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Center for International Blood and Marrow Transplant Research

PRO Data Collection Protocol

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The CIBMTR collects longitudinal or cross-sectional PRO data from recipients of cellular therapies who are also enrolled in the Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies, and Marrow Toxic Injuries (Research Database protocol). The time points for PRO data collection parallel the time points at which treatment centers submit clinical outcomes data from healthcare records, with an additional time point at 30 days post-treatment for cellular therapy patients. Below are the measures and time points collected for adult HCT and CAR T patients:

Time Points:
  • Pre-infusion
  • Day 30 (CAR T only)
  • Day 100
  • Day 180
  • Year 1
  • Annually
Domains:
  • PROMIS Global
  • PROMIS Physical Function
  • PROMIS Fatigue
  • PROMIS Sleep Disturbance
  • PROMIS Pain Interference
  • PROMIS Anxiety
  • PROMIS Depression
  • PROMIS Cognitive Function
  • PROMIS Ability to Participate in Social Roles and Activities
  • PROMIS Sexual Function Profile
  • COmprehensive Score for financial Toxicity (COST)
  • Occupational functioning, Social determinants of health, Demographics

Research goals

The primary purpose of the PRO Protocol is to have a centralized collection of patient-reported symptoms and functioning to supplement traditional outcomes, such as survival or disease relapse, in registration and other studies. These data may be used in research to:

  • Assess trajectories of patient symptom and functioning overtime
  • Determine and evaluate symptoms and functioning that affect HCT and cellular therapy outcomes
  • Assess long-term outcomes after HCT or cellular therapy

Recipient and donor participation

Any recipient of an unrelated or related HCT or CAR T in a CIBMTR-affiliated center may participate in the PRO protocol. Complete eligibility requirements are outlined in the study protocol.

If the recipient of HCT or cellular therapy does not consent to the Research Database protocol, they may still participate in the PRO protocol, but the use of their data will be limited to CIBMTR and NMDP process improvement analyses or study-specific analysis as laid out in the PRO protocol consent form.

The CIBMTR Survey Research Group identifies, approaches, and obtains consent from eligible recipients. Informed consent is documented in the CIBMTR electronic PRO (ePRO) system. The Survey Research Group centrally collects PRO surveys from participating recipients electronically, on paper, or by phone and follows up with non-responders.

PRO data are collected in the ePRO system and then stored in the CIBMTR database where they can be linked to CIBMTR clinical outcomes data.

Protocol enrollment

Presented here are the number of patients enrolled in the CIBMTR PRO Protocol by type and year of infusion, as of May 20, 2025.

Characteristic Allogeneic Hematopoietic Cell Transplantation Autologous Hematopoietic Cell Transplantation Cellular Therapy Gene Therapy Total
Total no. patients1 637 761 310 3 1711
Year of Infusion - no. (%)
2025 12 (2) 17 (2) 42 (14) 3 (100) 74 (4)
2024 120 (19) 156 (20) 120 (39) 0 (0) 396 (23)
2023 131 (21) 140 (18) 90 (29) 0 (0) 361 (21)
2022 221 (35) 303 (40) 45 (15) 0 (0) 569 (33)
2021 120 (19) 135 (18) 12 (4) 0 (0) 267 (16)
2020 31 (5) 10 (1) 1 (<1) 0 (0) 42 (2)
2019 2 (<1) 0 (0) 0 (0) 0 (0) 2 (<1)

111 HCTs not included in the table due to lack of infusion type information in FormsNet3.

PRO data collected

Presented here are the number of completed PRO surveys available for analysis by infusion-related time point, infusion type, age at transplant, gender, and indication, as of May 20, 2025.

