Status:
COMPLETED
Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Study Drug Administration and Procedures: The chemotherapy, some of the other drugs in this study, and the stem cell transplant will be given by vein through your central venous catheter (CVC). A cen...
Eligibility Criteria
Inclusion
- 18 to 70 years of age.
- 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.
- 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.
- 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.
- Performance score of at least 80% by Karnofsky or 0 to 2 ECOG.
- Left ventricular EF \>/= 45% with no uncontrolled arrythmias or symptomatic heart disease.
- FEV1, FVC \>/= 60% and corrected DLCO \>/= 60%.
- Serum creatinine \</=1.6 mg/dL. Serum bilirubin \< 2 mg/dL (unless due to Gilbert's Syndrome).
- SGPT \< 2 X upper limit of normal.
- 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.
- 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
- Patient with active CNS involvement with lymphoid malignancy.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to study registration. Skin squamous or basal cell carcinoma are exceptions.
- Active bacterial, viral or fungal infections.
- History of stroke within 6 months prior to study registration.
- A prior allogeneic stem cell transplant.
- Patient has received other investigational drugs within 3 weeks before study registration.
- Presence of circulating malignant lymphoid cells or bone marrow with lymphoma that constituted more than 25% of the cellular elements.
- Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation.
- Patients who are breast-feeding.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01490723
Start Date
January 1 2013
End Date
April 24 2019
Last Update
May 5 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030