TriangleNCT00626626 · OUTCOME
Engraftment of Allogeneic Blood Cells.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- two years
What was measured
Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment. Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment. Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity.
Groups in this outcome
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )
Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy. Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)
Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide. Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
| Group | Source count |
|---|---|
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I ) | 5 |
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II) | 3 |
Reported measurements
Adequate Engraftment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I ) | 2 | Not reported | Not reported | Not reported | Not reported |
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II) | 1 | Not reported | Not reported | Not reported | Not reported |
Safety
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I ) | 5 | Not reported | Not reported | Not reported | Not reported |
| Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Adequate Engraftment
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Safety
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Establish the safety of Clofarabine and cyclophosphamide preceding allogeneic hematopoietic engraftment. Assess the efficacy of Clofarabine and cyclophosphamide as conditioning for promoting allogeneic hematopoietic engraftment. Adequacy of engraftment will be assessed via assessment of chimerism (percent donor engraftment). Less than 20% engraftment by day 30 is then failure of engraftment. Safety is defined per common toxicity criteria - Non-Hematological and non renal toxicities of ≥grade 3 or ≥grade 4 up to day 30 are scored as toxicity.
- groups
- description
- Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy. Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion.
- id
- OG000
- title
- Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )
- description
- Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide. Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)
- id
- OG001
- title
- Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- two years
- title
- Engraftment of Allogeneic Blood Cells.
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice