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Allogeneic Donor Leukocyte Infusion | |
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Description: |
Donor leukocyte infusion (donor lymphocyte or buffy coat transfusion) attempts to induce a beneficial graft-versus-tumor response without the need for additional bone marrow harvest from the donor, or further high-dose chemotherapy for the recipient for patients with certain hematologic malignancies who have relapsed after an allogeneic peripheral blood stem cell or bone marrow transplant. Leukocytes are obtained from the original donor in a leukapheresis procedure and are infused into the recipient immediately or after frozen storage.
Donor leukocyte infusion has been studied primarily in patients with chronic myelogenous leukemia who relapse after allogeneic stem cell or bone marrow transplant. When compared to a second allogeneic transplant patients who received donor leukocyte infusion had similar rates of remission, longer survival and less treatment-related mortality. Results from CML may be extrapolated to patients with relapsed acute myelogenous leukemia since there is evidence of graft-versus-leukemia effect in AML patients treated with allogeneic transplants. There are less data regarding other hematologic malignancies.
There is also research interest in the genetic modification of donor leukocytes. Donor leukocytes can be modified by insertion a thymidine kinase gene, rendering the cells susceptible to ganciclovir therapy. If the donor leukocyte infusion results in severe graft-versus-host disease, patients can be treated with ganciclovir to selectively destroy the donor leukocytes. There are inadequate data to permit conclusions regarding the use of genetic modification of donor leukocytes as an adjunct to donor leukocyte infusion.
This policy only addresses the use of donor leukocyte infusion in patients who have relapsed after a prior allogeneic stem cell transplant. Donor leukocyte infusions may also be a component of a nonmyeloablative allogeneic stem cell transplant (mini-transplant), see Coverage Policy # 2000031. In the nonmyeloablative therapy setting, donor leukocyte infusion may be considered as part of the primary treatment.
Regulatory Status
The U.S. Food and Drug Administration regulates certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) under the legal authority of section 361 of the Public Health Service Act (PHS Act) (42 USC 264). This section authorizes the Surgeon General, with the approval of the Secretary of the U.S. Department of Health and Human Services, to make and enforce such regulations as judged necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States or from state to state. According to Addendum 7342.007—Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps), umbilical cord blood stem cells, peripheral blood stem cells, leukocytes (donor leukocytes for infusion, and T cells) are identified by product code 57M.P.
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Policy/ Coverage: |
Effective May 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Donor leukocyte infusion meets member benefit certificate primary coverage criteria and is covered following allogeneic hematopoietic stem cell transplantation (HSCT) that was originally considered medically necessary for the treatment of a hematologic malignancy that has relapsed or is refractory, to prevent relapse in the setting of a high risk of relapse, or to convert a patient from mixed to full donor chimerism.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Donor leukocyte infusion as a treatment of nonhematologic malignancies following a prior allogeneic HSCT does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, donor leukocyte infusion is considered investigational as a treatment of nonhematologic malignancies following a prior allogeneic HSCT. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Genetic modification of donor leukocytes does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, genetic modification of donor leukocytes is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to May 2015
Donor leukocyte infusion meets primary coverage criteria for effectiveness and is covered for patients with most hematologic malignancies who relapse after a prior covered marrow-ablative allogeneic stem cell transplant.
For member contracts or plans with Primary Coverage Criteria, donor leukocyte transfusion as a treatment of other malignancies that relapse after prior marrow-ablative allogeneic stem cell transplant and genetic modification of donor leukocytes is not covered because it fails to meet the Primary Coverage Criteria ("The Criteria") of the applicable benefit certificate or health plan. The Criteria require, among other things, that there be scientific evidence of effectiveness, as defined in The Criteria. The Criteria exclude coverage of treatments if there is lack of scientific evidence regarding the intervention, or, if the available scientific evidence is in conflict or the subject of continuing debate.
For member benefit contracts or Plans with explicit exclusion language for experimental or investigational services, donor leukocyte transfusion as a treatment of other malignancies that relapse after prior marrow-ablative allogeneic stem cell transplant and genetic modification of donor leukocytes are not covered because they are considered experimental or investigational, as defined in the applicable benefit contract or health plan which excludes coverage of experimental or investigational treatment or services.
