When a recipient receives a genetically modified cell therapy product after HCT, there is a need to continue to capture both HCT and CT outcomes. As of the Summer 2020 release, CIBMTR implemented new functionality to reduce center reporting burden and redundancies when having to report multiple cell therapy and HCT events for a single patient. This process is known as “combined follow-up”.
All applicable follow-up forms will be aligned under the same event date at the appropriate timepoints (i.e. Forms 2450+4100 or 2100+4100). Custom enabling and disabling of duplicate questions will streamline follow-up reporting when a recipient receives infusions for multiple indications with overlapping time periods.
If a recipient receives a genetically modified cell therapy infusion and then receives an HCT, all future events will have combined follow-up rules applied as applicable.
Refer to the elearning Combined Follow-Up: HCT and Cellular Therapy for more detailed information on reporting rules.
Scenario 1: HCT (TED) -> Cell Therapy (TED)
F4100 + F2450 associated with the cell therapy date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2450 |
|---|---|---|
| Survival | Enabled, must match with corresponding F2450 | Enabled, must match with corresponding F4100 |
| Subsequent infusions | Disabled | Enabled |
| Best response to cell therapy | Enabled | n/a |
| Peripheral blood count recovery / Initial ANC and platelet recovery | Enabled | Disabled |
| Disease relapse or progression | Enabled for malignant diseases | n/a |
| New malignancy | Enabled | Disabled |
| GVHD | Disabled | Enabled for allogeneic infusions |
| Liver toxicity prophylaxis | n/a | Enabled |
| VOD / SOS | n/a | Disabled |
| Toxicities | Enabled | n/a |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Disease assessment at the time of best response | n/a | Disabled |
| First relapse or progression post-infusion | n/a | Disabled |
| Recurrence of non-malignant disease | n/a | Enabled for non-malignant diseases |
| Post-infusion intervention for disease | n/a | Disabled |
| Post-infusion treatment given to prevent relapse or progression | n/a | Disabled |
| Fecal microbiota transplant (FMT) | n/a | Enabled |
| Infection | Enabled | n/a |
| Pregnancy status | Enabled | n/a |
| Current disease status | n/a | Disabled |
Scenario 2: HCT (TED) -> Cell Therapy (CRF)
F4100 / F4101 + F2450 associated with the cell therapy date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2450 |
|---|---|---|
| Survival | Enabled, must match with corresponding F2450 | Enabled, must match with corresponding F4100 |
| Subsequent infusions | Disabled | Enabled |
| Best response to cell therapy | Reported on disease form (if applicable) | n/a |
| Peripheral blood count recovery / Initial ANC and platelet recovery | Enabled | Disabled |
| Disease relapse or progression | Reported on disease form (if applicable) | n/a |
| New malignancy | Enabled | Disabled |
| GVHD | Disabled | Enabled for allogeneic infusions |
| Liver toxicity prophylaxis | n/a | Enabled |
| VOD / SOS | n/a | Disabled |
| Toxicities | Enabled | n/a |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Disease assessment at the time of best response | n/a | Disabled |
| First relapse or progression post-infusion | n/a | Disabled |
| Recurrence of non-malignant disease | n/a | Enabled for non-malignant diseases |
| Post-infusion intervention for disease | n/a | Disabled |
| Post-infusion treatment given to prevent relapse or progression | n/a | Disabled |
| Fecal microbiota transplant (FMT) | n/a | Enabled |
| Infection | Enabled | n/a |
| Pregnancy status | Enabled | n/a |
| Current disease status | n/a | Disabled |
Scenario 3: HCT (CRF) -> Cell Therapy (TED)
F4100 + F2100 associated with the cell therapy date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2100 |
