BlueCross and BlueShield of Montana Medical Policy/Codes
Stem-Cell Transplant for Acute Lymphocytic Leukemia (ALL)
Chapter: Transplant
Current Effective Date: December 27, 2013
Original Effective Date: July 09, 2008
Publish Date: September 27, 2013
Revised Dates: March 1, 2010, July 1, 2011, March 22, 2012; September 10, 2013
Description

Acute lymphocytic leukemia (ALL) results from an acquired (not inherited) genetic injury to the DNA (Deoxyribonucleic acid) of a single cell in the bone marrow.  The effects are:

  • The uncontrolled and exaggerated growth and accumulation of cells called "lymphoblasts" or "leukemic blasts," which fail to function as normal blood cells, and
  • The blockade of the production of normal marrow cells, leading to a deficiency of red cells (anemia), platelets (thrombocytopenia), and normal white cells (especially neutrophils, i.e., neutropenia) in the blood.

ALL occurs in multiple forms that vary with regard to cellular morphology, cytochemistry, immunophenotype, cytogenetic abnormalities, and other prognostic features.  Although adult and childhood forms of ALL vary in the distribution of these prognostic features, there is considerable overlap, particularly among late adolescents and young adults.  Consequently, no clear age demarcation divides the adult and childhood forms.

However, in general, adult ALL is characterized by a predominance of immature and pleomorphic cells, more frequent co-expression of myeloid markers, a greater percentage of leukemias derived from T-cells rather than B-cells, and a higher incidence of cytogenetic abnormalities with negative prognostic implications (such as the Philadelphia chromosome).  In contrast, childhood ALL cells usually have a more mature morphology, and infrequently are of T-cell origin or positive for myeloid markers or the Philadelphia chromosome.  As a consequence of these differences, the adult and childhood forms of ALL respond differently to treatment and vary in their risk for relapse once remission is achieved.  For example, childhood ALL is a highly curable disease, with long-term survival rates ranging from 60%–85%.  Similar therapy regimens have had less favorable outcomes in adult ALL.  Approximately 65%–90% of those with adult ALL achieve an initial complete remission, but only 20%–30% become long-term survivors.

Risk factors associated with a *high risk of relapse following initial complete remission includes:

  • Age greater than 15 years;
  • Leukocyte count greater than 10 x 109/L;
  • Extramedullary disease, particularly in the central nervous system;
  • Chromosomal abnormalities, including Philadelphia chromosome;
  • Failure to achieve a complete remission (CR) within six weeks after induction therapy begins.
Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.

Coverage

Coverage for evaluation of and subsequent single treatment by stem-cell transplant (SCT) (using bone marrow, peripheral blood, or umbilical cord blood as a stem-cell source), derived from a specific donor category, and following a chemotherapy regimen for treatment of acute lymphocytic leukemia (ALL) are identified in the grids below.

Children:

Allogeneic

May be considered medically necessary to treat childhood ALL in first complete remission but at high risk of relapse*, or in second, or greater remission or refractory ALL.

Is considered experimental, investigational and unproven to treat relapsing ALL after a prior autologous SCT.

Autologous

 

May be considered medically necessary to treat childhood ALL in first complete remission but at high risk of relapse*, or in second, or greater remission or refractory ALL.

Tandem or Triple Stem-Cell Transplant

Is considered experimental, investigational and unproven. 

Donor Leukocyte Infusion

Is considered experimental, investigational and unproven. 

Adults: 

Allogeneic

May be considered medically necessary to treat adult ALL in first complete remission but at high risk of relapse*, or in second, or greater remissions, or in patients with relapsed or refractory ALL.

Is considered experimental, investigational and unproven to treat relapsing ALL after a prior autologous SCT.

Autologous

 

May be considered medically necessary to treat adult ALL in first complete remission but at high risk of relapse*.

Is considered experimental, investigational and unproven to treat adult ALL in second or greater remission or those with refractory disease.

