Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow. Normal blasts develop into white blood cells that fight infection. The symptoms of CML are caused by the replacement of normal bone marrow with leukemic cells, resulting in fewer red blood cells, platelets, and normal white blood cells.
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 exact diagnosis date is not known, use the process described in General Instructions, Guidelines for Completing Forms
Question 302: Was therapy given prior to this infusion?
Specify if therapy to treat CML was given prior to the current infusion. If treatment was not given prior to the current infusion or it is unknown, report No. If this is a subsequent infusion and treatment was not given prior to the subsequent infusion (i.e., only given prior to the previous infusion), report No.
Questions 303 – 304: Specify the therapy for CML (check all that apply)
Select all the therapy given to treat CML prior to the current infusion.
If the recipient’s treatment consisted of a combination of chemotherapeutic agents, check the Combination chemotherapy box and each drug included in the combination from the list provided.
If a drug was given but not listed as an option on the form, select Other therapy and specify.
- Example 1: If the recipient received a combination of interferon and cytarabine, check all of the following: Combination chemotherapy, Interferon-α, and Other therapy – specify ‘cytarabine’.
Question 305: 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. Refer to the CML Response Criteria section for definitions of each response.
Question 306: Specify level of response
If the recipient’s best response to therapy is Complete hematologic remission (CHR) or Chronic phase (CP), specify the cytogenetic / molecular response. Refer to table 1 below for definitions of cytogenetic and molecular responses.
The responses below are listed from most favorable (complete molecular remission) to least favorable (no cytogenetic response). Report the most favorable response achieved.
- Example 2: If a recipient has achieved a major molecular remission by PCR testing as well as a complete cytogenetic response by karyotyping / FISH, report the response as Major molecular remission.
Table 1. Definitions of Cytogenetic and Molecular Responses to Therapy
| Response | Definition |
|---|---|
| Complete molecular remission (most favorable) |
0% BCR / ABL transcripts detected in peripheral blood or bone marrow |
| Major molecular remission | > 0 – 0.1% BCR / ABL transcripts detected in peripheral blood or bone marrow |
| Complete cytogenetic response | 0% Ph+ cells detected in bone marrow |
| Partial cytogenetic response | > 0 – 35% Ph+ cells in bone marrow |
| Minor cytogenetic response | > 35 – 65% Ph+ cells in bone marrow |
| Minimal cytogenetic response | > 65 – 95% Ph+ cells in bone marrow |
| No cytogenetic response (least favorable) |
> 95% Ph+ cells in bone marrow. |
Definitions taken from Hughes, T. P., Ross, D. M. & Melo, J. V. Handbook of chronic myeloid leukemia. (Adis, 2014).
Question 307: Specify blast phase phenotype
Assessments performed on the bone marrow or peripheral blood may be used to determine the blast phenotype at the time of the pre-infusion disease status.
Indicate the phenotype detected prior to infusion. If the blast phase phenotype cannot be determined, seek clinician clarification prior to reporting Unknown.
Question 308: Number
Indicate the number of times the recipient has been in the disease phase reported above.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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