Lymphoma Clinical Trial
Official title:
Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals (BMT CTN #0903)
Verified date | December 2022 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2018 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: 1. HIV-1 infection, as documented by a rapid HIV test or any FDA-Approved HIV-1 Enzyme or Chemiluminescence Immunoassay (E/CIA) test kit and confirmed by Western Blot at any time prior to study entry. HIV antigen, plasma HIV-1 RNA, or a secondary antibody test by a method other than rapid HIV and E/CIA is acceptable as an alternative test. Alternatively, if a rapid HIV test or any FDA-Approved HIV-1 Enzyme or Chemiluminescence Immunoassay (E/CIA) test is not available, two HIV-1 RNA values = 2000 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent, may be used to document infection. 2. Patients must be willing to comply with effective Antiretroviral Therapy. 3. Patients must be = 15 years of age. 4. Hematological malignancy associated with a poor prognosis with medical therapy alone. Diagnoses to be included: 1. Patients with the diagnosis of Acute Myeloid or Lymphocytic Leukemia (AML or ALL) in first or second complete remission. 2. Patients with advanced myelodysplastic syndromes (MDS), including those with International Prognostic Scoring System (IPSS) Int-2 and high-risk disease with less than 10% marrow blasts and no circulating myeloblasts after most recent therapy. Patients with acute leukemia that develops from a pre-existing MDS must meet the inclusion criteria for patients with AML detailed above. 3. Hodgkin Lymphoma beyond first remission achieving at least a partial response to most recent therapy with no evidence of progression prior to transplant. 4. Non-Hodgkin Lymphoma beyond first remission achieving at least a partial response to most recent therapy with no evidence of progression prior to transplant. 5. Donor/Recipient HLA Matching: 1. Related donor: must be an 8/8 match at HLA-A, -B, -C, (serologic typing or higher resolution) and -DRB1 (at high resolution using DNA based typing). A 7/8 related donor match is permitted only if an 8/8 unrelated donor cannot be identified. 2. Unrelated donor: must be a 7/8 or 8/8 match at HLA-A, -B, -C, and -DRB1 (at high resolution using DNA based typing). 6. Patients with adequate organ function as measured by: 1. Cardiac: Left ventricular ejection fraction at rest = 40% demonstrated by Multi Gated Acquisition Scan (MUGA) or echocardiogram. Patients with known heart disease must have a functional status no worse than American Heart Association Class I defined as patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. 2. Hepatic: i. Total Bilirubin < 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome or antiretroviral therapy as specified in Appendix E) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5x the upper limit of normal. ii. Concomitant Hepatitis: Patients with chronic hepatitis B or C may be enrolled on the trial providing the above bilirubin and transaminase criteria are met. In addition, there must be no clinical or pathologic evidence of irreversible chronic liver disease, and there must be no active viral replication as evidenced by an undetectable hepatitis viral load by a PCR-based assay. c) Renal: Creatinine clearance (calculated creatinine clearance is permitted) > 40 mL/min. d) Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) = 45% of predicted (corrected for hemoglobin). 7. Signed Informed Consent Exclusion Criteria: 1. Karnofsky/Lansky performance score < 70%. 2. Active central nervous system (CNS) malignancy; however, patients with a history of positive Cerebrospinal fluid (CSF) cytology that has become negative with intrathecal chemotherapy are eligible. 3. Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement). 4. Active Cytomegalovirus (CMV) retinitis or other CMV-related organ dysfunction. 5. AIDS related syndromes or symptoms that pose a perceived excessive risk for transplantation-related morbidity as determined by the principal investigator. 6. Untreatable HIV infection due to multidrug antiretroviral resistance. Patients with a detectable viral load > 750 copies/ml should be evaluated with an HIV drug resistance test (HIV-1 genotype). The results should be included as part of the Antiretroviral Review (described in Appendix D). This Review Committee will make the final determination as to whether HIV viremia could potentially be suppressed with alternate antiretroviral therapy. . 7. Pregnant (positive ß-HCG) or breastfeeding. 8. Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant. 9. Prior allogeneic HCT. 10. Patients with psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator. 11. T-cell depletion (including ATG or alemtuzumab) is not allowed. 12. Use of cord blood as the source of hematopoietic cells is not allowed. |
Country | Name | City | State |
---|---|---|---|
United States | Blood & Marrow Transplant Program at Northside Hospital | Atlanta | Georgia |
United States | Johns Hopkins | Baltimore | Maryland |
United States | City of Hope National Medical Center | Duarte | California |
United States | University of Texas/MD Anderson CRC | Houston | Texas |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Mayo Clinic - Phoenix | Phoenix | Arizona |
United States | Mayo Clinic - Rochester | Rochester | Minnesota |
United States | Texas Transplant Institute | San Antonio | Texas |
United States | University of CA, SF | San Francisco | California |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program |
United States,
Scott BL, Pasquini MC, Logan BR, Wu J, Devine SM, Porter DL, Maziarz RT, Warlick ED, Fernandez HF, Alyea EP, Hamadani M, Bashey A, Giralt S, Geller NL, Leifer E, Le-Rademacher J, Mendizabal AM, Horowitz MM, Deeg HJ, Horwitz ME. Myeloablative Versus Reduce — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Non-Relapse Mortality | The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy. | Day 100, 1 Year, and 2 Years Post-transplant | |
Secondary | Percentage of Participants With Overall Survival | Overall survival is defined as the time from transplant to death from any cause. | Six months, 1 Year, and 2 Years Post-transplant | |
Secondary | Percentage of Participants With Relapse/Progression | Relapse/Progression is defined as relapse or progression of the primary malignancy. | 1 Year Post-transplant | |
Secondary | Primary Cause of Death | Up to 2 Years Post-transplant | ||
Secondary | Disease Status | Patients will be assessed for disease status at Day 100 post-HCT, classified as complete remission, partial remission, stable disease, and relapse/progressive disease. | Day 100 Post-transplant | |
Secondary | Percentage of Participants Recovering Hematologic Function | Recovery of hematologic function is described by the time to neutrophil and platelet recovery. Time to neutrophil recovery will be the first of three consecutive days of > 500 neutrophils/µL following the expected nadir. Time to platelet engraftment will be described by the date when platelet count is > 20,000/µL for the first of three consecutive labs with no platelet transfusions 7 days prior. | Days 28 and 100 Post-transplant | |
Secondary | Chimerism | Donor T-cell and myeloid chimerism will be described separately by conditioning regimen intensity (myeloablative or reduced intensity) according to proportions with mixed chimerism (5-95% donor cells out of all), full chimerism (>95% donor cells), or graft rejection (<5% donor cells). | Week 4, Day 100, and 6 months Post-transplant | |
Secondary | Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD) | Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995: Skin stage: 0: No rash Rash <25% of body surface area Rash on 25-50% of body surface area Rash on > 50% of body surface area Generalized erythroderma with bullous formation Liver stage (based on bilirubin level)*: 0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL GI stage*: 0: No diarrhea or diarrhea <500 mL/day Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD Diarrhea 1000-1499 mL/day Diarrhea >1500 mL/day Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1. GVHD grade: 0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4 |
Day 100 Post-transplant | |
Secondary | Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD) | Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. | 1 Year Post-transplant | |
Secondary | Infection Severity | The maximum grade of infections reported by participants are described, as defined in the BMT CTN Technical MOP. | 1 Year Post-transplant |
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