Tandem or Triple Stem-Cell Transplant

Is considered experimental, investigational and unproven. 

Donor Leukocyte Infusion

Is considered experimental, investigational and unproven.

Rationale

High-dose chemotherapy (HDC) followed by hematopoietic stem-cell (HSC) (i.e., blood or marrow) transplant is an effective treatment modality for many patients with certain malignancies and non-malignancies. The rationale of this treatment approach is to provide a very dose-intensive treatment in order to eradicate malignant cells followed by rescue with peripheral blood or bone marrow stem-cells. 

Childhood ALL

The policy on childhood ALL is based on Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Assessments completed in 1987 and 1990.  In childhood ALL, conventional chemotherapy is associated with complete remission rates of about 95%, with long-term durable remissions of 60%.  Therefore, for patients in a first complete remission (CR1), SCT therapy is considered necessary only in those with risk factors predictive of relapse.  These factors include:

  • Age older than 15 years;
  • Leukocyte count greater than 10 x 109/L;
  • Extramedullary disease, particularly in the central nervous system;
  • Chromosomal abnormalities, including Philadelphia chromosome.

The prognosis after first relapse is related to the length of the original remission.  For example, leukemia-free survival is 40–50% for children whose first remission was longer than three years, compared to only 10–15% for those with early relapse.  Thus, SCT may be a strong consideration in those with short remissions.  At present, the comparative outcomes with either autologous or allogeneic SCT are unknown.

Three reports describing the results of randomized controlled trials (RCTs) that compared outcomes of hematopoietic SCT to outcomes with conventional-dose chemotherapy in children with ALL were identified subsequent to the TEC Assessment.  The children enrolled in the RCTs were being treated for high-risk ALL in CR1 or for relapsed ALL.  These studies reported that overall outcomes after SCT were generally equivalent to overall outcomes after conventional-dose chemotherapy.  While SCT administered in CR1 was associated with fewer relapses than conventional-dose chemotherapy, it was also associated with more frequent deaths in remission (i.e., from treatment-related toxicity).  A more recently published randomized trial (PETHEMA ALL-93, n=106) demonstrated no significant differences in disease-free survival or overall survival rates at median follow-up of 78 months in children with very high-risk ALL in CR1 who received allogeneic or autologous SCT versus standard chemotherapy with maintenance treatment.  Similar results were observed using either intention-to-treat (ITT) or per-protocol (PP) analyses.  However, the authors point out several study limitations that could have affected outcomes including the relatively small numbers of patients, variations among centers in the preparative regimen used prior to SCT, time elapsed between CR and undertaking of assigned treatment and the use of genetic randomization based on donor availability rather than true randomization for patients included in the allogeneic SCT arm.

These results, and reviews of other studies, suggest that while overall and event-free survival are not different after SCT compared to conventional-dose chemotherapy, SCT remains an important therapeutic option in the management of childhood ALL, especially for patients considered at high risk of relapse.  This conclusion is further supported by an evidence-based systematic review of the literature sponsored by the American Society for Blood and Marrow Transplantation (ASBMT).  Other investigators recommend that patients should be selected for this treatment using risk-directed strategies.

Clinical Trials Database for Childhood ALL

A search of the Clinicaltrials.gov database identified four open or active Phase III and IV trials from 2007 of hematopoietic SCT for childhood ALL which are listed below:

  • Phase II/III study of standard and novel conditioning therapy and allogeneic blood or marrow transplantation in patients with severe aplastic anemia or hematologic malignancy (RPCI-RP-9815);
  • Phase III randomized study of induction chemotherapy followed by consolidation and re induction with or without late intensification followed by a maintenance regimen or allogeneic bone marrow transplantation in infants with acute lymphoblastic leukemia (ICU-INTERFANT99);
  • Phase III randomized study of filgrastim (G-CSF)-mobilized peripheral blood SCT versus bone marrow transplantation from HLA-compatible unrelated donors in patients with hematologic malignancies (BMTCTN-0201);
  • Phase III randomized study of nonmyeloablative conditioning comprising low-dose total body irradiation with versus without fludarabine followed by HLA-matched related allogeneic hematopoietic SCT in patients with hematologic malignancies at low or moderate risk for graft rejection (FHCRC-1813.00).