Number (%) of patients who have survey completed at each time point

Characteristic Baseline Day 30 Day 100 Day 180 Year 1 Year 2 Year 3 Year 4 Total
No. of surveys1 337 170 1245 1284 995 632 281 69 5013
No. of centers 20 28 42 43 35 25 24 17 59
Sex - no. (%)
     Male 180 (53) 109 (64) 738 (59) 753 (59) 578 (58) 363 (57) 173 (62) 39 (57) 2933 (59)
     Female 140 (42) 60 (35) 504 (40) 527 (41) 415 (42) 267 (42) 108 (38) 30 (43) 20251 (41)
     Not reported 17 (5) 1 (1) 3 (<1) 4 (<1) 2 (<1) 2 (<1) 0 (0) 0 (0) 29 (1)
Infusion type - no. (%)
     Allo-HCT 149 (44) 0 (0) 400 (32) 332 (33) 332 (33) 223 (35) 123 (44) 48 (70) 1704 (34)
     Auto-HCT 131 (39) 0 (0) 617 (50) 637 (50) 524 (53) 347 (55) 151 (54) 20 (29) 2427 (48)
     Cellular therapy 45 (13) 169 (99) 228 (18) 217 (17) 139 (14) 62 (10) 7 (2) 1 (1) 868 (17)
     Gene therapy 2 (1) 1 (1) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 3 (<1)
     HCT, type not reported 10 (3) 0 (0) 0 (0) 1 (<1) 0 (0) 0 (0) 0 (0) 0 (0) 11 (<1)
Age at infusion - no. (%)                
     18-29 10 (3) 7 (4) 42 (3) 46 (4) 32 (3) 20 (3) 7 (2) 6 (9) 170 (3)
     30-39 18 (5) 3 (2) 65 (5) 68 (5) 53 (5) 31 (5) 15 (5) 6 (9) 259 (5)
     40-49 31 (9) 11 (6) 125 (10) 123 (10) 101 (10) 60 (9) 22 (8) 7 (10) 480 (10)
     50-59 72 (21) 35 (21) 292 (23) 294 (23) 235 (24) 146 (23) 58 (21) 13 (19) 1145 (23)
     60-69 129 (38) 50 (29) 466 (37) 501 (39) 390 (39) 253 (40) 133 (47) 29 (42) 1951 (39)
     ≥70 60 (18) 63 (37) 252 (20) 248 (19) 182 (18) 120 (19) 46 (16) 8 (12) 979 (20)
     Not reported 17 (5) 1 (1) 3 (<1) 4 (<1) 2 (<1) 2 (<1) 0 (0) 0 (0) 29 (1)
Primary disease for which the infusion was performed - no. (%)
Acute myeloid leukemia 62 (18) 0 (0) 179 (14) 196 (15) 153 (15) 95 (15) 51 (18) 33 (48) 769 (15)
Acute lymphoblastic leukemia 17 (5) 0 (0) 46 (4) 47 (4) 37 (4) 24 (4) 19 (7) 6 (9) 196 (4)
Other acute leukemia 1 (<1) 0 (0) 6 (<1) 7 (1) 7 (1) 5 (1) 3 (1) 1 (1) 30 (1)
Chronic myeloid leukemia 4 (1) 0 (0) 8 (1) 10 (1) 9 (1) 6 (1) 4 (1) 1 (1) 42 (1)
Myelodysplastic syndrome 36 (11) 0 (0) 102 (8) 103 (8) 79 (8) 58 (9) 34 (12) 6 (9) 418 (8)
Myeloproliferative neoplasms 12 (4) 0 (0) 23 (2) 26 (2) 20 (2) 12 (2) 4 (1) 0 (0) 97 (2)
Other leukemia 2 (1) 0 (0) 5 (<1) 6 (<1) 2 (<1) 4 (1) 1 (<1) 0 (0) 20 (<1)
Hodgkin lymphoma 7 (2) 0 (0) 32 (3) 32 (2) 26 (3) 17 (3) 6 (2) 0 (0) 120 (2)
Non-Hodgkin lymphoma 77 (23) 168 (99) 350 (28) 345 (27) 245 (25) 135 (21) 45 (16) 6 (9) 1371 (27)
Multiple myeloma / plasma cell disorder 89 (26) 0 (0) 466 (37) 477 (37) 388 (39) 257 (41) 110 (39) 16 (23) 1803 (36)
Other malignancies 2 (1) 0 (0) 7 (1) 7 (1) 5 (1) 2 (<1) 1 (<1) 0 (0) 24 (<1)
Severe aplastic anemia 4 (1) 0 (0) 7 (1) 11 (1) 10 (1) 9 (1) 2 (1) 0 (0) 43 (1)
Sickle cell disease 0 (0) 1 (1) 0 (0) 1 (<1) 1 (<1) 0 (0) 0 (0) 0 (0) 3 (<1)
Paroxysmal nocturnal hemoglobinuria (PNH) 0 (0) 0 (0) 1 (<1) 1 (<1) 1 (<1) 0 (0) 0 (0) 0 (0) 3 (<1)
Autoimmune diseases 3 (1) 0 (0) 7 (1) 9 (1) 9 (1) 5 (1) 1 (<1) 0 (0) 34 (1)
Other non-malignant hematologic disorders 2 (1) 0 (0) 1 (<1) 2 (<1) 1 (<1) 1 (<1) 0 (0) 0 (0) 7 (<1)
Not reported 19 (6) 1 (1) 5 (<1) 4 (<1) 2 (<1) 2 (<1) 0 (0) 0 (0) 33 (1)

110 year 5 surveys not included in the table

IRB requirements

The PRO protocol is a single-site CIBMTR protocol. All research activities, including enrollment and data collection, are centrally performed within the CIBMTR. Centers do not need to submit the PRO protocol or consent form to their local IRB for their patients to participate.

CIBMTR approved protocol and consent forms

The CIBMTR, through the NMDP IRB, has approved the following protocol and consent form. These are provided for reference only. Centers should not submit these materials for local IRB approval. Centers should not use these materials to consent recipients.

PRO Protocol

PRO IRB approvals

PRO consent forms

Protocol team contacts