Q480 – 483: Other Leukemia

Question 1: Date of diagnosis of primary disease for infusion

Report the date of the first pathological diagnosis (e.g., bone marrow or tissue biopsy) of the disease. Enter the date the sample was collected for examination. If the diagnosis was determined at an outside center, and no documentation of a pathological or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. Do not report the date symptoms first appeared.

If the other leukemia is CLL and CLL transformed to DLBCL (Richter syndrome), report the diagnosis date of DLBCL and the primary disease for infusion as Non-Hodgkin lymphoma above. Ensure the Hodgkin / Non- Hodgkin Lymphoma section is completed. The CLL diagnosis is captured in the Hodgkin / Non-Hodgkin Lymphoma section.

If the exact diagnosis date is not known, use the process described in General Instructions, Guidelines for Completing Forms.

Questions 480 – 481: Specify the other leukemia classification

CIBMTR captures the classification of other leukemia based on the World Health Organization (WHO) 2022. Report the other leukemia disease classification at diagnosis. See below for general information about the other leukemia classifications listed on the form:

• CLL, or chronic lymphocytic leukemia, is characterized by ≥ 5 × 10[^9]/L monoclonal lymphocytes with a CLL phenotype (usually co-expressed CD5 and CD23). The term SLL, or small lymphocytic lymphoma, is used for non-leukemic cases with the tissue morphology and immunophenotype of CLL.
• Hairy cell leukemia is characterized by the presence of abnormal B-lymphocytes in the bone marrow, peripheral blood, and spleen.
• PLL, or prolymphocytic leukemia, is a type of CLL and is characterized by increased presence of immature prolymphocytes in the bone marrow and peripheral blood.

If the subtype is not listed, report as Other leukemia and specify the disease.

Question 482: Was any 17p abnormality detected?

Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality that reflects the recipient’s disease. Testing methods you may see include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information about cytogenetic testing and terminology, see Appendix C: Cytogenetics.

Indicate if cytogenetic studies detected any 17p abnormality at any time prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given).

If cytogenetic studies did not detect any 17p abnormality at any time prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given) or is unknown, select No.

!CLL with Richter’s Transformation
If the recipient is receiving an infusion for CLL and there was Richter’s transformation to lymphoma, the primary disease for infusion should be reported as lymphoma.

Question 483: What was the disease status?

This data field is intended to capture the pre-infusion disease status, based on clinical / hematologic and / or radiologic (if applicable) assessments. If the primary disease for infusion is CLL or CLL / SLL, refer to the CLL Response Criteria section for definitions of each response. If the primary disease for infusion is Hairy Cell Leukemia, refer to the response criteria provided below. If the primary disease is not CLL, CLL / SLL, or Hairy Cell Leukemia, use the criteria for the leukemia that most closely resembles the disease for which this form is being completed. For questions, contact the CIBMTR Customer Service Center.

Report the disease status prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy).

Disease Status of Hairy Cell Leukemia¹

• Complete remission
  • Disappearance of all evidence of disease.
  • Requires all of the following:
    • Neutrophils ≥ 1.5 × 10⁹
    • Hemoglobin ≥ 11.0 g/dL (without transfusion)
    • Platelets ≥ 100 × 10⁹/L
    • Absence of hairy cells on peripheral blood smear and on bone marrow examination
    • No palpable lymphadenopathy or hepatosplenomegaly
• Partial remission (PR)
  • Requires all of the following:
    • ≥ 50% reduction in the absolute hairy cell count in the peripheral blood and the bone marrow
    • ≥ 50% improvement of all cytopenias
    • ≥ 50% reduction in abnormal lymphadenopathy or hepatosplenomegaly
• Stable disease (SD)
  • Not meeting the criteria for any of the other disease response criteria.
• Progressive disease (Prog)
  • Requires one or more of the following:
    • ≥ 25% increase in the absolute hairy cell count in the peripheral blood and/or bone marrow
    • ≥ 25% decrease in any of the hematologic parameters (i.e., neutrophils, hemoglobin or platelets)
    • ≥ 25% increase in abnormal lymphadenopathy or hepatosplenomegaly
• No treatment
  • The recipient was diagnosed with hairy cell leukemia and never treated.
• Relapse (untreated)
  • Relapse after CR:
    • Reappearance of hairy cells in the peripheral blood smear and/or bone marrow (regardless of the degree of infiltration)
    • Development of peripheral blood cytopenias
    • Splenomegaly
  • Relapse after PR:
    • ≥ 50% increase of residual hairy cells in the marrow
    • Development of cytopenias
    • Splenomegaly insufficient to qualify as PR
      OR
    • Reappearance of hairy cells in the bone marrow of those patients who had been classified as partial responders based on residual splenomegaly only

¹ Saven, A., Burian, C., Koziol, J. A., & Piro, L. D. (1998). Long-term follow-up of patients with hairy cell leukemia after cladribine treatment. Blood, 92(6), 1918-1926.

Other leukemia

To determine the disease status, use the criteria for the leukemia that most closely resembles the disease for which this form is being completed. For questions, contact the CIBMTR Customer Service Center.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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