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Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia


Phase 2
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia


Study Drug:

Ofatumumab is designed to bind to the surface of a type of white blood cells. This may
cause cancer cells that come from these white blood cells to die.

Central Venous Catheter (CVC):

If you are found to be eligible to take part in this study, you will receive a CVC if you do
not already have one. A CVC is a sterile flexible tube that will be placed into a large
vein while you are under local anesthesia. Your doctor will explain this procedure to you
in more detail, and you will be required to sign a separate consent form for this procedure.

Study Plan:

During Cycles 1-8, you will receive ofatumumab during Cycles 1, 2, 3, and 4. During Cycles
1, 3, 5, and 7, you also will receive cyclophosphamide, vincristine, doxorubicin, and
dexamethasone (hyper-CVAD). During Cycles 2, 4, 6, and 8, you will also receive
methotrexate and cytarabine.

After Cycles 1-8, you will receive up to 30 cycles of Maintenance therapy.

During Maintenance:

- During Cycles 1-5, 8-17, and 20-30, you will receive 6-mercaptopurine, methotrexate,
vincristine, and prednisone.

- During Cycles 6 and 18 (or Cycles 7 and 19), you will receive cyclophosphamide,
vincristine, doxorubicin, dexamethasone, and ofatumumab.

- During Cycles 7 and 19 (or Cycles 6 and 18), you will receive methotrexate and
pegylated asparaginase.

First Phase of Treatment (Cycles 1-8):

Every 21 days is a study cycle.

You will receive ofatumumab by vein over 4-6 hours on Days 1 and 11 of Cycles 1 and 3 and on
Days 1 and 8 of Cycles 2 and 4.

During Cycles 1, 3, 5, and 7, you will also receive the following drugs:

- On Days 1-3, you will receive cyclophosphamide 2 times a day by vein over 3 hours.

- On Days 1-3, you will receive mesna by vein non-stop for the 3 days. The mesna
infusion will end about 12 hours after the last dose of cyclophosphamide.

- On Day 4, you will receive doxorubicin by vein non-stop for 1 day through the CVC.

- On Day 4, you will receive vincristine by vein over 15 minutes.

- On Days 1-4 and 11-14, you will receive dexamethasone 1 time a day by vein over 30
minutes or by mouth.

During Cycles 2, 4, 6, and 8, you will also receive the following drugs:

- On Day 1, you will receive methotrexate by vein over 24 hours. If your doctor thinks
it is needed to help reduce the risk of side effects, you may receive leucovorin by
vein 4 times a day for 8 doses, beginning 12 hours after the Day 1 methotrexate dose
ends.

- On Days 2 and 3, you will receive cytarabine by vein 2 times a day over 2 hours.

You may receive filgrastim or pegfilgrastim at the end of every cycle to help raise your
blood cell counts after you finish chemotherapy. If you receive filgrastim, it will be given
by a needle under your skin. If you receive pegfilgrastim, it will be given by a needle
under your skin.

You may be given other drugs to help prevent side effects. The study staff will tell you
about these drugs, how they will be given, and the possible risks.

If you are previously untreated for cancer, you will receive the following drugs during
Cycles 1-4 to help prevent disease in your brain and spinal fluid:

- On Day 2, you will receive methotrexate as an injection into the spinal canal (the
space surrounding the spinal cord).

- On Day 7, you will receive cytarabine as an injection into the spinal canal.

If you have mediastinal lymphoblastic lymphoma and bulky mediastinal disease or mediastinal
lymphadenopathy (enlarged lymph nodes in the chest area), you may have radiation therapy to
the chest area based on the status of the disease. The radiation therapy will be given after
you recover from Cycle 8 and before you start Maintenance therapy. Your doctor will explain
radiation therapy to you in more detail, and you will be required to sign a separate consent
form for this procedure.

Maintenance Therapy:

During Maintenance Cycles 1-5, 8-17, and 20-30:

- You will take 6-mercaptopurine by mouth 3 times daily.

- On Day 1, you will receive vincristine by vein over 15 minutes.