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Rationale: |
This policy was originally developed in 2002 and has been updated regularly with searches using the MEDLINE database. The following is a summary of the key identified literature.
Several review articles summarize studies that have reported the use of donor lymphocyte infusion (DLI) for the treatment of patients with hematologic malignancies that relapse following allogeneic hematopoietic stem cell transplantation (HSCT) (Deol, 2010; Tombllyn, 2008).
Chronic Myelogenous Leukemia
DLI has been found to be most effective in chronic myelogenous leukemia (CML), inducing a molecular complete remission (CR) in up to 80% of patients who relapse in chronic phase. Only a 12% to 33% response rate has been reported in patients in accelerated or blast phase. Response duration to DLI in patients with relapsed CML after HSCT is long-standing in most patients.
Several large series report outcomes of patients with relapsed CML after receiving DLI (van den Brink, 2010; Simula, 2007; Dazzi, 2000; Guglielmi, 2002; Fozza, 2007; Radujkovic). These studies comprise more than 1000 patients, approximately half of whom had only molecular or cytogenetic relapse at the time of DLI (Deol, 2010). The cell doses varied among patients, with some patients receiving multiple DLI infusions and others, planned dose escalations. Despite these variations, a molecular or cytogenetic CR was achieved in 74% of patients (746/1007). Overall survival (OS) at 3 or more years ranged from 53% to 95%2 and was 64% at 5 years and 59% at 10 years after DLI in another series (Radujkovic, 2015).
The role of DLI in CML has recently changed as the use of tyrosine kinase inhibitors (TKI) has revolutionized the treatment of CML by keeping the disease under control instead of proceeding to HSCT. However, for patients who develop resistance to tyrosine kinase inhibitors or are unable to tolerate the adverse effects, HSCT and DLI may be an option to manage the disease.
Acute Leukemias, Myelodysplasia, and Other Myeloproliferative Diseases
In a 2013 systematic review, El-Jurdi et al evaluated 39 prospective and retrospective studies on DLI for relapse after HSCT for lymphoid malignancies including acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, non-Hodgkin lymphoma (NHL), and Hodgkin lymphoma (HL) (El-Jurdi, 2013). No randomized controlled studies were identified. The studies were heterogeneous thus limiting interpretation of the review. Reported pooled proportions of CR (95% confidence interval [CI]) were 27% (16% to 40%) for ALL, 55% (15% to 92%) for CLL, 26% (19% to 33%) for multiple myeloma, 52% (33% to 71%) for NHL, and 37% (20% to 56%) for HL.
Acute Myelogenous Leukemia
DLI for patients with relapsed acute myelogenous leukemia (AML) after allogeneic HSCT has resulted in overall remission rates ranging from 15% to 42%, with an OS of approximately 15% to 20%. (For comparison, a second HSCT in this group of patients results in 10% to 35% long-term survival with a treatment-related mortality of approximately 50%.) Patients with lower initial disease burden, reduction in the tumor burden with chemotherapy before DLI, and favorable cytogenetics appear to have more benefit with DLI with relapsed AML after HSCT.
A large retrospective analysis from the European Blood and Marrow Transplant Group compared OS in 399 patients with AML with posttransplant relapse who either were treated with DLI (n=171) or were not (n=228) (Schmid, 2007). Patients who received DLI had an improved 2-year OS compared with those who did not, 21%±3% versus 9%±2%, respectively (p<0.001).
A 2015 large retrospective series from the Center for International Blood and Marrow Transplant Research (CIBMTR) reported outcomes of 1788 AML patients who relapsed after allogeneic HSCT in CR1 or CR2, among whom 1231 (69%) received subsequent intensive therapy that included DLI (Bejanyan, 2015). Among the 1231 patients who received treatment, 660 (54%) received chemotherapy alone; 202 (16%) received DLI with or without chemotherapy; and, 369 (30%) received a second allogeneic HSCT with or without additional chemotherapy or DLI. Among all patients who received DLI, 87 (33%) survived more than 1 year after relapse; median survival was 7 months, with a range of 1 to 177 months. Cell-based therapy (DLI or second HSCT) resulted in significantly better postrelapse OS compared with those who received chemotherapy alone. These results are consistent with other reports of DLI in patients who relapse after allogeneic HSCT to treat AML.
