Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

November 13, 2015

Primary Completion Date

June 22, 2017

Study Completion Date

June 22, 2017

Conditions
LeukemiaPrecursor-B Acute Lymphoblastic LeukemiaLymphoblastic LymphomaLymphoma
Interventions
DRUG

Cytarabine

"Participants initially receive intrathecal treatment using Cytarabine 100 mg on Day 1. Induction chemotherapy must begin within 3 days of the intrathecal Cytarabine dose.~Consolidation Therapy 1: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and 8 - 11.~Consolidation Therapy 3B: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and Days 8 - 11."

DRUG

Daunorubicin

Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.

DRUG

Vincristine

"Induction Therapy: Vincristine 1.5 mg/m2 by vein weekly for 4 doses.~Consolidation Therapy 1: Vincristine 1.5 mg/m2 by vein Week 3 and Week 4.~Consolidation Therapy 2: Vincristine 1.5 mg/m2 by vein every 10 days for 5 doses.~Consolidation Therapy 3A: Vincristine 1.5 mg/m2 by vein weekly for 3 doses.~Consolidation Therapy 3B: Vincristine 1.5 mg/m2 by vein Weeks 3 and 4.~Maintenance Therapy (24 months): Vincristine 1.5 mg/m2 by vein every 28 days."

DRUG

Prednisone

Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.

DRUG

PEG asparaginase

"Induction Therapy: PEG asparaginase 2000 IU/m2 by vein on Day 4 of induction.~Consolidation Therapy 1: PEG-asparaginase 2000 IU/m2 by vein Week 3 and Week 7.~Consolidation Therapy 2: PEG-asparaginase 2000 IU/m2 by vein Weeks 1 and 4.~Consolidation Therapy 3A: PEG-asparaginase 2000 IU/m2 by vein in Week 1.~Consolidation Therapy 3B: PEG-asparaginase 2000 IU/m2 by vein Week 3."

DRUG

Ofatumumab

"Induction Therapy: Ofatumumab 300 mg by injection or vein on Day 2 and Ofatumumab 2000 mg by injection or vein on Day 15.~Consolidation Therapy 1: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.~Consolidation Therapy 2: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.~Consolidation Therapy 3A: Ofatumumab 2000 mg by injection or vein Week 1 and Week 3."

DRUG

Rituximab

"Induction Therapy: If Ofatumumab not available, Rituximab 375 mg/m2 by vein on Day 1 and on Day 15.~Consolidation Therapy 1: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.~Consolidation Therapy 2: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.~Consolidation Therapy 3A: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 3."

DRUG

Methotrexate

"Induction Therapy: Intrathecal methotrexate 12 mg on Day 8 and Day 29.~Consolidation Therapy 1: Intrathecal methotrexate 12 mg Weekly, Weeks 1 - 4.~Consolidation Therapy 2: Methotrexate by vein every 10 days starting at 100 mg/m2 and increasing by 50 mg/m2 as tolerated. and Intrathecal methotrexate 12 mg Week 1.~Consolidation Therapy 3A: Intrathecal methotrexate 12 mg in Week 1.~Consolidation Therapy 3B: Intrathecal methotrexate 12 mg Week 1 and 2.~Maintenance Therapy (24 months): Methotrexate 20 mg/m2 by mouth weekly, hold on days of intrathecal methotrexate.~Maintenance Therapy (24 months): Intrathecal methotrexate 12 mg every 3 months for 4 doses."

DRUG

Cyclophosphamide

"Consolidation Therapy 1: Cyclophosphamide 1 gram/m2 by vein Week 1 and Week 5.~Consolidation Therapy 3B: Cyclophosphamide 1 gram/m2 by vein Week 1."

DRUG

Mercaptopurine

"Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14.~Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly."

DRUG

Doxorubicin

Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.

DRUG

Dexamethasone acetate

"Consolidation Therapy 3A: Dexamethasone 10 mg/m2 by mouth on Days 1 - 7 and Days 15 - 21.~Maintenance Therapy (24 months): Dexamethasone 6 mg/m2/day by mouth Days 1 - 5 every 28 days."

DRUG

Thioguanine

Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER