Q166 – 223: Pre-HCT or Pre-Infusion Therapy

!Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and the Lymphoma Pre-Infusion (2018) form was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent Lymphoma Pre-Infusion (2018) Form . Report from post previous infusion to time of preparative regimen / lymphodepleting therapy (or infusion) for the current HCT or cellular therapy. If no Lymphoma Pre-Infusion (2018) Form was completed previously, all lines of therapy from original diagnosis to current preparative regimen / lymphodepleting therapy (or infusion) will have to be completed.

*Lymphoma Transformation
If the recipient’s lymphoma histology transformed between diagnosis and the start of the preparative regimen, all therapy administered from diagnosis (of the original lymphoma) until the start of the preparative regimen / lymphodepleting therapy should be reported.

*Richter’s Transformation
If completing the form for a recipient whose disease has undergone Richter’s transformation prior to infusion, only report therapy administered since the transformation to lymphoma on the Lymphoma Pre-Infusion (2018) Form. Any therapy given prior to transformation will be reported on the CLL Pre-Infusion (2013) Form.

A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, a new line of therapy should be reported. Additionally, if therapy is changed because a favorable disease response was not achieved, a new line of therapy should be reported. Refer to Lines of Therapy reporting instruction overview for more information.

Question 166: Was therapy given?

Indicate if the recipient received treatment for their primary disease between diagnosis and the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given). This includes systemic chemotherapy, immunotherapy, intrathecal therapy, radiation therapy, surgery, and cellular therapies. Do not report a prior infusions, including HCT and CT.

Specify if therapy was given to treat lymphoma at any time prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given). If therapy was not given or it is unknown, report No.

*Reporting Multiple Lines of Therapy
Complete questions Systemic therapy through Date of relapse / progression for each line of therapy administered by adding an additional instance in FormsNet3^SM.

Question 167: Systemic therapy

Systemic therapy is delivered via the blood stream and distributed throughout the body. Therapy may be injected into a vein / central line or given orally. Do not report intrathecal therapy as systemic therapy.

Indicate if systemic therapy was administered as part of the line of therapy being reported.

Questions 168 – 169: Date therapy started

Indicate whether the therapy start date is known. If the therapy start date is Known, report the date the recipient began this line of therapy.

If the start date is partially known (e.g., the recipient started in mid-July 2010), use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

*Zynlonta (Ioncastuximab) End Date
When only a single cycle of the drug Zynlonta (Ioncastuximab) is given, report the therapy end date as the date 21 days post the therapy start date. If Zynlonta is given in multiple cycles, use the standard reporting instructions for reporting the therapy end date of multiple cycles.

Questions 170 – 171: Date therapy stopped

Indicate if therapy stop date is known. If Known, report the end date of the therapy being reported.

If the therapy is being given in cycles, report the date the recipient started the last cycle for this line of therapy. Otherwise, report the final administration date for the therapy being reported.

If the stop date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 172 – 173: Number of cycles

Systemic therapy is usually administered in cycles with rest periods in-between. This enables cancer cells to be attacked at vulnerable times and provides healthy cells with adequate time to recover from the damage sustained during therapy. A cycle can last one or more days and can repeat weekly, bi-weekly, or monthly. A single systemic therapy course may consist of multiple cycles.

Indicate whether the number of cycles is known. If Known, enter the number of cycles the recipient received.

If therapy is not being administered in cycles (e.g., daily chemotherapy), report Unknown.

*BEACOPP
The BEACOPP regimen may be reported as Standard or Dose escalated. Select the option most consistently with the recipient’s treatment guidelines. If it is not clear which option to report, consult the physician.

Questions 174 – 175: Was a standard drug regimen given?

Systemic chemotherapy / immunotherapy may involve administration of multiple drugs / agents during the line of therapy. Rather than reporting each drug separately, standard combination regimens should be reported using the options listed on the form, if available. Specify if the therapy administered was a standard drug regimen. If the recipient’s line of therapy included one of the regimens listed, report Yes and indicate the regimen that was given.

Only one regimen may be reported. Generally, each regimen should be reported as a separate line of therapy. However, if the recipient received a regimen specified as well as additional systemic therapy drugs as part of the line of therapy being reported (i.e., Polatuzumab + Bendamustine and Rituximab (BR)), report the standard regimen and specify the additional drugs in Were systemic drugs given below.

Questions 176 – 178: Were systemic drugs given?

This question is intended to capture systemic therapy drugs / agents not already reported as part of the standard drug regimen, as reported above. If part or all the recipient’s regimen can be reported as a standard drug regimen, report them in the questions above and do not report them again in this question.

