Trial Outcomes & Findings for Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation (NCT NCT00626626)
NCT ID: NCT00626626
Last Updated: 2018-04-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
two years
Results posted on
2018-04-25
Participant Flow
Participant milestones
| Measure |
"Clofar, Cyclophos, Alemtuzumab"
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.
|
"Clofar, Cyclophos,Alemtuzumab(Ph 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)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation
Baseline characteristics by cohort
| Measure |
Dose Level1
n=5 Participants
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.
|
Dose Level 2
n=3 Participants
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)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two yearsEstablish 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.
Outcome measures
| Measure |
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )
n=5 Participants
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)
n=3 Participants
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)
|
|---|---|---|
|
Engraftment of Allogeneic Blood Cells.
Safety
|
5 Participants
|
3 Participants
|
|
Engraftment of Allogeneic Blood Cells.
Adequate Engraftment
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Two yearsObserve disease free survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning.
Outcome measures
| Measure |
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )
n=5 Participants
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)
n=3 Participants
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)
|
|---|---|---|
|
Disease-Free Survival
Disease Free
|
0 Participants
|
1 Participants
|
|
Disease-Free Survival
Relapsed
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsObserve overall survival in leukemia and lymphoma patients receiving transplant after clofarabine and cyclophosphamide conditioning.
Outcome measures
| Measure |
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )
n=5 Participants
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)
n=3 Participants
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)
|
|---|---|---|
|
Overall Survival
Survival (2 years)
|
1 Participants
|
1 Participants
|
|
Overall Survival
Lost to Followup
|
1 Participants
|
0 Participants
|
|
Overall Survival
Died
|
3 Participants
|
2 Participants
|
Adverse Events
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)
n=5 participants at risk
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)
n=3 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Failure to engraft
|
80.0%
4/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)
n=5 participants at risk
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)
n=3 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Decreased Leukocytes
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
3/5 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Decreased ANC
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
5/5 • Number of events 7
|
100.0%
3/3 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Skin (due to shingles)
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
20.0%
1/5 • Number of events 6
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Creatinine
|
40.0%
2/5 • Number of events 9
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60