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Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

Thank you

Trial Information

Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies


The Study Drugs:

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may
increase the likelihood of the cells dying.

Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.

Study Drug Administration and Stem Cell Transplant:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of bendamustine based on when you joined this study. The first group of participants
will receive the lowest dose level. Each new group will receive a higher dose than the
group before it, if no intolerable side effects were seen. This will continue for up to 4
dose levels, until the highest tolerable dose of bendamustine is found.

You will begin receiving the study drugs within 30 days after the screening visit. All of
the study drugs will be given through a central venous catheter (CVC) that will be left in
place the entire time that you are receiving study drugs. 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.

On Day -13 (13 days before you receive the stem cell transplant) and then 1 time each week
for 4 weeks, you will receive rituximab over 5-7 hours through the CVC. If you have T-cell
lymphoma, you will not receive rituximab.

On Days -5 to -3, you will receive fludarabine and bendamustine over 1 hour each day through
the CVC. During this time, you will also receive hydrocortisone and tacrolimus through the
CVC to help prevent or ease side effects (such as chills, rash, and/or hives).

On Day -2, you will start to receive tacrolimus by CVC to help prevent graft-versus-host
disease. This will be changed to a dose of tacrolimus by mouth, once you are discharged
from the hospital. You will continue to take tacrolimus by mouth for 6-8 months following
your transplant.

On Days -2 and -1, if your stems cells are from a matched unrelated donor, you will receive
thymoglobulin.

On Day 0, you will receive the donor blood stem cells through the CVC over 30-45 minutes.

On Days 1, 3, and 6 (after the stem cell transplant), you will receive methotrexate over 30
minutes each day through the CVC to help prevent graft-versus-host-disease. Patients
receiving a matched unrelated donor will also be given methotrexate on day 11 after the
transplant.

Beginning on Day 7, you will receive filgrastim (G-CSF) through a needle under your skin 1
time each day until your white blood cell counts recover.

Study Visits:

You must stay in the Houston area for about 100 days after the stem cell transplant.

You will be in the hospital for up to about 3-4 weeks after you receive the stem cell
transplant. During this time, the following tests and procedures will be performed:

- Blood (about 3 teaspoons) will be collected for routine tests 1 time each day.

- When your doctor thinks it is needed, you will have imaging scans (such as the ones
performed during the screening visit) to check the status of the disease and/or for
possible infections.

- When your doctor thinks it is needed, you will have transfusions of blood and/or
platelets.

- When your doctor thinks it is needed, you will have a bone marrow biopsy to check the
status of the disease.

Between Days 25 and 35 after the stem cell transplant, the following tests and procedures
will be performed:

- You will have CT scans to check the status of the disease.

- Blood (about 6 teaspoons) will be drawn for routine tests.

- You will have a bone marrow biopsy/aspirate to check the status of the disease.

- If your doctor thinks it is needed, you will have a PET scan to check the status of the
disease.

Long-Term Follow-Up:

Every 3 months after the stem cell transplant during the first year and then every 6 months
for up to 3 years, the following tests and procedures will be performed:

- You will have CT scans to check the status of the disease.

- Blood (about 6 teaspoons) will be drawn for routine tests.

- You will have a bone marrow biopsy/aspirate to check the status of the disease.

- If your doctor thinks it is needed, you will have a PET scan to check the status of the
disease.

Length of Study:

You will be on study for up to about 3 years. You will be taken off study if the disease
gets worse or you experience any intolerable side effects.

End-of-Study Visit:

After you are off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:

- You will have CT scans to check the status of the disease.

- Blood (about 6 teaspoons) will be drawn for routine tests.

- You will have a bone marrow biopsy/aspirate to check the status of the disease.

- If your doctor thinks it is needed, you will have a PET scan to check the status of the
disease.

This is an investigational study. Rituximab and fludarabine are FDA approved and
commercially available for the treatment of lymphoma. Fludarabine and bendamustine are FDA
approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL)
. The use of bendamustine in combination with the other study drugs and a stem cell
transplant for the treatment of lymphoma and leukemia is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. 18 to 70 years of age.

2. Patients with CD20 + CLL, marginal zone, mantle cell and follicular lymphoma or
T-cell lymphoid malignancies who are eligible for allogeneic transplantation.

3. Patients with relapsed diffuse large B-cell lymphoma may be included if there were
not eligible for autologous transplantation.

4. A fully-matched sibling donor or matched unrelated donor.

5. Left ventricular EF > 40% with no uncontrolled arrythmias or symptomatic heart
disease.

6. FEV1, FVC and DLCO > 40%.

7. Serum creatinine < 1.6 mg/dL. Serum bilirubin < 3X upper limit of normal.

8. SGPT < 3X upper limit of normal.

9. Voluntary signed, written IRB-approved informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
medical care.

10. Men and women of reproductive potential must agree to follow accepted birth control
methods for the duration of the study. Female subject is either post-menopausal or
surgically sterilized or willing to use an acceptable method of birth control (i.e.,
a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom
with spermicide, or abstinence) for the duration of the study. Male subject agrees to
use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

1. Patient with active CNS disease.

2. Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as
not post-menopausal for 12 months or no previous surgical sterilization) or currently
breast-feeding. Pregnancy testing is not required for post-menopausal or surgically
sterilized women.

3. Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.

4. Patients with other malignancies diagnosed within 2 years prior to Study Day-13
(except skin squamous or basal cell carcinoma).

5. Active uncontrolled bacterial, viral or fungal infections.

6. History of Stroke within 6 months.

7. Myocardial infarction within the past 6 months prior to Study Day 1, or has New York
Heart Association (NYHA) Class III or IV heart failure or arrythmias, unstable
angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic
evidence of acute ischemia or active conduction system abnormalities. Prior to study
entry, any ECG abnormality at screening must be documented by investigator as not
medically relevant.

8. A prior allogeneic transplant.

9. Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

10. Patient has received other investigational drugs within 3 weeks before enrollment.

11. Hypersensitivity to bendamustine.

12. Prior known refractoriness to bendamustine.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) of Bendamustine

Outcome Time Frame:

Continual reassessment during first 30 days for dose limiting toxicity (DLT)

Safety Issue:

Yes

Principal Investigator

Issa F. Khouri, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0246

NCT ID:

NCT00880815

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoid Malignancies
  • Non-myeloablative Allogeneic Conditioning
  • Non-myeloablative Allogeneic Hematopoietic Transplantation
  • Stem Cell Transplant
  • SCT
  • Bendamustine HCI
  • Bendamustine
  • Bendamustine Hydrochloride
  • CEP-18083
  • SDX-105
  • Treanda
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Rituximab
  • Rituxan
  • FBR
  • Graft-versus-host disease
  • GVHD
  • Neoplasms
  • Leukemia
  • Lymphoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030