Overview

Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)

Status:
Completed
Trial end date:
2019-04-24
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied. Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body. Rituximab is designed to attach to lymphoma cells, which may cause them to die. Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Spectrum Pharmaceuticals, Inc
Treatments:
Antibodies, Monoclonal
Antilymphocyte Serum
Bendamustine Hydrochloride
Fludarabine
Fludarabine phosphate
Lenograstim
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Rituximab
Tacrolimus
Thymoglobulin
Vidarabine
Criteria
Inclusion Criteria:

1. 18 to 70 years of age.

2. Patients with the following CD20+ lymphoid malignancies who are eligible for
allogeneic transplantation: a. Relapsed or refractory follicular lymphoma; b. Relapsed
or refractory or high risk mantle cell lymphoma (hi ki67; blastic); c. Recurrent or
refractory marginal zone; d. Recurrent or refractory CLL/small lymphocytic lymphoma;
e. Double-hit lymphoma; f. Diffuse large B cell lymphoma; g. Richter's patients; or h.
Refractory or recurrent Burkitts.

3. Patients who meet criterion #2 or have any of the following are eligible: a. Less than
PR to salvage chemotherapy; b. Kinetic failure; c. Having received more than 3 lines
of therapy; d. Failure to mobilize autologous stem cell; e. 10% or more marrow
involvement; f. 6 months post autologous stem cell transplant.

4. Patients must have a fully-matched related donor or a matched unrelated donor
identified. Double cord (at least 4/6 matched) can be used if no adult matched donor
is available.

5. Performance score of at least 80% by Karnofsky or 0 to 2 ECOG.

6. Left ventricular EF >/= 45% with no uncontrolled arrythmias or symptomatic heart
disease.

7. FEV1, FVC >/= 60% and corrected DLCO >/= 60%.

8. Serum creatinine Syndrome).

9. SGPT < 2 X upper limit of normal.

10. Men and women of reproductive potential must agree to follow accepted birth control
methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with
spermicide, condom with spermicide, or abstinence) for the duration of the study.

11. Negative Beta HCG test within 30 days in a woman with child bearing potential defined
as not post-menopausal for 12 months or no previous surgical sterilization). Pregnancy
testing is not required for post-menopausal or surgically sterilized women.

Exclusion Criteria:

1. Patient with active CNS involvement with lymphoid malignancy.

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

3. Patients with other malignancies diagnosed within 2 years prior to study registration.
Skin squamous or basal cell carcinoma are exceptions.

4. Active bacterial, viral or fungal infections.

5. History of stroke within 6 months prior to study registration.

6. A prior allogeneic stem cell transplant.

7. Patient has received other investigational drugs within 3 weeks before study
registration.

8. Presence of circulating malignant lymphoid cells or bone marrow with lymphoma that
constituted more than 25% of the cellular elements.

9. Serious nonmalignant or malignant disease or psychiatric illness, which, in the
opinion of the investigator would compromise protocol objectives or interfere with
participation.

10. Patients who are breast-feeding.