|---|---|---|
| Survival / Vital status | Enabled, must match with corresponding F2100 | Enabled, must match with corresponding F4100 |
| Subsequent infusions / Vital status | Disabled | Enabled |
| Best response to cellular therapy | Enabled | n/a |
| Peripheral blood count recovery / Granulopoiesis/Neutrophil recovery / Megakaryopoiesis/Platelet recovery | Enabled | Disabled |
| Disease relapse or progression | Enabled | n/a |
| New malignancy | Enabled | Disabled |
| Growth factor and cytokine therapy | n/a | Enabled |
| Current hematologic findings | n/a | Enabled |
| Immune reconstitution | n/a | Enabled |
| Gene therapy persistence testing | n/a | Enabled only for gene therapy infusions |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Engraftment syndrome | n/a | Disabled |
| GVHD / acute GVHD / chronic GVHD | Disabled | Enabled for allogeneic infusions |
| Toxicities | Enabled | n/a |
| Infection prophylaxis | n/a | Enabled |
| Infection | Enabled | Disabled |
| Organ function | n/a | Enabled |
| Pregnancy status | Enabled | Disabled |
Scenario 4: HCT (CRF) -> Cell Therapy (CRF)
F4100 / F4101 + F2100 associated with the cell therapy date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2100 |
|---|---|---|
| Survival / Vital status | Enabled, must match with corresponding F2100 | Enabled , must match with corresponding F4100 |
| Subsequent infusions / Vital status | Disabled | Enabled |
| Best response to cellular therapy | Reported on disease form (if applicable) | n/a |
| Peripheral blood count recovery / Granulopoiesis/Neutrophil recovery / Megakaryopoiesis/Platelet recovery | Enabled | Disabled |
| Disease relapse or progression | Reported on disease form (if applicable) | n/a |
| New malignancy | Enabled | Disabled |
| Growth factor and cytokine therapy | n/a | Enabled |
| Current hematologic findings | n/a | Disabled |
| Immune reconstitution | n/a | Enabled |
| Gene therapy persistence testing | n/a | Enabled only for gene therapy infusions |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Engraftment syndrome | n/a | Disabled |
| GVHD / acute GVHD / chronic GVHD | Disabled | Enabled for allogeneic infusions |
| Toxicities | Enabled | n/a |
| Infection prophylaxis | n/a | Enabled |
| Infection | Enabled | Disabled |
| Organ function | n/a | Enabled |
| Pregnancy status | Enabled | Disabled |
Scenario 5: Cell Therapy (TED) -> HCT (TED)
F4100 / F4101 + F2100 associated with the HCT date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2450 |
|---|---|---|
| Survival | Enabled, must match with corresponding F2450 | Enabled, must match with corresponding F4100 |
| Subsequent infusions | Disabled | Enabled |
| Best response to cell therapy | Disabled | n/a |
| Peripheral blood count recovery / Initial ANC and platelet recovery | Disabled | Enabled |
| Disease relapse or progression | Disabled | n/a |
| New malignancy | Enabled | Disabled |
| GVHD | Disabled | Enabled for allogeneic infusions |
| Liver toxicity prophylaxis | n/a | Enabled |
| VOD / SOS | n/a | Enabled |
| Toxicities | Enabled | n/a |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Disease assessment at the time of best response | n/a | Enabled |
| First relapse or progression post-infusion | n/a | Enabled |
| Recurrence of non-malignant disease | n/a | Enabled for non-malignant diseases |
| Post-infusion intervention for disease | n/a | Enabled for malignant diseases |
| Post-infusion treatment given to prevent relapse or progression | n/a | Enabled for malignant diseases |
| Fecal microbiota transplant (FMT) | n/a | Enabled |
| Infection | Enabled | n/a |
| Pregnancy status | Enabled | n/a |
| Current disease status | n/a | Enabled |
Scenario 6: Cell Therapy (TED) -> HCT (CRF)
F4100 / F4101 + F2100 associated with the HCT date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2100 |
