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

Summary

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied.

Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

Conditions

• Leukemia
• Precursor-B Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma
• Lymphoma

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.

Sponsors & Collaborators

• Jazz Pharmaceuticals

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Michael E. Rytting, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-13

Primary Completion

2017-06-22

Completion

2017-06-22

FDA Drug

Yes

Countries

• United States

Study Locations