NCT00061945 · FLOW

Participant flow

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia · Source last updated 2022-05-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 \& 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 \& 29, MTX IV \& IT d1,15 \& 19, MTX PO q6 hr d1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 \& 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
id
FG000
title
Phase I - Alemtuzumab and Combination Chemotherapy
description
COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 \& 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 \& 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 \& 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG \& FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 \& 29, MTX IV \& IT d 1,15 \& 19, MTX PO q6 hr d 1-2,15-16 \& 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 \& 30, LCV PO q6 hr d 3-4 \& CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 \& 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
id
FG001
title
Phase II - Alemtuzumab and Combination Chemotherapy

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
25
type
Not Alemtuzumab Eligible
reasons
group Id
FG000
num Subjects
76
group Id
FG001
num Subjects
90
type
Early discontinuation during course I-IV
milestones
achievements
group Id
FG000
num Subjects
119
group Id
FG001
num Subjects
181
type
STARTED
achievements
group Id
FG000
num Subjects
25
group Id
FG001
num Subjects
66
type
COMPLETED
achievements
group Id
FG000
num Subjects
94
group Id
FG001
num Subjects
115
type
NOT COMPLETED
title
Registration Through Course 3
drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
1
type
Declined Alemtuzumab
reasons
group Id
FG000
num Subjects
6
group Id
FG001
num Subjects
15
type
Early exits
milestones
achievements
group Id
FG000
num Subjects
25
group Id
FG001
num Subjects
66
type
STARTED
achievements
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
50
type
COMPLETED
achievements
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
16
type
NOT COMPLETED
title
Course IV: Alemtuzumab

pre Assignment Details

Two (2) participants cancelled prior to receiving any treatment and were removed from all analyses.

recruitment Details

From June 2003 to May 2007, a total of 302 participants were recruited.

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