|---|---|---|
| Survival / Vital status | Enabled, must match with corresponding F2100 | Enabled , must match with corresponding F4100 |
| Subsequent infusions / Vital status | Disabled | Enabled |
| Best response to cellular therapy | Reported on disease form (if applicable) | n/a |
| Peripheral blood count recovery / Granulopoiesis/Neutrophil recovery / Megakaryopoiesis/Platelet recovery | Disabled | Enabled |
| Disease relapse or progression | Reported on disease form (if applicable) | n/a |
| New malignancy | Enabled | Disabled |
| Growth factor and cytokine therapy | n/a | Enabled |
| Current hematologic findings | n/a | Enabled |
| Immune reconstitution | n/a | Enabled |
| Gene therapy persistence testing | n/a | Enabled only for gene therapy infusions |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Engraftment syndrome | n/a | Enabled |
| GVHD / acute GVHD / chronic GVHD | Disabled | Enabled for allogeneic infusions |
| Toxicities | Enabled | n/a |
| Infection prophylaxis | n/a | Enabled |
| Infection | Enabled | Disabled |
| Organ function | n/a | Enabled |
| Pregnancy status | Enabled | Disabled |
Scenario 7: Cell Therapy (CRF) -> HCT (TED)
F4100 / F4101 + F2100 associated with the HCT date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2450 |
|---|---|---|
| Survival | Enabled, must match with corresponding F2450 | Enabled , must match with corresponding F4100 |
| Subsequent infusions | Disabled | Enabled |
| Best response to cell therapy | Disabled | n/a |
| Peripheral blood count recovery / Initial ANC and platelet recovery | Disabled | Enabled |
| Disease relapse or progression | Disabled | n/a |
| New malignancy | Enabled | Disabled |
| GVHD | Disabled | Enabled for allogeneic infusions |
| Liver toxicity prophylaxis | n/a | Enabled |
| VOD / SOS | n/a | Enabled |
| Toxicities | Enabled | n/a |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Disease assessment at the time of best response | n/a | Enabled |
| First relapse or progression post-infusion | n/a | Enabled |
| Recurrence of non-malignant disease | n/a | Enabled for non-malignant diseases |
| Post-infusion intervention for disease | n/a | Enabled for malignant diseases |
| Post-infusion treatment given to prevent relapse or progression | n/a | Enabled for malignant diseases |
| Fecal microbiota transplant (FMT) | n/a | Enabled |
| Infection | Enabled | n/a |
| Pregnancy status | Enabled | n/a |
| Current disease status | n/a | Enabled |
Scenario 8: Cell Therapy (CRF) -> HCT (CRF)
F4100 / F4101 + F2100 associated with the HCT date. Questions disabled on HCT and CT Forms:
| Section | F4100 | F2100 |
|---|---|---|
| Survival / Vital status | Enabled, must match with corresponding F2100 | Enabled, must match with corresponding F4100 |
| Subsequent infusions / Vital status | Disabled | Enabled |
| Best response to cellular therapy | Reported on disease form (if applicable) | n/a |
| Peripheral blood count recovery / Granulopoiesis/Neutrophil recovery / Megakaryopoiesis/Platelet recovery | Disabled | Enabled |
| Disease relapse or progression | Reported on disease form (if applicable) | n/a |
| New malignancy | Enabled | Disabled |
| Growth factor and cytokine therapy | n/a | Enabled |
| Current hematologic findings | n/a *Reported on F4101 | Disabled |
| Immune reconstitution | n/a | Enabled |
| Gene therapy persistence testing | n/a | Enabled only for gene therapy infusions |
| Chimerism studies | n/a | Enabled for non-malignant diseases and CBUs |
| Engraftment syndrome | n/a | Disabled |
| GVHD / acute GVHD / chronic GVHD | Enabled | Disabled |
| Toxicities | Enabled | n/a |
| Infection prophylaxis | n/a | Enabled |
| Infection | Enabled | Disabled |
| Organ function | n/a | Enabled |
| Pregnancy status | Enabled | Disabled |