- You will take methotrexate by mouth weekly.

- On Days 1 and 5, you will take prednisone by mouth.

During Maintenance Cycles 6 and 18 (or Cycles 7 and 19), you will receive the same drugs on
the same schedule as you did during Cycles 1-8.

During Maintenance Cycles 7 and 19 (or Cycles 6 and 18):

- You will take methotrexate by mouth weekly.

- You will receive pegylated asparaginase on Day 2 by vein over 2 hours

If you have Burkitt Leukemia, you will only receive induction, consolidation and intrathecal
chemotherapy (injected into the spinal canal). You will not receive maintenance therapy.

Study Visits:

You will have a physical exam before each cycle.

One (1) time a week during Cycles 1-8, then 1 time a month during Maintenance, blood (about
2-3 teaspoons) will be drawn for routine tests.

On Day 14 of Cycle 1, then 1 time a week, you will have a bone marrow aspiration and/or
biopsy to check the status of the disease. If the cancer goes into remission (no sign of
disease) the bone marrow aspirations/biopsies will then be performed every 4 months.

You will have a chest x-ray or PET/CT scan anytime the doctor thinks it is needed.

Length of Study:

You may receive up to 38 cycles of study drugs. You will no longer be able to take the
study drugs if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.

Follow-Up:

You will be followed for side effects until 30 days after your last dose of study drugs.
You will have blood (about 2-3 teaspoons) drawn.

Long-Term Follow-Up:

The study staff will call you every 3 months for 1 year after you finish receiving the study
drugs. During the calls, you will be asked how are you feeling and about any side effects
you may have had and any drugs you may have taken.

This is an investigational study. Ofatumumab is FDA approved or commercially available for
the treatment of chronic lymphocytic leukemia. Its use to treat ALL is investigational.

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients of all ages with newly diagnosed, previously untreated CD-20+ ALL, or
lymphoblastic lymphoma, Burkitt Leukemia or having achieved CR with one course of
induction chemotherapy.

2. Failure to one induction course of chemotherapy (these patients will be analyzed
separately).

3. Performance status of 0, 1, or 2.

4. Adequate organ function with creatinine less than or equal to 3.0 mg/dL (unless
considered tumor related), bilirubin less than or equal to 3.0 mg/dL (unless
considered tumor related).

5. Adequate cardiac function defined as no history of arrhythmia, history of MI, or
abnormal EKG within 3 months prior to study enrollment. Cardiac function will be
assessed by history and physical examination

6. No active or co-existing malignancy(other than ALL or lymphoblastic lymphoma) with
life expectancy less than 12 months due to that malignancy.

Exclusion Criteria:

1. Pregnant or nursing women.

2. Known to be HIV+

3. Ph+ ALL

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Unable or unwilling to sign the consent form

6. Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per investigator assessment)

7. Treatment with any known non - marketed drug substance or experimental therapy within
5 terminal half lives (calculated by multiplying the reported terminal half life by
5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in
any other interventional clinical study.

8. History of significant cerebrovascular disease in the past 6 months or ongoing event
with active symptoms or sequelae

9. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In
addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB
DNA test will be performed and if positive the subject will be excluded.

10. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which
case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the
result

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-Free Survival (EFS)

Outcome Description:

Event-free survival measured from the start of therapy until failure to respond, relapse or death.

Outcome Time Frame:

Assessed beginning Day 14 of Cycle 1, on-going to disease progression (estimated 3+ years)

Safety Issue:

No

Principal Investigator

Elias Jabbour, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0708

NCT ID:

NCT01363128

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Acute Lymphoblastic Leukemia
  • CD-20 Positive Acute Lymphoblastic Leukemia
  • Any level of CD20 expression
  • Lymphoblastic lymphoma
  • Central Venous Catheter
  • CVC
  • HCVAD
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Mesna
  • Mesnex
  • Doxorubicin
  • Adriamycin
  • Rubex
  • Vincristine
  • Dexamethasone
  • Decadron
  • Ofatumumab
  • Arzerra
  • Methotrexate
  • Cytarabine
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030