Adult ALL

The policy on adult ALL was initially based in part on a 1998 TEC Assessment of autologous (not allogeneic) SCT.  This Assessment offered the following conclusions:

  • For patients in CR1, the data suggest survival is equivalent after autologous SCT or conventional-dose chemotherapy.  For these patients, the decision between autologous SCT and conventional chemotherapy may reflect a choice between intensive therapy of short duration and longer but less-intensive treatment.
  • In other settings, such as in second (CR2) or subsequent remissions, data were inadequate to determine the relative effectiveness of autologous SCT compared to conventional chemotherapy.

An evidence-based systematic review sponsored by the ASBMT addressed the issue of SCT in adults with ALL.  The ASBMT panel recommends hematopoietic SCT for adults with high-risk disease in CR1, but not for standard-risk patients.  It also recommends SCT for patients in CR2, although data are not available to directly compare outcomes with alternatives.

Based on results from three randomized clinical trials the ASBMT panel concluded that allogeneic SCT is superior to autologous SCT in adult patients in CR1, although available data did not permit separate analyses in high-risk versus low-risk patients.  However, partially conflicting results were reported in a multicenter (35 Spanish hospitals) randomized trial (PETHEMA ALL-93; n=222) published after the ASBMT literature search.  Among 183 high-risk patients in CR1, those with an HLA-identical family donor were assigned to allogeneic SCT (n=84); the remaining cases were randomized to autologous SCT (n=50) or to delayed intensification followed by maintenance chemotherapy up to two years in CR (n=48).  At median follow-up of 70 months, the study did not detect a statistically significant difference in outcomes between all three arms by both per-protocol and intention-to-treat analyses.  However, the authors point out several study limitations that could have affected outcomes including the relatively small numbers of patients, variations among centers in the preparative regimen used prior to SCT, differences in risk group assignment and the use of genetic randomization based on donor availability rather than true randomization for patients included in the allogeneic SCT arm.

An ongoing but not completed phase III randomized study of allogeneic or autologous SCT versus conventional consolidation and maintenance chemotherapy is specific to patients with ALL in CR1 (ECOG-2993).  After induction treatment that included imatinib mesylate for Philadelphia chromosome-positive patients, Philadelphia chromosome-positive patients received autologous or allogeneic SCT followed by imatinib mesylate.  Philadelphia chromosome-negative patients received either conventional consolidation/maintenance therapy or autologous SCT.  The latest update of this study suggests a significant benefit of allogeneic SCT over chemotherapy or autologous SCT in patients with Philadelphia chromosome-negative high-risk ALL, although a final intention-to-treat analysis of the data is pending.

While allogeneic SCT may be an option for some adults with ALL, for several reasons allogeneic transplant remains controversial in the treatment of adults with ALL.  First, the increased morbidity and mortality from GVHD (graft-versus-host disease) limit its use, particularly for older patients.  Second, evidence is scant for a beneficial graft-versus-leukemia effect in this disease to counterbalance the harms from GVHD.  Finally, even for adults who survive the procedure, there is a significant relapse rate, and overall very few adults are long-term disease-free survivors.  Taken together, current evidence supports the use of allogeneic SCT for the poor-risk subgroup of those with ALL in association with the Philadelphia chromosome or in patients with refractory or relapsed ALL.

Two other randomized controlled trials and one large registry-based retrospective review was published on SCT to treat ALL in adults.  These studies did not compare outcome after SCT to outcome after conventional-dose chemotherapy, but rather compared:

  • outcome according to stem-cell source (bone marrow versus peripheral blood);
  • outcome using primed or unprimed peripheral blood stem cells; or
  •  the benefits of adding interleukin-2 as post-transplant therapy.

