NCT00245037 · OUTCOME
Regimen-Related Toxicities
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2017-09-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Toxicities
- Interval / dispersion
- Not reported
- Time frame
- 5 years post-transplant
What was measured
Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
Groups in this outcome
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 147 |
|---|
Reported measurements
Cardiac Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Renal Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Respiratory Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
CNS Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Hepatic Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
General Disorders
Values in Toxicities · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Cardiac Disorders
- title
- Renal Disorders
- title
- Respiratory Disorders
- title
- CNS Disorders
- title
- Hepatic Disorders
- title
- General Disorders
- description
- Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
- groups
- description
- Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.
Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.
IV Busulfan is available and diluted and administered per package insert guidelines.
Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
- id
- OG000
- title
- Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 5 years post-transplant
- title
- Regimen-Related Toxicities
- type
- PRIMARY
- unit Of Measure
- Toxicities
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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