ALL Adult Consortium Trial: Adult ALL Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

September 30, 2013

Study Completion Date

March 31, 2020

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Doxorubicin

Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.

DRUG

Cytarabine

Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks

DRUG

Methotrexate

"Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).~Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks."

DRUG

Vincristine

Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.

DRUG

Cyclophosphamide

Consolidation IB: Intravenously on day 1

DRUG

Methylprednisone

Prophase: Intravenously on days 1-3

DRUG

Hydrocortisone Sodium Succinate

Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.

DRUG

Dexamethasone

Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.

DRUG

6-MP

Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.

DRUG

PEG-Asparaginase

"Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.~Consolidation II: Intravenously every 3 weeks."

DRUG

Imatinib

Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.

DRUG

Etoposide

Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.

PROCEDURE

Radiation Therapy

Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF

DRUG

E. coli Asparaginase

Intramuscularly Day 7 of Induction.

Trial Locations (15)

10032

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York

43210

Ohio State University Medical Center, Columbus

84143

LDS Hospital, Salt Lake City

02114

Massachusetts General Hospital, Boston

02115

Children's Hospital of Boston, Boston

02215

Beth Isreal Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

V5Z 4E6

Vancouver Cancer Center, Vancouver

R3E 0V9

Cancer Care Manitoba, Winnipeg

Unknown

The Moncton Hospital, Moncton

Hopital Notre-Dame, Montreal

McGill University Department of Oncology, Montreal

B3H 2Y9

QEII, Health Sciences Centre, Halifax

J4V 2H1

Hopital Charles LeMoyne, Greenfield Park

H1T 2M4

Hopital Maisonneuve Rosemont, Montreal

Sponsors
All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

collaborator

Boston Children's Hospital

OTHER

collaborator

NCIC Clinical Trials Group

NETWORK

lead

Dana-Farber Cancer Institute

OTHER