Specify if systemic drugs were given as part of this line of therapy, using the following guidelines:

Report Yes in the following scenarios:

• The recipient received systemic chemotherapy drugs not already reported as a standard drug regimen (i.e., only Pembrolizumab administered)
• The recipient received additional systemic chemotherapy drugs in addition to the standard drug regimen reported above (i.e., Polatuzumab + Bendamustine and Rituximab (BR) – Polatuzumab would be reported as systemic drugs and Bendamustine and Rituximab (BR) would be reported as a standard drug regimen)
  

Report No in the following scenarios:

• All systemic therapy drugs given as part of the line of therapy being reported were included in the standard regimen as reported above indicated
• Systemic drugs were not given as part of the line of therapy being reported (i.e., only radiation administered)
  

If the administered systemic chemotherapy drug (or drugs) is not listed as an option, select Other systemic therapy and specify. Only report systemic chemotherapy drugs.

Question 179: Was this line of therapy given for stem cell mobilization (priming)?

Indicate if the line of therapy reported was given for stem cell priming.

For example, R-ICE (rituximab, ifosfamide, carboplatin, and etoposide) may be used in a recipient with lymphoma to collect their peripheral blood stem cells (PBSCs) as they recover their white blood count.

*Multiple intrathecal Therapies
If a recipient receives multiple intrathecal therapies (i.e., IT methotrexate and IT cytarabine) as part of a single line of therapy, report each intrathecal therapy as a separate line.

Question 180: Intrathecal therapy

Intrathecal therapy refers to chemotherapy administered via lumbar puncture to treat or prevent leukemic blasts in the central nervous system. Indicate if intrathecal therapy was given as part of the line of therapy being reported.

Question 181: Reason for intrathecal therapy

Intrathecal therapy may be given to prevent disease in the central nervous system. It may also be given as treatment once disease has been detected. Indicate the reason intrathecal therapy was given. Report Unknown if the reason cannot be determined.

Questions 182 – 183: Date therapy started

Indicate whether the therapy start date is known. If the therapy start date is Known, report the date the recipient began this line of therapy.

If the start date is partially known (e.g., the recipient started in mid-July 2010), use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 184-185: Date therapy stopped

Indicate if therapy stop date is known. If Known, report the final administration date.

If the stop date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 186 – 187: Specify intrathecal therapy

Specify the drug given as intrathecal therapy during the line of therapy being reported. If the drug is not listed as an option, select Other intrathecal therapy and specify the drug.

*Multiple intraocular Therapies
If a recipient receives multiple intraocular therapies as part of a single line of therapy, report each intraocular therapy as a separate line.

Question 188: Intraocular therapy

Intraocular therapy refers to chemotherapy administered via injection to the eye. Specify if intraocular therapy was given as part of the line of therapy being reported.

Question 189: Reason for intraocular therapy

Intraocular therapy may be given to prevent disease in the eye. It may also be given as treatment once disease has been detected. Indicate the reason intraocular therapy was given. Report Unknown if the reason cannot be determined.

Question 190-191: Date therapy started

Indicate whether the therapy start date is known. If the therapy start date is Known, report the date the recipient began this line of therapy.

If the start date is partially known (e.g., the recipient started in mid-July 2010), use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 192 – 193: Date therapy stopped

Indicate if therapy stop date is known. If Known, report the final administration date.

If the stop date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 194 – 195 Specify intraocular therapy

Specify the drug given as intraocular therapy during the line of therapy being reported. If the drug is not listed as an option, select Other intraocular therapy and specify the drug.

Question 196: Radiation therapy

Radiation therapy utilizes high-energy x-rays, gamma rays, electron beams, or proton beams to kill cancer cells. Radiation therapy may be used to kill cells that have invaded other tissues and lymph nodes. Radiation therapy may be given in conjunction with systemic chemotherapy or as a separate line of therapy. Specify if the recipient received radiation as part of the line of therapy being reported.

If radiation therapy was given during or adjacent to administration of systemic therapy, report them together as single line of therapy on the form. Otherwise, capture the radiation treatment as a separate line of therapy.

Questions 197 – 198: Date therapy started

Indicate whether the therapy start date is known. If the therapy start date is Known, report the date the recipient began this line of therapy.

If the start date is partially known (e.g., the recipient started in mid-July 2010), use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 199 – 200: Date therapy stopped

Indicate if therapy stop date is known. If Known, report the final administration date.

If the stop date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 201: What was the extent of the radiation field?

Indicate the extent of the radiation field.

Questions 202 – 203: Specify site(s) of radiation therapy (check all that apply)

Report all sites of radiation therapy administered between the reported start and stop dates for this line of therapy. If Other site is selected, specify all other sites.

Question 204: Dose per fraction

Enter the dose per fraction in either grays (Gy) or centigrays (cGy) for the reported line of therapy.

Question 205: Total number of fractions

Enter the total number of fractions (treatments) of radiation that were administered for the reported line of therapy. The recipient may receive more than one fraction per day (hyperfractionation).

Question 206: Total dose

Enter the total dose of radiation given for the reported line of therapy. If radiation was given as a single dose, the amount of radiation delivered in the single dose constitutes the total dose. If the radiation was given in fractionated doses, multiply the total number of fractions by the dose per fraction to determine the total dose. Enter the total dose of radiation in either grays (Gy) or centigrays (cGy).

The dose per fraction multiplied by the total number of fractions must be equal to the total dose reported.

Example 1: Radiation Order: TBI, 200 cGy/day for three days (3 doses)

• Total dose: 200 cGy x 3 doses = 600 cGy
• Report “Total Dose” as: 600 cGy
  

Questions 207 – 208: Specify technique

Indicate the technique used to deliver radiation therapy. If the technique was Other, specify.

Question 209: Surgery

Specify if the recipient underwent surgical treatment for lymphoma as part of the line of therapy being reported.

Do not report the initial diagnostic biopsy, even if surgery was required, as pre-infusion therapy.

Questions 210 – 211: Date of surgery

Indicate whether the surgery date is known. If Known, report the surgery date.

If the date is partially known (e.g., the recipient started in mid-July 2010), use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 212 – 214: Specify site(s) of surgery

Indicate the site(s) of the surgery by reporting Yes or No for Splenectomy _and _Other site. If Yes is reported for Other site, specify the surgery site(s).

Question 215: Photopheresis

Photopheresis involves removing blood from the body, exposing it to psoralen and ultraviolet light, and then reinfusing it. Indicate whether photopheresis was administered as part of the line of therapy being reported.

*Reporting Prior Cellular Therapy as a Line of Therapy
As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion are no longer required to be reported as a line of therapy on the pre-infusion disease specific form.

Question 216: Cellular therapy (e.g., CAR-T cells)

This question is disabled.

Question 217: Best response to line of therapy by CT (radiographic) criteria

Indicate the best response to the line of therapy by CT using the international working group radiographic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. The best response may occur during or after the line of therapy, but prior to starting the next line of therapy.

Report Not assessed if a CT (or a PET / CT with a CT component) was not performed at any time during the line of therapy reported and prior to the initiation of any new therapy.

Question 218: Date assessed

Report the date of the CT (or PET / CT with a CT component) scan used to determine the response reported. If the same response was achieved multiple times during the line of therapy, or after but prior to starting the next treatment, report the date of the first CT (or PET / CT with a CT component) confirming the reported best response.

If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 219: Best response to line of therapy by PET (metabolic) criteria

Indicate the best response to the line of therapy by PET using the international working group metabolic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. The best response may occur during or after the line of therapy, but prior to starting the next line of therapy.

Report Not assessed if a PET (or PET / CT) scan was not performed at any time during the line of therapy being reported and prior to the initiation of any new therapy.

Question 220: Date assessed

Report the date of the PET (or PET / CT) scan used to determine the response reported. If the same response was achieved multiple times during the line of therapy, or after but prior to starting the next treatment, report the date of the first PET (or PET / CT) confirming the reported best response.

If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 221: Was this line of therapy maintenance / consolidation?

Indicate if the reported line of therapy given for maintenance or consolidation. See below for general definitions.

• Consolidation: Once a recipient has achieved a hematologic CR (1st, 2nd, 3rd or greater), they may receive several additional lines of therapy as part of a protocol or to eliminate known minimal residual disease.
• Maintenance: Following induction and consolidation, a recipient may receive low dose chemotherapy over an extended period of time to maintain a CR. Maintenance therapy is usually given as a single drug taken in the outpatient setting when the recipient has no known evidence of disease.

Questions 222 – 223: Did disease relapse / progression occur following this line of therapy?

The intent of this question is to determine if relapse / progression (radiographic or metabolic) occurred during the reported line of therapy, or after, but prior to starting the next treatment. Refer to the international working group criteria provided in LYM Response Criteria section of the Forms Instructions Manual to determine recurrence / progression of disease.

Specify if relapse / progression occurred during the reported line of therapy, or after, but prior to starting the next treatment.

Report Yes if the recipient met the relapse / progression criteria (radiographic or metabolic) or if relapse was detected based on clinical evidence (i.e., palpable nodes detected on the physician’s exam, abnormal labs, etc.) after starting this line of therapy and prior to starting a subsequent line of therapy. If relapse / progression occurred, specify the date of relapse / progression. If there are multiple relapses / progressions, report the first assessment confirming relapse / progression.

Report No if the recipient’s disease did not relapse or progress during the reported lie of therapy, or after, but prior to starting the next treatment or if relapse / progression occurred after beginning a subsequent line of therapy. This episode of relapse / progression will be captured in the subsequent line of therapy reported.

If this is the last line of therapy administered prior to infusion, only report Yes if relapse occurred prior to infusion. Relapse occurring after the infusion date will be captured on the Lymphoma Post-Infusion ( 2118) Form.

Section Updates:

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