The literature for myelodysplasia (MDS) and other myeloproliferative diseases treated with DLI either after relapse or for mixed chimerism consists of small sample sizes, inconsistent pre-DLI therapy, and varied DLI cell doses, making it difficult to draw definite conclusions on outcomes (Tomblyn, 2008). However, it appears some patients attain durable remissions with DLI after posttransplant relapse (Tomblyn, 2008).
Warlick et al reported CR after DLI in 49% of 35 patients with relapsed nonchronic myelogenous leukemia, including AML and MDS, after allogeneic HSCT (Warlick, 2012). OS at 1 year was 30% and 19% at 2 years. The authors reported a lower dose regimen of DLI was more tolerable and reduced graft-versus-host disease (GVHD) occurrence to 25% compared with 66% with higher dose DLI.
An analysis from the German Cooperative Transplant Study Group reported outcomes among a cohort of patients (N=154) who relapsed after undergoing allogeneic HSCT to treat AML (n=124), MDS (n=28), or myeloproliferative syndrome (n=2) (Schroeder, 2015). All patients received a median of 4 courses of azacitidine and DLI was administered to 105 (68%). OS among all patients was 29%±4% at 2-year follow-up, which compares favorably with other reports. The overall incidence of acute GVHD based on the total cohort (N=154) was 23%, and 31% in those given DLI (n=105).
Acute Lymphoblastic Leukemia
The graft-versus-tumor effect is thought to be less robust in patients with ALL than in the myeloid leukemias. Small studies have reported response rates to DLI ranging from 0% to 20% and OS rates of less than 15% (Deol, 2010). By comparison, a second allogeneic HSCT provides a 5-year OS of approximately 15% to 20%, with a treatment-related mortality rate of approximately 50% (Deol, 2010).
The clinically evident graft-versus-leukemia effect of DLI requires weeks to months to become apparent, and, as ALL is a rapidly proliferating disease, DLI only is unable to control the disease without a significant reduction in leukemia burden before DLI. Management of patients with relapsed ALL leading to the best OS is with a combination of salvage chemotherapy and DLI. Although it is not clear whether DLI adds benefit to salvage chemotherapy, long-term survivors have been reported with relapsed ALL who received both chemotherapy and DLI (Tomblyn, 2008).
Lymphomas
Studies in which patients received DLI for lymphomas consist of small numbers of patients and various histologies (both HL and high- and low-grade NHL).
In general, the highest response rates have been seen in the indolent lymphomas. For NHL, too few patients have been reported with any single histologic subtype of lymphoma to give adequate information of the benefit of DLI for a specific lymphoma subtype (Tomblyn, 2008).
The largest series reported for NHL (N=21) using DLI showed response rates in 3 of 9 patients with high-grade NHL, 1 of 2 patients with mantle cell lymphoma, and 6 of 10 patients with low-grade disease (Morris, 2004).
A series of 14 patients with multiply relapsed HL who received reduced-intensity conditioning allogeneic HSCT and DLI showed a CR of 57% and survival at 2 years of 35% (Peggs, 2007).
Genetic Modification of Donor Lymphocytes
In an effort to control GVHD, a group in Italy explored using genetically modified lymphocytes engineered to express the suicide gene thymidine kinase of herpes simplex virus (Ciceri, 2007). These lymphocytes were infused into 23 patients with various hematologic malignancies who relapsed after an allogeneic HSCT. Six patients died of progressive disease within 4 weeks of infusion. Eleven patients experienced disease response (CR in 6, partial remission in 5). Three patients remained alive in CR at a median of 471 days. Twelve patients were evaluable for GVHD, 3 of whom developed acute or chronic GVHD, which was successfully treated with ganciclovir. Overall, evidence is insufficient to permit conclusions on the use of genetic modification of donor lymphocytes.
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
An observational study comparing different treatments for relapse reported on 147 consecutive patients who relapsed after allogeneic HSCT for myelodysplastic syndrome (Guieze, 2015). Sixty-two patients received HSCT or DLI, 39 received cytoreductive treatment, and 46 were managed with palliative or supportive care. Two year rates of OS were 32%, 6%, and 2%, respectively (p<.001). In multivariate analysis, 4 factors adversely influenced 2-year rates of OS: history of acute graft-versus-host disease (hazard ratio [HR], 1.83; 95% CI, 1.26 to 2.67; p=0.002), relapse within 6 months (HR=2.69; 95% CI, 0.82 to 3.98; p<0.001), progression to acute myeloid leukemia (HR=2.59; 95% CI, 1.75 to 3.83; p<0.001), and platelet count less than 50 g/L at relapse (HR=1.68; 95% CI, 1.15 to 2.44; p=0.007). HSCT or DLI was found to be an independent factor that favorably impacts OS (HR=0.40; 95% CI, 0.26 to 0.63; p<0.001).
There are a few nonrandomized comparative studies and numerous case series of DLI treatment for various hematologic malignancies and other myeloproliferative disorders. The nonrandomized studies, in patients with acute leukemia and myelodysplastic syndrome, report higher response rates for patients treated with DLI compared to alternatives. The case series report response rates that are higher than expected for relapsed disease from historical controls. Although there are no high-quality RCTs for DLI treatment, this evidence allows the conclusion that response rates are improved with DLI treatment for patients with previous HSCT treatment and relapsed disease.
Modified Donor Lymphocyte Infusion
In a phase 2 study, donor lymphocytes were treated with rapamycin ex vivo to produce rapamycin-resistant DLIs (Fowler, 2013). Forty patients undergoing low-intensity HSCT for hematologic malignancy were treated preemptively with chemotherapy and DLI. There were no infusional toxicities or serious events attributable to DLI. Classical acute CVHD occurred in 4 of 40 patients. By the end of the study (follow-up range, 42-84 months) 18 of 40 patients remained in sustained remission.
A phase 1 study evaluated patient response to infusion of donor lymphocytes expressing the herpes simplex virus thymidine kinase suicide gene (Hashimoto, 2015). Three patients (2 with malignant lymphomas, 1 with acute myeloid leukemia) were enrolled in the trial and received a single DLI. No local or systemic toxicity related severe GVHD requiring systemic steroid and/or ganciclovir administration. TK cells were detected in the peripheral blood of all 3 patients by PCR, but did not persist longer than 28 days to the gene-transfer procedure was observed. Two patients achieved stable disease. No patient had severe GVHD requiring systemic steroid and/or ganciclovir administration. TK cells were detected in the peripheral blood of all 3 patients by PCR, but did not persist longer than 28 days.
These early phase studies are insufficient to determine the efficacy of modified DLI in the treatment of hematologic malignancies. Randomized studies comparing modified DLI to standard treatment would be necessary to determine efficacy.
2017 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.
2018 Update
A literature search conducted using the MEDLINE database through January 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.
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References: |
1997 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 22. Anderlini P, Acholonu SA, et al.(2004) Donor leukocyte infusions in relapsed Hodgkin's lymphoma following allogeneic stem cell transplantation: CD3+ cell dose, GVHD and disease response. Bone Marrow Transplant, 2004; 34:511-4. Ballen KK, Becker PS, Emmons RV et al.(2002) Low-dose total body irradiation followed by allogeneic lymphocyte infusion may induce remission in patients with refractory hematologic malignancy. Blood 2002; 100(2):442-50. Bejanyan N, Weisdorf DJ, Logan BR, et al.(2015) Survival of patients with acute myeloid leukemia relapsing after allogeneic hematopoietic cell transplantation: a center for international blood and marrow transplant research study. Mar 2015;21(3):454-459. PMID 25460355 Bensinger WI, Buckner CD, Anasetti C, et al.(1996) Allogeneic marrow transplantation for multiple myeloma: an analysis of risk factors on outcome. Blood. Oct 1 1996;88(7):2787-2793. PMID 8839877 Choi SJ, Lee JH, Lee JH et al.(2004) Treatment of relapsed acute myeloid leukemia after allogeneic bone marrow transplantation with chemotherapy followed by G-CSF-primed donor leukocyte infusion: a high incidence of isolated extramedullary relapse. Leukemia 2004; 18(11):1789-97. Ciceri F, Bonini C, Marktel S, et al.(2007) Antitumor effects of HSV-TK-engineered donor lymphocytes after allogeneic stem-cell transplantation. Blood. Jun 1 2007;109(11):4698-4707. PMID 17327416 Collins RH, Goldstein S, Giralt S, et al.