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Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System


Phase 1/Phase 2
3 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoid Malignancies, Metastatic Malignant Neoplasm to the Leptomeninges

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Trial Information

Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System


Study Groups and Study Drug Administration:

If you are found to be eligible, you will be assigned to a study group based on when you
join this study. Up to 12 participants will be enrolled in the Phase I portion of the
study, and up to 13 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of rituximab you receive will depend on
when you joined this study. The first group of participants will receive the lowest dose
level of rituximab. Each new group will receive a higher dose of rituximab than the group
before it, if no intolerable side effects were seen. This will continue until the highest
tolerable dose of rituximab is found.

If you are enrolled in the Phase II portion, you will receive rituximab at the highest dose
that was tolerated in the Phase I portion.

Study Visits:

Once enrolled, you will return to the clinic and receive the study drug by spinal tap up to
2 times a week. You will receive treatment twice a week until 2 Cerebrospinal fluid (CSF)
samples in a row do not show any leukemia cells. After that, you will receive treatment 1
time a week for an additional 4 weeks, and then you will receive treatment once every other
week for an additional 8 weeks. The number of doses you receive will depend on how many
doses the study doctor thinks is needed.

At each study visit the following procedures will be performed:

- You will have a physical exam, including measurement of your weight, and vital signs.
Your vital signs will be measured every 15 minutes for 1 hour after each dose of
rituximab.

- You will be asked how well you are able to perform the normal activities of daily
living (performance status).

- You will be asked about any drugs you may be taking and any side effects you may
experiencing.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- A sample of cerebral spinal fluid may be collected from the lumbar puncture to verify
the absence or presence of blast cells.

Follow-Up:

About 30 days after your last dose of study drug you will be contacted by the study staff by
telephone and asked about any drugs you may be taking and any side effects you may
experiencing. This call should take about 10 minutes.

Long-term Follow-up:

Every 6 to 12 months you may be contacted by the study staff by telephone and asked about
any drugs you may be taking and any side effects you may experiencing. This call should take
about 10 minutes.

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.

Length of Treatment:

The number of treatments you receive will depend on how long it takes for there to be no
leukemia cells in the CSF samples. Once this happens, you will have treatments for an
additional 12 weeks. You will no longer be able to take the study drug if the disease gets
worse, if intolerable side effects occur, or if you are unable to follow study directions.


Inclusion Criteria:



1. Patients must have relapsed or refractory CD20+ lymphoid malignancies with either
documented Central Nervous System (CNS) involvement or peripheral nerve infiltration.

2. Patients 3 years of age and older are eligible after 3 patients (age 15 or older)
have been treated and did not experience a dose limiting toxicity. Patient 3 to 15
years of age will follow the dose escalation schema independent of the adults.

3. ECOG performance status measure will be used. (Eastern Cooperative Oncology Group
(ECOG) Performance Status less than or equal to 3)

4. Adequate liver function (bilirubin less than or equal to 3 mg/dL within 24 hours of
enrollment)

5. Adequate renal function (serum creatinine less than or equal to 3 mg/dL within 24
hours of enrollment)

6. Urine pregnancy test for women of childbearing potential (defined as not
post-menopausal for 12 consecutive months or no previous surgical sterilizations). A
negative urine pregnancy test is required within 48 hours of initiating study drug.

7. Signed informed consent

Exclusion Criteria:

1. Known active meningeal infection

2. History of severe infusion reaction to any monoclonal antibody

3. Patients with prior neuraxis radiotherapy are excluded.

4. Patients are excluded for any prior history of whole-brain or cranio-spinal
irradiation or any current need for whole-brain or cranio-spinal irradiation. A need
for focused radiation therapy to a portion of the spine will not make patients
ineligible.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate

Outcome Description:

The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.

Outcome Time Frame:

Response assessed after minimum 2 weeks/4 treatments (2 twice weekly treatments)

Safety Issue:

No

Principal Investigator

Elias Jabbour, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-0844

NCT ID:

NCT01596127

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoid Malignancies
  • Metastatic Malignant Neoplasm to the Leptomeninges
  • relapsed CD20+ lymphoid malignancies
  • refractory CD20+ lymphoid malignancies
  • Rituximab
  • Intrathecal Rituximab
  • CNS
  • Leptomeningeal disease
  • LMD
  • central nervous system disease
  • Relapsed lymphoid malignancies
  • refractory lymphoid malignancies
  • CNS leukemia
  • intrathecal chemotherapy
  • cerebrospinal fluid
  • CSF
  • lumbar puncture
  • LP
  • Neoplasms
  • Leukemia
  • Meningeal Carcinomatosis
  • Neoplasms, Second Primary

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030