NCT00626626 · OUTCOME

Disease-Free Survival

Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation · Source last updated 2018-04-25

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

Observe disease free survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)	5
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)	3

Reported measurements

Source class 1

Disease Free

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)	0	Not reported	Not reported	Not reported	Not reported
Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)	1	Not reported	Not reported	Not reported	Not reported

Relapsed

Values in Participants · Interval/dispersion: Not reported
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)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Disease Free
measurements
group Id
OG000
value
5
group Id
OG001
value
2
title
Relapsed

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
3
units
Participants

description

Observe disease free survivals in acute leukemia and lymphoma patients receiving allogeneic hematopoietic transplant after Clofarabine and cyclophosphamide conditioning.

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

Disease-Free Survival

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice