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Trial record 54 of 881 for:    "Reticulum Cell Sarcoma"

Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00591630
Recruitment Status : Active, not recruiting
First Posted : January 11, 2008
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Diffuse Large Cell Lymphoma Lymphoma Drug: Zevalin Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Drug: Rituximab Procedure: Stem Cell Transplant Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab Maintenance in Autologous Stem Cell Transplantation for Diffuse Large B-Cell Lymphomas
Actual Study Start Date : November 2007
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Active Comparator: Zevalin + BEAM + Rituximab +Stem Cell Transplant + Rituximab
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Drug: Zevalin
(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Other Names:
  • Ibritumomab
  • IDEC-Y2B8

Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
  • BCNU
  • BiCNU

Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid

Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrocholoride

Drug: Melphalan
140 mg/m^2 by vein.

Drug: Rituximab

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.

Other Name: Rituxan

Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
  • Stem Cell Transplantation
  • SCT

Active Comparator: Zevalin + BEAM + Rituximab +Stem Cell Transplant
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
Drug: Zevalin
(111In Zevalin) 5 millicurie (mCi) by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Other Names:
  • Ibritumomab
  • IDEC-Y2B8

Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
  • BCNU
  • BiCNU

Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid

Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrocholoride

Drug: Melphalan
140 mg/m^2 by vein.

Drug: Rituximab

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.

Other Name: Rituxan

Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
  • Stem Cell Transplantation
  • SCT

Active Comparator: BEAM + Rituximab + Stem Cell Transplant + Rituximab
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
  • BCNU
  • BiCNU

Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid

Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrocholoride

Drug: Melphalan
140 mg/m^2 by vein.

Drug: Rituximab

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.

Other Name: Rituxan

Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
  • Stem Cell Transplantation
  • SCT

Active Comparator: BEAM + Rituximab + Stem Cell Transplant
BEAM + Rituximab Followed by Stem Cell Transplant
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
  • BCNU
  • BiCNU

Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid

Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrocholoride

Drug: Melphalan
140 mg/m^2 by vein.

Drug: Rituximab

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.

Other Name: Rituxan

Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
  • Stem Cell Transplantation
  • SCT




Primary Outcome Measures :
  1. 2-Year Progression-Free Survival (PFS) Rates [ Time Frame: 2 years (beginning day 30 after treatment) ]
    Cox proportional hazards model used to evaluate the primary objective. Response evaluated using the standard criteria response for lymphoma.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed CD20-positive B-cell diffuse large cell lymphoma (demonstrated in lymph nodes or bone marrow), chemosensitive (at least PR).
  2. Age: up to 18-70 years of age.
  3. Prestudy performance status of 0, 1, or 2 according to the WHO.
  4. 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.
  5. If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
  6. 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
  7. IRB -approved signed informed consent.
  8. Patients determined to have <10% bone marrow involvement with lymphoma within 60 days before study entry as defined by bone marrow aspirates and biopsies.
  9. Female patients included must not be pregnant or lactating.
  10. 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.
  11. 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.
  12. 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. Failed stem cell collection of >/= 4x10^6CD34+/kg.
  2. Prior radioimmunotherapy.
  3. Presence of active CNS lymphoma.
  4. Patients with abnormal liver function: total bilirubin > 1.5 mg/dl.
  5. Patients with abnormal renal function: serum creatinine > 1.6 mg/dl.
  6. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  7. Corrected DLCO < 50% and FEV subscript 1 or FVC < 50% predicted.
  8. Cardiac EF < 50% by 2-D Echogram.
  9. Prior radiation to lungs.
  10. Abnormal cytogenetics predictive of secondary cancers, such as -5,-7.
  11. 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.
  12. Patients with other malignancies diagnosed within 2 years prior to Study entry (except skin squamous or basal cell carcinoma).
  13. Active uncontrolled bacterial, viral fungal infections.
  14. Major surgical procedure or significant traumatic injury within 4 weeks prior to Study entry.
  15. Serious, non-healing wound, ulcer, or bone fracture.
  16. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 3 months prior to Study entry.
  17. History of Stroke within 6 months.
  18. 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.
  19. Uncontrolled chronic diarrhea.
  20. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591630


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Issa F. Khouri, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00591630     History of Changes
Other Study ID Numbers: 2006-1018
NCI-2012-01753 ( Registry Identifier: NCI CTRP )
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Diffuse Large Cell Lymphoma
Lymphoma
Zevalin
Ibritumomab
IDEC-Y2B8
Carmustine
BCNU
BiCNU
Etoposide
VePesid
Cytarabine
Ara-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride
Melphalan
Rituximab
Rituxan
BEAM
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cytarabine
Rituximab
Etoposide
Etoposide phosphate
Melphalan
Carmustine
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents