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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02419469
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 17, 2015
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Precursor-B Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Lymphoma Drug: Cytarabine Drug: Daunorubicin Drug: Vincristine Drug: Prednisone Drug: PEG asparaginase Drug: Ofatumumab Drug: Rituximab Drug: Methotrexate Drug: Cyclophosphamide Drug: Mercaptopurine Drug: Doxorubicin Drug: Dexamethasone acetate Drug: Thioguanine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017


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

Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride

Drug: Daunorubicin
Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.
Other Names:
  • Daunorubicin Hydrochloride
  • Cerubidine
  • Daunomycin
  • DNR

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.

Other Names:
  • Pegaspargase
  • Oncaspar
  • Polyethylene Glycol Conjugated Lasparaginase-H

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.

Other Name: Arzerra

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.

Other Name: Rituxan

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.

Other Names:
  • Cytoxan
  • Neosar

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.

Other Names:
  • 6-Mercaptopurine
  • Purinethol
  • 6-MP

Drug: Doxorubicin
Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

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.

Other Name: Decadron

Drug: Thioguanine
Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.
Other Name: 6-thioguanine




Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 3 years ]
    Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have precursor-B lymphoblastic leukemia or lymphoma.
  2. Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately.
  3. Age between 12 to 30 years old
  4. Patients with central nervous system (CNS) disease or testicular disease are eligible.
  5. Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
  6. Signed informed consent prior to the start of systemic therapy. In the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
  7. Echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
  8. Creatinine should be < 3 mg/dL bilirubin < 3 mg/dl unless due to disease
  9. Zubrod Performance status of <3
  10. Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately.
  11. Lymphoblasts may have any positive expression of cluster of differentiation antigen 20 (CD20) for ofatumumab administration.

Exclusion Criteria:

  1. Age less than twelve years of age or greater than 30 years.
  2. More than one prior treatment regimen for ALL or LL.
  3. The patient is pregnant or unwilling to practice appropriate birth control.
  4. Presence of the Philadelphia chromosome t(9;22)
  5. Laboratory or clinical evidence of active infectious hepatitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419469


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Jazz Pharmaceuticals
Investigators
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Principal Investigator: Michael E. Rytting, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02419469    
Other Study ID Numbers: 2014-0396
NCI-2015-00967 ( Registry Identifier: NCI CTRP )
First Posted: April 17, 2015    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Precursor-B acute lymphoblastic leukemia
ALL
Lymphoblastic lymphoma
LL
Lymphoma
Cytarabine
Ara-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride
Daunorubicin
Daunorubicin Hydrochloride
Cerubidine
Daunomycin
DNR
Vincristine
Prednisone
PEG asparaginase
Pegaspargase
Oncaspar
Polyethylene glycol conjugated lasparaginase-H
Ofatumumab
Arzerra
Rituximab
Rituxan
Methotrexate
Cyclophosphamide
Cytoxan
Neosar
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisone
Dexamethasone acetate
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Ofatumumab
Thioguanine
Pegaspargase
BB 1101
Immunosuppressive Agents
Immunologic Factors