Myelogenous Leukemia

Stage I Grade 3 Follicular Lymphoma

Stage III Grade 3 Follicular Lymphoma

Stage III Marginal Zone Lymphoma

Stage III Adult Burkitt Lymphoma

Stage III Cutaneous T-cell Non-Hodgkin Lymphoma

Noncontiguous Stage II Mantle Cell Lymphoma

Post-transplant Lymphoproliferative Disorder

Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

Stage II Multiple Myeloma

Stage IV Adult Lymphoblastic Lymphoma

Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma

Stage III Small Lymphocytic Lymphoma

Stage IV Grade 1 Follicular Lymphoma

Progressive Hairy Cell Leukemia, Initial Treatment

Prolymphocytic Leukemia

T-cell Large Granular Lymphocyte Leukemia

Stage IV Grade 2 Follicular Lymphoma

Stage IV Mycosis Fungoides/Sezary Syndrome

Stage II Mycosis Fungoides/Sezary Syndrome

Stage III Mycosis Fungoides/Sezary Syndrome

Recurrent Adult Diffuse Large Cell Lymphoma

Secondary Acute Myeloid Leukemia

Secondary Myelofibrosis

Stage I Adult Lymphoblastic Lymphoma

Stage I Marginal Zone Lymphoma

Stage I Small Lymphocytic Lymphoma

Stage II Chronic Lymphocytic Leukemia

Stage III Adult Immunoblastic Large Cell Lymphoma

Stage III Adult T-cell Leukemia/Lymphoma

Stage IV Adult Diffuse Large Cell Lymphoma

Stage IV Adult Hodgkin Lymphoma

Stage IV Grade 3 Follicular Lymphoma

Waldenstrom Macroglobulinemia

Stage IV Marginal Zone Lymphoma

Adult Acute Lymphoblastic Leukemia in Remission

Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Contiguous Stage II Grade 2 Follicular Lymphoma

de Novo Myelodysplastic Syndromes

Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma

Primary Systemic Amyloidosis

Recurrent Adult Burkitt Lymphoma

Recurrent Adult Lymphoblastic Lymphoma

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Recurrent Small Lymphocytic Lymphoma

Stage I Adult Hodgkin Lymphoma

Stage III Adult Diffuse Large Cell Lymphoma

Stage III Adult Diffuse Mixed Cell Lymphoma

Stage III Multiple Myeloma

Stage IV Adult Burkitt Lymphoma

Stage IV Adult Diffuse Small Cleaved Cell Lymphoma

Stage IV Adult T-cell Leukemia/Lymphoma

Stage IV Chronic Lymphocytic Leukemia

Stage IV Small Lymphocytic Lymphoma

Intervention(s)

Other: laboratory biomarker analysis

Genetic: polymerase chain reaction

Procedure: infection prophylaxis and management

Other: flow cytometry

Drug: ganciclovir

Drug: valganciclovir

Genetic: protein expression analysis

Procedure: antiviral therapy

Drug: foscarnet sodium

Procedure: management of therapy complications

Genetic: DNA analysis

Genetic: RNA analysis

Primary Outcome(s)

Diagnosis of CMV pneumonia [Time Frame: 1 year]

Initiation of anti-CMV therapy [Time Frame: Day 80 post stem cell transplant]

Secondary Outcome(s)

Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells [Time Frame: Day 120 post stem cell transplant]

CMV reactivation-free survival, monitored using a real time PCR assay for CMV DNA in plasma [Time Frame: Up to day 100 post-transplant]

Secondary ID(s)

09038

NCI-2010-01932

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)