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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02419469
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    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.
  • Daunorubicin — DRUG
    Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.
  • Vincristine — DRUG
    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.
  • Prednisone — DRUG
    Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.
  • PEG asparaginase — DRUG
    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.
  • Ofatumumab — DRUG
    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.
  • Rituximab — DRUG
    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.
  • Methotrexate — DRUG
    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.
  • Cyclophosphamide — DRUG
    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.
  • Mercaptopurine — DRUG
    Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14. Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly.
  • Doxorubicin — DRUG
    Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.
  • Dexamethasone acetate — DRUG
    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.
  • Thioguanine — DRUG
    Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.

Study Details

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.

Key Dates

Start date
Nov 13, 2015
Status verified
May 2018
Primary completion
Jun 22, 2017
Completion
Jun 22, 2017

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Augmented BFM Therapy + Ofatumumab or Rituximab
    Participants receive the study drugs in Induction, Consolidation, and Maintenance Courses.

Primary Outcome Measure

Event Free Survival (EFS) [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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