The results of these studies and several dozen uncontrolled clinical series confirm the existing policy on the use of autologous or allogeneic SCT to treat adult ALL in first or subsequent remission or in relapse (see above).

Clinical Trials Database for Adult ALL

A search of Clinicaltrials.gov shows four active clinical trials from 2007 on hematologic malignancies for adult ALL patients which are listed below:

  • Phase II/III study of standard and novel conditioning therapy and allogeneic blood or marrow transplantation in patients with severe aplastic anemia or hematologic malignancy (RPCI-RP-9815);
  • Phase III randomized study of filgrastim (G-CSF)-mobilized peripheral blood SCT versus bone marrow transplantation from HLA-compatible unrelated donors in patients with hematologic malignancies (BMTCTN-0201); and
  • Phase III randomized study of nonmyeloablative conditioning comprising low-dose total body irradiation with versus without fludarabine followed by HLA-matched related allogeneic hematopoietic SCT in patients with hematologic malignancies at low or moderate risk for graft rejection (FHCRC-1813.00).
  • Phase II/III protocol using busulfan, cyclophosphamide, and melphalan as conditioning therapy for patients receiving SCT for acute leukemia or myelodysplastic syndrome (MDS). It is hypothesized that this new regimen will be well tolerated and curative (0005M52481).

Allogeneic Transplant after Prior Failed Autologous Transplant

A 2000 TEC Assessment focused on allogeneic SCT after a prior failed autologous SCT, in the treatment of a variety of malignancies, including ALL.  The TEC Assessment found that data were inadequate to permit conclusions about outcomes of this treatment strategy.  Published evidence was limited to small, uncontrolled clinical series with short follow-up.  Updated literature searches have not identified any additional evidence to permit conclusions on this use of SCT.

National Comprehensive Cancer Network (NCCN) Guidelines

The NCCN clinical practice guidelines for non-Hodgkin’s lymphoma indicate autologous or allogeneic SCT is appropriate for treatment of poor risk patients with lymphoblastic lymphoma (i.e., when disease is considered to be systemic).  These guidelines are generally consistent with this policy.

Additional Review of Literature Through 2008

Two studies were published on the use of RIC (reduced intensity conditioning) regimens for allogeneic SCT in patients with ALL.  The first was a multicenter single-arm study of patients (n=43, median age 19 years, range 1-55) in second complete remission (CR2).  The three year overall survival rate was 30%, with 100-day and treatment-related mortality rates of 15% and 21%, respectively.  Despite achievement of complete donor chimerism in 100% of the patients, 28 (65%) had leukemic relapse, with 67% ultimately succumbing to their disease.  In a registry-based study, 97 adult patients (median age 38 years, range 17-65) underwent RIC and allogeneic SCT to treat ALL in CR1 (n=28), beyond CR1 (CR2/CR3, n=26/5) and advanced or refractory disease (n=39).  With median follow-up of about three years, in the overall population two year OS was 31%, with non-relapse mortality of 28% and relapse rate of 51%.  In patients transplanted in CR1, overall survival was 52%; in CR2/CR3, it was 27%; in patients with advanced or refractory ALL, overall survival was 20%.  While these data suggest RIC and allogeneic SCT may have some efficacy as salvage therapy in high-risk ALL, they are insufficient to modify any of the policy statements.  Based on currently available data, RIC-allogeneic SCT may be considered medically necessary only in those patients who qualify for a myeloablative allogeneic SCT.  Additional data from comparative studies are necessary to determine whether some patients may benefit from an RIC-allogeneic SCT even though they would not be considered eligible for a myeloablative allogeneic SCT.

A search of the NCI (National Cancer Institute Clinical Trials Database) PDQ® database identified five active phase III trials that involve stem-cell support for patients with ALL (adult or pediatric).  Information on these trials can be accessed at www.cancer.gov .

Tandem or Triple Stem-Cell Transplant and Donor Leukocyte Infusion (DLI) for ALL are considered experimental, investigational, and unproven due to lack of adequate evidence of safety and effectiveness documented in published, peer-reviewed medical literature.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

41.00, 41.01, 41.02, 41.03, 41.04, 41.05, 41.06, 41.07, 41.08, 41.09, 41.91, 99.25, 99.74, 99.79, 204.00, 204.01, 204.02

ICD-10 Codes
C91.00-C91.02, 30250G0, 30250X0, 30250Y0, 30250G1, 30250X1, 30250Y1, 30253G0, 30253X0, 30253Y0, 30253G1, 30253X1, 30253Y1, 6A550ZT, 6A550ZV, 6A551ZT, 6A551ZV
Procedural Codes: 36511, 38204, 38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38220, 38221, 38230, 38232, 38240, 38241, 38242, 38243, 81265, 81266, 81267, 81268, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, 81383, 86805, 86806, 86807, 86808, 86812, 86813, 86816, 86817, 86821, 86822, 86825, 86826, 86849, 86950, 86985, 88240, 88241, S2140, S2142, S2150
References
  1. Autologous Bone Marrow Transplantation in Acute Lymphocytic and Non-Lymphocytic Leukemia Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center (1987 November):243-57.
  2. High-Dose Chemotherapy with Autologous Bone Marrow Transplantation for Acute Lymphocytic and Non-Lymphocytic Leukemia in the First Remission. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center (1990 November):264-73.
  3. Attal, M., Blaise, D., et al. Consolidation treatment of adult acute lymphoblastic leukemia: a prospective, randomized trial comparing allogeneic versus autologous bone marrow transplantation and testing the impact of recombinant interleukin- 2 after autologous bone marrow transplantation. BGMT Group. Blood (1995) 86(4):1619-28.
  4. High-Dose Chemotherapy with Autologous Stem-Cell Support in the Treatment of Adult Acute Lymphoblastic Leukemia. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1998 January) 12(25):1-25.
  5. Wheeler, K.A., Richards, S.M., et al. Bone marrow transplantation versus chemotherapy in the treatment of very high-risk childhood acute lymphoblastic leukemia in first remission: results from Medical Research Council UKALL X and XI. Blood (2000) 96(7):2412-8.
  6. Harrison, G., Richards, S., et al. Comparison of allogeneic transplant versus chemotherapy for relapsed childhood acute lymphoblastic leukaemia in the MRC UKALL R1 trial. Annals of Oncology (2000) 11(8):999-1006.
  7. Lawson, S.E., Harrison, G., et al. The UK experience in treating relapsed childhood acute lymphoblastic leukaeima: a report on the Medical Research Council UK ALLR1 study. British Journal of Haematology (2000) 108(3):531-43.
  8. Uderzo, C. Indications and role of allogeneic bone marrow transplantation in childhood very high risk acute lymphoblastic leukemia in first complete remission. Haematologica (2000) 85(11 suppl):9-11.
  9. Uderzo, C., Dini, G., et al. Treatment of childhood acute lymphoblastic leukemia after the first relapse: curative strategies. Haematologica (2000) 85(11 suppl):47-53.
  10. Gaynon, P.S., Trigg, M.E., et al. Children’s Cancer Group trials in childhood acute lymphoblastic leukemia: 1983-1995. Leukemia (2000) 14(12):2223-33.
  11. Blaise, D., Kuentz, M., et al. Randomized trial of bone marrow versus lenograstim-primed blood cell allogeneic transplantation in patients with early stage leukemia: a report from the Société Française de Greffe de Moelle. Journal of Clinical Oncology (2000) 18(3):537-46.
  12. Blaise, D., Attal, M., et al. Randomized study of recombinant interleukin-2 after autologous bone marrow transplantation for acute leukemia in first complete remission. European Cytokine Network (2000) 11(1):91-8.
  13. Champlin, R.E., Schmitz, N., et al. Blood stem cells compared to bone marrow as a source of hematopoietic cells for allogeneic transplantation. Blood (2000) 95(12):3702-9.
  14. Salvage HDC/AlloSCS for Relapse or Incomplete Remission Following HDC/AuSCS for Hematologic Malignancies. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center. (2000 August) Tab 9.
  15. Collins, R.H., Goldstein, S., et al. Donor leukocyte infusions in acute lymphocytic leukemia. Bone Marrow Transplant (2000 September) 26(5):511-6.
  16. Dombret, H., Gabert, J., et al. Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia–results of the prospective multicenter LALA-94 trial. Blood (2002) 100(7):2357-66.
  17. Hunault, M., Harousseau, J.L., et al. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood (2004) 104(10):3028-37.
  18. Goldstone, A.H., Lazarus, H.J., et al. The outcome of 551 1st CR transplants in adult ALL from the UKALL XII/ECOG 2993 study [abstract]. Blood (2004) 104:178a.
  19. Hahn, T., Wall, D., et al. The role of cytotoxic therapy with hematopoietic stem cell transplantation in the therapy of acute lymphoblastic leukemia in children: an evidence-based review. Biology of Blood and Marrow Transplant (2005) 11(11):823-61.
  20. Ribera, J.M., Oriol, A., et al. Comparison of intensive chemotherapy, allogeneic or autologous stem cell transplantation as post-remission treatment for adult patients with high-risk acute lymphoblastic leukemia. Results of the PETHEMA ALL-93 trial. Haematologica (2005) 90(10):1346-56.
  21. Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Stem Cell Transplant. BCBSA Medical Policy Reference Manual (2005 September) Medicine: 2.03.03.
  22. Hahn, T., Wall, D., et al. The role of cytotoxic therapy with hematopoietic stem cell transplantation in the therapy of acute lymphoblastic leukemia in adults: an evidence-based review. Biology of Blood and Marrow Transplant (2006) 12(1):1-30.
  23. Ribera, J.M., Ortega, J.J., et al. Comparison of intensive chemotherapy, allogeneic, or autologous stem-cell transplantation as postremission treatment for children with very high risk acute lymphoblastic leukemia: PETHEMA ALL-93 trial. Journal of Clinical Oncology (2007) 25(1):16-24.
  24. Gutierrez-Aguirre, C.H., Gomez-Almaguer, D., et al. Non-myeloablative stem cell transplantation in patients with relapsed acute lymphoblastic leukemia: results of a multicenter study. Bone Marrow Transplant (2007) 40(6):535-9.
  25. Mohty, M., Labopin, M., et al. Reduced intensity conditioning allogeneic stem cell transplantation for adult patients with acute lymphoblastic leukemia: a retrospective study from the European Group for Blood and Marrow Transplantation. Haematologica (2008) 93(2):303-6.
  26. Non-Hodgkin’s Lymphoma. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.v.3. (2008) www.nccn.org.
  27. Hematopoietic Stem-Cell Transplantation for Acute Lymphocytic Leukemia. Chicago Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2008 June) Therapy 8.01.32.
History
July 2011 Policy name chaged from general Leukemia SCT to specific Acute Lymphoblastic Leukemia.
March 2012 Policy updated with literature search; references 15 and 23 added, reference 32 updated. No change to policy statements
September 2013 Policy formatting and language revised.  Title changed from "Hematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia" to "Stem-Cell Transplant for Acute Lymphocytic Leukemia (ALL)".  Removed from the medically necessary statement "BCBSMT considers reduced-intensity conditioning allogeneic hematopoietic SCT medically necessary as a treatment of ALL in patients who are in complete marrow and extramedullary first or second remission, and who, for medical reasons, would be unable to tolerate a standard myeloablative conditioning regimen."
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Stem-Cell Transplant for Acute Lymphocytic Leukemia (ALL)