Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation
2 other identifiers
interventional
30
1 country
1
Brief Summary
The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more effective than the combination of BEAM and rituximab alone in patients with lymphoma who receive a stem cell transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2007
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedResults Posted
Study results publicly available
February 2, 2021
CompletedFebruary 2, 2021
January 1, 2021
12.3 years
December 27, 2007
January 12, 2021
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With a 2-Year Progression-Free Survival (PFS)
Response evaluated using the standard criteria response for lymphoma through CT scan.
2 years (beginning day 30 after treatment)
Study Arms (4)
Zevalin + BEAM + Rituximab +Stem Cell Transplant + Rituximab
ACTIVE COMPARATORZevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Zevalin + BEAM + Rituximab +Stem Cell Transplant
ACTIVE COMPARATORZevalin + BEAM + Rituximab Followed by Stem Cell Transplant
BEAM + Rituximab + Stem Cell Transplant + Rituximab
ACTIVE COMPARATORBEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
BEAM + Rituximab + Stem Cell Transplant
ACTIVE COMPARATORBEAM + Rituximab Followed by Stem Cell Transplant
Interventions
(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
300 mg/m\^2 by vein.
200 mg/m\^2 by vein every 12 hours.
200 mg/m\^2 by vein every 12 hours.
140 mg/m\^2 by vein.
Arm 1, Arm 2 = 250 mg/m\^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m\^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy.
Injection of stem cells (Autologous SCT)
Eligibility Criteria
You may qualify if:
- Relapsed CD20-positive B-cell diffuse large cell lymphoma (demonstrated in lymph nodes or bone marrow), chemosensitive (at least PR).
- Age: up to 18-70 years of age.
- Prestudy performance status of 0, 1, or 2 according to the WHO.
- No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. No prior rituximab within three weeks of starting therapy.
- If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
- Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count ({segmented neutrophils + bands} x total WBC) \> 1,500/mm³ and platelet counts \> 80,000/mm³
- IRB -approved signed informed consent.
- Patients determined to have \<10% bone marrow involvement with lymphoma within 60 days before study entry as defined by bone marrow aspirates and biopsies.
- Female patients included must not be pregnant or lactating.
- Patients should have at least 4-6 x 10\^6 CD34+/kg peripheral stem cells collected. Around 1-2 million cells will beheld as back up.
- 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.
- 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.
You may not qualify if:
- Failed stem cell collection of \>/= 4x10\^6CD34+/kg.
- Prior radioimmunotherapy.
- Presence of active CNS lymphoma.
- Patients with abnormal liver function: total bilirubin \> 1.5 mg/dl.
- Patients with abnormal renal function: serum creatinine \> 1.6 mg/dl.
- Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Corrected DLCO \< 50% and FEV subscript 1 or FVC \< 50% predicted.
- Cardiac EF \< 50% by 2-D Echogram.
- Prior radiation to lungs.
- Abnormal cytogenetics predictive of secondary cancers, such as -5,-7.
- 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.
- Patients with other malignancies diagnosed within 2 years prior to Study entry (except skin squamous or basal cell carcinoma).
- Active uncontrolled bacterial, viral fungal infections.
- Major surgical procedure or significant traumatic injury within 4 weeks prior to Study entry.
- Serious, non-healing wound, ulcer, or bone fracture.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Issa F. Khouri, MD / Stem Cell Transplantation
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Issa F. Khouri, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 11, 2008
Study Start
November 14, 2007
Primary Completion
March 5, 2020
Study Completion
March 5, 2020
Last Updated
February 2, 2021
Results First Posted
February 2, 2021
Record last verified: 2021-01