(2000) Donor leukocyte infusions in acute lymphocytic leukemia. BMT 2000; 26:511-16. Collins RH, Jr., Shpilberg O, Drobyski WR, et al.(1997) Donor leukocyte infusions in 140 patients with relapsed malignancy after allogeneic bone marrow transplantation. J Clin Oncol. Feb 1997;15(2):433-444. PMID 9053463 Dazzi F, Szydlo RM, Cross NC, et al.(2000) Durability of responses following donor lymphocyte infusions for patients who relapse after allogeneic stem cell transplantation for chronic myeloid leukemia. Blood. Oct 15 2000;96(8):2712-2716. PMID 11023502 Deol A, Lum LG.(2010) Role of donor lymphocyte infusions in relapsed hematological malignancies after stem cell transplantation revisited. Cancer Treat Rev. Nov 2010;36(7):528-538. PMID 20381970 Depil S, Deconinck E, Milpied N et al.(2004) Donor lymphocyte infusion to treat relapse after allogeneic bone marrow transplantation for myelodysplastic syndrome. Bone Marrow Transplant 2004; 33(5):531-4. Djulbegovic B, Seidenfeld J, Bonnell C et al.(2003) Nonmyeloablative allogeneic stem-cell transplantation for hematologic malignancies: a systematic review. Cancer Control 2003; 10(1):17-41. 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PMID 17341269 Guglielmi C, Arcese W, Dazzi F, et al.(2002) Donor lymphocyte infusion for relapsed chronic myelogenous leukemia: prognostic relevance of the initial cell dose. Blood. Jul 15 2002;100(2):397-405. PMID 12091328 Guieze R, Damaj G, Pereira B, et al.(2015) Management of myelodysplastic syndrome relapsing after allogeneic hematopoietic stem cell transplantation: a study by the French Society of Bone Marrow Transplantation and Cell Therapies. Biol Blood Marrow Transplant. Aug 6 2015. PMID 26256942 Guieze R, Damaj G, Pereira B, et al.(2015) Management of myelodysplastic syndrome relapsing after allogeneic hematopoietic stem cell transplantation: a study by the French Society of Bone Marrow Transplantation and Cell Therapies. Biol Blood Marrow Transplant. Aug 6 2015. 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Nov 15 1997;90(10):4206-4211. PMID 9354693 Lokhorst HM, Schattenberg A, Cornelissen JJ, et al.(2000) Donor lymphocyte infusions for relapsed multiple myeloma after allogeneic stem-cell transplantation: predictive factors for response and long-term outcome. J Clin Oncol. Aug 2000;18(16):3031-3037. PMID 10944138 Luznik L, Fuchs EJ.(2002) Donor lymphocyte infusions to treat hematologic malignancies in relapse after allogeneic blood or marrow transplantation. Cancer Control 2002; 9:123-37. Martin P, Chadburn A, et al.(2008) Intensive treatment strategies may not provide superior outcomes in mantle cell lymphoma: overall survival exceeding 7 years with standard therapies. Ann Oncol, 2008; Mar 17 [epub ahead of print]. Morris E, Thomson K, Craddock C, et al.(2004) Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. Blood. Dec 15 2004;104(13):3865-3871. 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PMID 25540937 Simula MP, Marktel S, Fozza C, et al.(2007) Response to donor lymphocyte infusions for chronic myeloid leukemia is dose-dependent: the importance of escalating the cell dose to maximize therapeutic efficacy. Leukemia. May 2007;21(5):943-948. PMID 17361226 Tomblyn M, Lazarus HM.(2008) Donor lymphocyte infusions: the long and winding road: how should it be traveled? Bone Marrow Transplant. Nov 2008;42(9):569-579. PMID 18711351 van den Brink MR, Porter DL, Giralt S, et al.(2010) Relapse after allogeneic hematopoietic cell therapy. Biol Blood Marrow Transplant. Jan 2010;16(1 Suppl):S138-145. PMID 19857588 Warlick ED, DeFor T, Blazar BR, et al.(2012) Successful remission rates and survival after lymphodepleting chemotherapy and donor lymphocyte infusion for relapsed hematologic malignancies postallogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. Mar 2012;18(3):480-486. PMID 22155141 Zhou Y, Zhang L, et al.(2008) Immunotherapy in mantle cell lymphoma: Anti-CD20-based therapy and beyond. Am J Hematol, 2008; 83:144-9. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |