Lymphoma Clinical Trial
Official title:
Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies
Verified date | April 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 24, 2019 |
Est. primary completion date | April 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 </=1.6 mg/dL. Serum bilirubin < 2 mg/dL (unless due to Gilbert's 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Spectrum Pharmaceuticals, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-Related Mortality (TRM) | Number of participants without treatment related mortality at day 100. | 100 days | |
Secondary | Overall Survival (OS) | Percentage of participants alive at 3 years. | From date of treatment to date of relapse or death, up to 3 years |
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